Identification and quality control strategy of impurities in Zhengqing Fengtongning injection
Zhengqing Fengtongning injection is the sterile aqueous solution of Sinomenine Hydrochloride extracted from the root and stem of Sinomenium acutum, and is widely used to treat rheumatoid arthritis. Due to the processes of extraction, separation, purification, preparation and storage, some related im...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
Chen, Yuru [verfasserIn] |
|---|
| Format: |
E-Artikel |
|---|---|
| Sprache: |
Englisch |
| Erschienen: |
2022transfer abstract |
|---|
| Schlagwörter: |
|---|
| Übergeordnetes Werk: |
Enthalten in: Monitoring the changes in physicochemical, sensory properties and microbiota of village-type homemade yoghurts along three consecutive back-slopping procedures - Gölbaşι, Gülcan ELSEVIER, 2023, the official analytical journal of the American Association of Pharmaceutical Scientists, New York, NY [u.a.] |
|---|---|
| Übergeordnetes Werk: |
volume:219 ; year:2022 ; day:20 ; month:09 ; pages:0 |
| Links: |
|---|
| DOI / URN: |
10.1016/j.jpba.2022.114970 |
|---|
| Katalog-ID: |
ELV058575944 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | ELV058575944 | ||
| 003 | DE-627 | ||
| 005 | 20230626051149.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 221103s2022 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1016/j.jpba.2022.114970 |2 doi | |
| 028 | 5 | 2 | |a /cbs_pica/cbs_olc/import_discovery/elsevier/einzuspielen/GBV00000000001926.pica |
| 035 | |a (DE-627)ELV058575944 | ||
| 035 | |a (ELSEVIER)S0731-7085(22)00391-0 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 082 | 0 | 4 | |a 630 |a 640 |q VZ |
| 084 | |a 58.34 |2 bkl | ||
| 084 | |a 48.61 |2 bkl | ||
| 100 | 1 | |a Chen, Yuru |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Identification and quality control strategy of impurities in Zhengqing Fengtongning injection |
| 264 | 1 | |c 2022transfer abstract | |
| 336 | |a nicht spezifiziert |b zzz |2 rdacontent | ||
| 337 | |a nicht spezifiziert |b z |2 rdamedia | ||
| 338 | |a nicht spezifiziert |b zu |2 rdacarrier | ||
| 520 | |a Zhengqing Fengtongning injection is the sterile aqueous solution of Sinomenine Hydrochloride extracted from the root and stem of Sinomenium acutum, and is widely used to treat rheumatoid arthritis. Due to the processes of extraction, separation, purification, preparation and storage, some related impurities might be formed, which may cause side effects on patients. It is important to rapidly separate and identify the related impurities to ensure the safe use of Zhengqing Fengtongning injection. However, there are few literatures about the impurity in Zhengqing Fengtongning injection. In this work, ultra-high performance liquid chromatography- quadrupole time-of-flight mass spectrometry (UPLC-QTOF/MS) was developed to analyze impurities in both Zhengqing Fengtongning injection and its drug substance, with Sinomenine Hydrochloride as its active pharmaceutical ingredient (API). Six impurities of the Zhengqing Fengtongning injection were found. Structures of impurities 1 and 6 were confirmed by NMR and other impurities were identified from the fragmentation pattern of Sinomenine, the similarity of molecular weight and fragment ions in references. Finally, the HPLC analytical technique was developed to achieve the quantification of impurities 1 and 6. In addition, some reasonable suggestions are put forward on the quality control of Zhengqing Fengtongning injection and its drug substance based on the processes and structural characteristics of the related substances. The technical system established in this paper is helpful to strengthen the quality control of Zhengqing Fengtongning injection and improve production, and can also provide references for the production and quality control of similar drugs. | ||
| 520 | |a Zhengqing Fengtongning injection is the sterile aqueous solution of Sinomenine Hydrochloride extracted from the root and stem of Sinomenium acutum, and is widely used to treat rheumatoid arthritis. Due to the processes of extraction, separation, purification, preparation and storage, some related impurities might be formed, which may cause side effects on patients. It is important to rapidly separate and identify the related impurities to ensure the safe use of Zhengqing Fengtongning injection. However, there are few literatures about the impurity in Zhengqing Fengtongning injection. In this work, ultra-high performance liquid chromatography- quadrupole time-of-flight mass spectrometry (UPLC-QTOF/MS) was developed to analyze impurities in both Zhengqing Fengtongning injection and its drug substance, with Sinomenine Hydrochloride as its active pharmaceutical ingredient (API). Six impurities of the Zhengqing Fengtongning injection were found. Structures of impurities 1 and 6 were confirmed by NMR and other impurities were identified from the fragmentation pattern of Sinomenine, the similarity of molecular weight and fragment ions in references. Finally, the HPLC analytical technique was developed to achieve the quantification of impurities 1 and 6. In addition, some reasonable suggestions are put forward on the quality control of Zhengqing Fengtongning injection and its drug substance based on the processes and structural characteristics of the related substances. The technical system established in this paper is helpful to strengthen the quality control of Zhengqing Fengtongning injection and improve production, and can also provide references for the production and quality control of similar drugs. | ||
| 650 | 7 | |a Impurity |2 Elsevier | |
| 650 | 7 | |a Zhengqing Fengtongning injection |2 Elsevier | |
| 650 | 7 | |a Sinomenine Hydrochloride |2 Elsevier | |
| 650 | 7 | |a Quality control |2 Elsevier | |
| 650 | 7 | |a UPLC-QTOF/MS |2 Elsevier | |
| 650 | 7 | |a Identification |2 Elsevier | |
| 700 | 1 | |a Peng, Le |4 oth | |
| 700 | 1 | |a Wu, Honggen |4 oth | |
| 700 | 1 | |a Jia, Chaoliang |4 oth | |
| 700 | 1 | |a Zhu, Yongbo |4 oth | |
| 700 | 1 | |a Qiu, Ping |4 oth | |
| 700 | 1 | |a Tu, Pengfei |4 oth | |
| 700 | 1 | |a Li, Zheng |4 oth | |
| 700 | 1 | |a Li, Wenlong |4 oth | |
| 773 | 0 | 8 | |i Enthalten in |n Science Direct |a Gölbaşι, Gülcan ELSEVIER |t Monitoring the changes in physicochemical, sensory properties and microbiota of village-type homemade yoghurts along three consecutive back-slopping procedures |d 2023 |d the official analytical journal of the American Association of Pharmaceutical Scientists |g New York, NY [u.a.] |w (DE-627)ELV009872493 |
| 773 | 1 | 8 | |g volume:219 |g year:2022 |g day:20 |g month:09 |g pages:0 |
| 856 | 4 | 0 | |u https://doi.org/10.1016/j.jpba.2022.114970 |3 Volltext |
| 912 | |a GBV_USEFLAG_U | ||
| 912 | |a GBV_ELV | ||
| 912 | |a SYSFLAG_U | ||
| 936 | b | k | |a 58.34 |j Lebensmitteltechnologie |q VZ |
| 936 | b | k | |a 48.61 |j Tierernährung |j Tierfutter |q VZ |
| 951 | |a AR | ||
| 952 | |d 219 |j 2022 |b 20 |c 0920 |h 0 | ||
| author_variant |
y c yc |
|---|---|
| matchkey_str |
chenyurupenglewuhonggenjiachaoliangzhuyo:2022----:dniiainnqaiyotosrtgoiprteizegi |
| hierarchy_sort_str |
2022transfer abstract |
| bklnumber |
58.34 48.61 |
| publishDate |
2022 |
| allfields |
10.1016/j.jpba.2022.114970 doi /cbs_pica/cbs_olc/import_discovery/elsevier/einzuspielen/GBV00000000001926.pica (DE-627)ELV058575944 (ELSEVIER)S0731-7085(22)00391-0 DE-627 ger DE-627 rakwb eng 630 640 VZ 58.34 bkl 48.61 bkl Chen, Yuru verfasserin aut Identification and quality control strategy of impurities in Zhengqing Fengtongning injection 2022transfer abstract nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier Zhengqing Fengtongning injection is the sterile aqueous solution of Sinomenine Hydrochloride extracted from the root and stem of Sinomenium acutum, and is widely used to treat rheumatoid arthritis. Due to the processes of extraction, separation, purification, preparation and storage, some related impurities might be formed, which may cause side effects on patients. It is important to rapidly separate and identify the related impurities to ensure the safe use of Zhengqing Fengtongning injection. However, there are few literatures about the impurity in Zhengqing Fengtongning injection. In this work, ultra-high performance liquid chromatography- quadrupole time-of-flight mass spectrometry (UPLC-QTOF/MS) was developed to analyze impurities in both Zhengqing Fengtongning injection and its drug substance, with Sinomenine Hydrochloride as its active pharmaceutical ingredient (API). Six impurities of the Zhengqing Fengtongning injection were found. Structures of impurities 1 and 6 were confirmed by NMR and other impurities were identified from the fragmentation pattern of Sinomenine, the similarity of molecular weight and fragment ions in references. Finally, the HPLC analytical technique was developed to achieve the quantification of impurities 1 and 6. In addition, some reasonable suggestions are put forward on the quality control of Zhengqing Fengtongning injection and its drug substance based on the processes and structural characteristics of the related substances. The technical system established in this paper is helpful to strengthen the quality control of Zhengqing Fengtongning injection and improve production, and can also provide references for the production and quality control of similar drugs. Zhengqing Fengtongning injection is the sterile aqueous solution of Sinomenine Hydrochloride extracted from the root and stem of Sinomenium acutum, and is widely used to treat rheumatoid arthritis. Due to the processes of extraction, separation, purification, preparation and storage, some related impurities might be formed, which may cause side effects on patients. It is important to rapidly separate and identify the related impurities to ensure the safe use of Zhengqing Fengtongning injection. However, there are few literatures about the impurity in Zhengqing Fengtongning injection. In this work, ultra-high performance liquid chromatography- quadrupole time-of-flight mass spectrometry (UPLC-QTOF/MS) was developed to analyze impurities in both Zhengqing Fengtongning injection and its drug substance, with Sinomenine Hydrochloride as its active pharmaceutical ingredient (API). Six impurities of the Zhengqing Fengtongning injection were found. Structures of impurities 1 and 6 were confirmed by NMR and other impurities were identified from the fragmentation pattern of Sinomenine, the similarity of molecular weight and fragment ions in references. Finally, the HPLC analytical technique was developed to achieve the quantification of impurities 1 and 6. In addition, some reasonable suggestions are put forward on the quality control of Zhengqing Fengtongning injection and its drug substance based on the processes and structural characteristics of the related substances. The technical system established in this paper is helpful to strengthen the quality control of Zhengqing Fengtongning injection and improve production, and can also provide references for the production and quality control of similar drugs. Impurity Elsevier Zhengqing Fengtongning injection Elsevier Sinomenine Hydrochloride Elsevier Quality control Elsevier UPLC-QTOF/MS Elsevier Identification Elsevier Peng, Le oth Wu, Honggen oth Jia, Chaoliang oth Zhu, Yongbo oth Qiu, Ping oth Tu, Pengfei oth Li, Zheng oth Li, Wenlong oth Enthalten in Science Direct Gölbaşι, Gülcan ELSEVIER Monitoring the changes in physicochemical, sensory properties and microbiota of village-type homemade yoghurts along three consecutive back-slopping procedures 2023 the official analytical journal of the American Association of Pharmaceutical Scientists New York, NY [u.a.] (DE-627)ELV009872493 volume:219 year:2022 day:20 month:09 pages:0 https://doi.org/10.1016/j.jpba.2022.114970 Volltext GBV_USEFLAG_U GBV_ELV SYSFLAG_U 58.34 Lebensmitteltechnologie VZ 48.61 Tierernährung Tierfutter VZ AR 219 2022 20 0920 0 |
| spelling |
10.1016/j.jpba.2022.114970 doi /cbs_pica/cbs_olc/import_discovery/elsevier/einzuspielen/GBV00000000001926.pica (DE-627)ELV058575944 (ELSEVIER)S0731-7085(22)00391-0 DE-627 ger DE-627 rakwb eng 630 640 VZ 58.34 bkl 48.61 bkl Chen, Yuru verfasserin aut Identification and quality control strategy of impurities in Zhengqing Fengtongning injection 2022transfer abstract nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier Zhengqing Fengtongning injection is the sterile aqueous solution of Sinomenine Hydrochloride extracted from the root and stem of Sinomenium acutum, and is widely used to treat rheumatoid arthritis. Due to the processes of extraction, separation, purification, preparation and storage, some related impurities might be formed, which may cause side effects on patients. It is important to rapidly separate and identify the related impurities to ensure the safe use of Zhengqing Fengtongning injection. However, there are few literatures about the impurity in Zhengqing Fengtongning injection. In this work, ultra-high performance liquid chromatography- quadrupole time-of-flight mass spectrometry (UPLC-QTOF/MS) was developed to analyze impurities in both Zhengqing Fengtongning injection and its drug substance, with Sinomenine Hydrochloride as its active pharmaceutical ingredient (API). Six impurities of the Zhengqing Fengtongning injection were found. Structures of impurities 1 and 6 were confirmed by NMR and other impurities were identified from the fragmentation pattern of Sinomenine, the similarity of molecular weight and fragment ions in references. Finally, the HPLC analytical technique was developed to achieve the quantification of impurities 1 and 6. In addition, some reasonable suggestions are put forward on the quality control of Zhengqing Fengtongning injection and its drug substance based on the processes and structural characteristics of the related substances. The technical system established in this paper is helpful to strengthen the quality control of Zhengqing Fengtongning injection and improve production, and can also provide references for the production and quality control of similar drugs. Zhengqing Fengtongning injection is the sterile aqueous solution of Sinomenine Hydrochloride extracted from the root and stem of Sinomenium acutum, and is widely used to treat rheumatoid arthritis. Due to the processes of extraction, separation, purification, preparation and storage, some related impurities might be formed, which may cause side effects on patients. It is important to rapidly separate and identify the related impurities to ensure the safe use of Zhengqing Fengtongning injection. However, there are few literatures about the impurity in Zhengqing Fengtongning injection. In this work, ultra-high performance liquid chromatography- quadrupole time-of-flight mass spectrometry (UPLC-QTOF/MS) was developed to analyze impurities in both Zhengqing Fengtongning injection and its drug substance, with Sinomenine Hydrochloride as its active pharmaceutical ingredient (API). Six impurities of the Zhengqing Fengtongning injection were found. Structures of impurities 1 and 6 were confirmed by NMR and other impurities were identified from the fragmentation pattern of Sinomenine, the similarity of molecular weight and fragment ions in references. Finally, the HPLC analytical technique was developed to achieve the quantification of impurities 1 and 6. In addition, some reasonable suggestions are put forward on the quality control of Zhengqing Fengtongning injection and its drug substance based on the processes and structural characteristics of the related substances. The technical system established in this paper is helpful to strengthen the quality control of Zhengqing Fengtongning injection and improve production, and can also provide references for the production and quality control of similar drugs. Impurity Elsevier Zhengqing Fengtongning injection Elsevier Sinomenine Hydrochloride Elsevier Quality control Elsevier UPLC-QTOF/MS Elsevier Identification Elsevier Peng, Le oth Wu, Honggen oth Jia, Chaoliang oth Zhu, Yongbo oth Qiu, Ping oth Tu, Pengfei oth Li, Zheng oth Li, Wenlong oth Enthalten in Science Direct Gölbaşι, Gülcan ELSEVIER Monitoring the changes in physicochemical, sensory properties and microbiota of village-type homemade yoghurts along three consecutive back-slopping procedures 2023 the official analytical journal of the American Association of Pharmaceutical Scientists New York, NY [u.a.] (DE-627)ELV009872493 volume:219 year:2022 day:20 month:09 pages:0 https://doi.org/10.1016/j.jpba.2022.114970 Volltext GBV_USEFLAG_U GBV_ELV SYSFLAG_U 58.34 Lebensmitteltechnologie VZ 48.61 Tierernährung Tierfutter VZ AR 219 2022 20 0920 0 |
| allfields_unstemmed |
10.1016/j.jpba.2022.114970 doi /cbs_pica/cbs_olc/import_discovery/elsevier/einzuspielen/GBV00000000001926.pica (DE-627)ELV058575944 (ELSEVIER)S0731-7085(22)00391-0 DE-627 ger DE-627 rakwb eng 630 640 VZ 58.34 bkl 48.61 bkl Chen, Yuru verfasserin aut Identification and quality control strategy of impurities in Zhengqing Fengtongning injection 2022transfer abstract nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier Zhengqing Fengtongning injection is the sterile aqueous solution of Sinomenine Hydrochloride extracted from the root and stem of Sinomenium acutum, and is widely used to treat rheumatoid arthritis. Due to the processes of extraction, separation, purification, preparation and storage, some related impurities might be formed, which may cause side effects on patients. It is important to rapidly separate and identify the related impurities to ensure the safe use of Zhengqing Fengtongning injection. However, there are few literatures about the impurity in Zhengqing Fengtongning injection. In this work, ultra-high performance liquid chromatography- quadrupole time-of-flight mass spectrometry (UPLC-QTOF/MS) was developed to analyze impurities in both Zhengqing Fengtongning injection and its drug substance, with Sinomenine Hydrochloride as its active pharmaceutical ingredient (API). Six impurities of the Zhengqing Fengtongning injection were found. Structures of impurities 1 and 6 were confirmed by NMR and other impurities were identified from the fragmentation pattern of Sinomenine, the similarity of molecular weight and fragment ions in references. Finally, the HPLC analytical technique was developed to achieve the quantification of impurities 1 and 6. In addition, some reasonable suggestions are put forward on the quality control of Zhengqing Fengtongning injection and its drug substance based on the processes and structural characteristics of the related substances. The technical system established in this paper is helpful to strengthen the quality control of Zhengqing Fengtongning injection and improve production, and can also provide references for the production and quality control of similar drugs. Zhengqing Fengtongning injection is the sterile aqueous solution of Sinomenine Hydrochloride extracted from the root and stem of Sinomenium acutum, and is widely used to treat rheumatoid arthritis. Due to the processes of extraction, separation, purification, preparation and storage, some related impurities might be formed, which may cause side effects on patients. It is important to rapidly separate and identify the related impurities to ensure the safe use of Zhengqing Fengtongning injection. However, there are few literatures about the impurity in Zhengqing Fengtongning injection. In this work, ultra-high performance liquid chromatography- quadrupole time-of-flight mass spectrometry (UPLC-QTOF/MS) was developed to analyze impurities in both Zhengqing Fengtongning injection and its drug substance, with Sinomenine Hydrochloride as its active pharmaceutical ingredient (API). Six impurities of the Zhengqing Fengtongning injection were found. Structures of impurities 1 and 6 were confirmed by NMR and other impurities were identified from the fragmentation pattern of Sinomenine, the similarity of molecular weight and fragment ions in references. Finally, the HPLC analytical technique was developed to achieve the quantification of impurities 1 and 6. In addition, some reasonable suggestions are put forward on the quality control of Zhengqing Fengtongning injection and its drug substance based on the processes and structural characteristics of the related substances. The technical system established in this paper is helpful to strengthen the quality control of Zhengqing Fengtongning injection and improve production, and can also provide references for the production and quality control of similar drugs. Impurity Elsevier Zhengqing Fengtongning injection Elsevier Sinomenine Hydrochloride Elsevier Quality control Elsevier UPLC-QTOF/MS Elsevier Identification Elsevier Peng, Le oth Wu, Honggen oth Jia, Chaoliang oth Zhu, Yongbo oth Qiu, Ping oth Tu, Pengfei oth Li, Zheng oth Li, Wenlong oth Enthalten in Science Direct Gölbaşι, Gülcan ELSEVIER Monitoring the changes in physicochemical, sensory properties and microbiota of village-type homemade yoghurts along three consecutive back-slopping procedures 2023 the official analytical journal of the American Association of Pharmaceutical Scientists New York, NY [u.a.] (DE-627)ELV009872493 volume:219 year:2022 day:20 month:09 pages:0 https://doi.org/10.1016/j.jpba.2022.114970 Volltext GBV_USEFLAG_U GBV_ELV SYSFLAG_U 58.34 Lebensmitteltechnologie VZ 48.61 Tierernährung Tierfutter VZ AR 219 2022 20 0920 0 |
| allfieldsGer |
10.1016/j.jpba.2022.114970 doi /cbs_pica/cbs_olc/import_discovery/elsevier/einzuspielen/GBV00000000001926.pica (DE-627)ELV058575944 (ELSEVIER)S0731-7085(22)00391-0 DE-627 ger DE-627 rakwb eng 630 640 VZ 58.34 bkl 48.61 bkl Chen, Yuru verfasserin aut Identification and quality control strategy of impurities in Zhengqing Fengtongning injection 2022transfer abstract nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier Zhengqing Fengtongning injection is the sterile aqueous solution of Sinomenine Hydrochloride extracted from the root and stem of Sinomenium acutum, and is widely used to treat rheumatoid arthritis. Due to the processes of extraction, separation, purification, preparation and storage, some related impurities might be formed, which may cause side effects on patients. It is important to rapidly separate and identify the related impurities to ensure the safe use of Zhengqing Fengtongning injection. However, there are few literatures about the impurity in Zhengqing Fengtongning injection. In this work, ultra-high performance liquid chromatography- quadrupole time-of-flight mass spectrometry (UPLC-QTOF/MS) was developed to analyze impurities in both Zhengqing Fengtongning injection and its drug substance, with Sinomenine Hydrochloride as its active pharmaceutical ingredient (API). Six impurities of the Zhengqing Fengtongning injection were found. Structures of impurities 1 and 6 were confirmed by NMR and other impurities were identified from the fragmentation pattern of Sinomenine, the similarity of molecular weight and fragment ions in references. Finally, the HPLC analytical technique was developed to achieve the quantification of impurities 1 and 6. In addition, some reasonable suggestions are put forward on the quality control of Zhengqing Fengtongning injection and its drug substance based on the processes and structural characteristics of the related substances. The technical system established in this paper is helpful to strengthen the quality control of Zhengqing Fengtongning injection and improve production, and can also provide references for the production and quality control of similar drugs. Zhengqing Fengtongning injection is the sterile aqueous solution of Sinomenine Hydrochloride extracted from the root and stem of Sinomenium acutum, and is widely used to treat rheumatoid arthritis. Due to the processes of extraction, separation, purification, preparation and storage, some related impurities might be formed, which may cause side effects on patients. It is important to rapidly separate and identify the related impurities to ensure the safe use of Zhengqing Fengtongning injection. However, there are few literatures about the impurity in Zhengqing Fengtongning injection. In this work, ultra-high performance liquid chromatography- quadrupole time-of-flight mass spectrometry (UPLC-QTOF/MS) was developed to analyze impurities in both Zhengqing Fengtongning injection and its drug substance, with Sinomenine Hydrochloride as its active pharmaceutical ingredient (API). Six impurities of the Zhengqing Fengtongning injection were found. Structures of impurities 1 and 6 were confirmed by NMR and other impurities were identified from the fragmentation pattern of Sinomenine, the similarity of molecular weight and fragment ions in references. Finally, the HPLC analytical technique was developed to achieve the quantification of impurities 1 and 6. In addition, some reasonable suggestions are put forward on the quality control of Zhengqing Fengtongning injection and its drug substance based on the processes and structural characteristics of the related substances. The technical system established in this paper is helpful to strengthen the quality control of Zhengqing Fengtongning injection and improve production, and can also provide references for the production and quality control of similar drugs. Impurity Elsevier Zhengqing Fengtongning injection Elsevier Sinomenine Hydrochloride Elsevier Quality control Elsevier UPLC-QTOF/MS Elsevier Identification Elsevier Peng, Le oth Wu, Honggen oth Jia, Chaoliang oth Zhu, Yongbo oth Qiu, Ping oth Tu, Pengfei oth Li, Zheng oth Li, Wenlong oth Enthalten in Science Direct Gölbaşι, Gülcan ELSEVIER Monitoring the changes in physicochemical, sensory properties and microbiota of village-type homemade yoghurts along three consecutive back-slopping procedures 2023 the official analytical journal of the American Association of Pharmaceutical Scientists New York, NY [u.a.] (DE-627)ELV009872493 volume:219 year:2022 day:20 month:09 pages:0 https://doi.org/10.1016/j.jpba.2022.114970 Volltext GBV_USEFLAG_U GBV_ELV SYSFLAG_U 58.34 Lebensmitteltechnologie VZ 48.61 Tierernährung Tierfutter VZ AR 219 2022 20 0920 0 |
| allfieldsSound |
10.1016/j.jpba.2022.114970 doi /cbs_pica/cbs_olc/import_discovery/elsevier/einzuspielen/GBV00000000001926.pica (DE-627)ELV058575944 (ELSEVIER)S0731-7085(22)00391-0 DE-627 ger DE-627 rakwb eng 630 640 VZ 58.34 bkl 48.61 bkl Chen, Yuru verfasserin aut Identification and quality control strategy of impurities in Zhengqing Fengtongning injection 2022transfer abstract nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier Zhengqing Fengtongning injection is the sterile aqueous solution of Sinomenine Hydrochloride extracted from the root and stem of Sinomenium acutum, and is widely used to treat rheumatoid arthritis. Due to the processes of extraction, separation, purification, preparation and storage, some related impurities might be formed, which may cause side effects on patients. It is important to rapidly separate and identify the related impurities to ensure the safe use of Zhengqing Fengtongning injection. However, there are few literatures about the impurity in Zhengqing Fengtongning injection. In this work, ultra-high performance liquid chromatography- quadrupole time-of-flight mass spectrometry (UPLC-QTOF/MS) was developed to analyze impurities in both Zhengqing Fengtongning injection and its drug substance, with Sinomenine Hydrochloride as its active pharmaceutical ingredient (API). Six impurities of the Zhengqing Fengtongning injection were found. Structures of impurities 1 and 6 were confirmed by NMR and other impurities were identified from the fragmentation pattern of Sinomenine, the similarity of molecular weight and fragment ions in references. Finally, the HPLC analytical technique was developed to achieve the quantification of impurities 1 and 6. In addition, some reasonable suggestions are put forward on the quality control of Zhengqing Fengtongning injection and its drug substance based on the processes and structural characteristics of the related substances. The technical system established in this paper is helpful to strengthen the quality control of Zhengqing Fengtongning injection and improve production, and can also provide references for the production and quality control of similar drugs. Zhengqing Fengtongning injection is the sterile aqueous solution of Sinomenine Hydrochloride extracted from the root and stem of Sinomenium acutum, and is widely used to treat rheumatoid arthritis. Due to the processes of extraction, separation, purification, preparation and storage, some related impurities might be formed, which may cause side effects on patients. It is important to rapidly separate and identify the related impurities to ensure the safe use of Zhengqing Fengtongning injection. However, there are few literatures about the impurity in Zhengqing Fengtongning injection. In this work, ultra-high performance liquid chromatography- quadrupole time-of-flight mass spectrometry (UPLC-QTOF/MS) was developed to analyze impurities in both Zhengqing Fengtongning injection and its drug substance, with Sinomenine Hydrochloride as its active pharmaceutical ingredient (API). Six impurities of the Zhengqing Fengtongning injection were found. Structures of impurities 1 and 6 were confirmed by NMR and other impurities were identified from the fragmentation pattern of Sinomenine, the similarity of molecular weight and fragment ions in references. Finally, the HPLC analytical technique was developed to achieve the quantification of impurities 1 and 6. In addition, some reasonable suggestions are put forward on the quality control of Zhengqing Fengtongning injection and its drug substance based on the processes and structural characteristics of the related substances. The technical system established in this paper is helpful to strengthen the quality control of Zhengqing Fengtongning injection and improve production, and can also provide references for the production and quality control of similar drugs. Impurity Elsevier Zhengqing Fengtongning injection Elsevier Sinomenine Hydrochloride Elsevier Quality control Elsevier UPLC-QTOF/MS Elsevier Identification Elsevier Peng, Le oth Wu, Honggen oth Jia, Chaoliang oth Zhu, Yongbo oth Qiu, Ping oth Tu, Pengfei oth Li, Zheng oth Li, Wenlong oth Enthalten in Science Direct Gölbaşι, Gülcan ELSEVIER Monitoring the changes in physicochemical, sensory properties and microbiota of village-type homemade yoghurts along three consecutive back-slopping procedures 2023 the official analytical journal of the American Association of Pharmaceutical Scientists New York, NY [u.a.] (DE-627)ELV009872493 volume:219 year:2022 day:20 month:09 pages:0 https://doi.org/10.1016/j.jpba.2022.114970 Volltext GBV_USEFLAG_U GBV_ELV SYSFLAG_U 58.34 Lebensmitteltechnologie VZ 48.61 Tierernährung Tierfutter VZ AR 219 2022 20 0920 0 |
| language |
English |
| source |
Enthalten in Monitoring the changes in physicochemical, sensory properties and microbiota of village-type homemade yoghurts along three consecutive back-slopping procedures New York, NY [u.a.] volume:219 year:2022 day:20 month:09 pages:0 |
| sourceStr |
Enthalten in Monitoring the changes in physicochemical, sensory properties and microbiota of village-type homemade yoghurts along three consecutive back-slopping procedures New York, NY [u.a.] volume:219 year:2022 day:20 month:09 pages:0 |
| format_phy_str_mv |
Article |
| bklname |
Lebensmitteltechnologie Tierernährung Tierfutter |
| institution |
findex.gbv.de |
| topic_facet |
Impurity Zhengqing Fengtongning injection Sinomenine Hydrochloride Quality control UPLC-QTOF/MS Identification |
| dewey-raw |
630 |
| isfreeaccess_bool |
false |
| container_title |
Monitoring the changes in physicochemical, sensory properties and microbiota of village-type homemade yoghurts along three consecutive back-slopping procedures |
| authorswithroles_txt_mv |
Chen, Yuru @@aut@@ Peng, Le @@oth@@ Wu, Honggen @@oth@@ Jia, Chaoliang @@oth@@ Zhu, Yongbo @@oth@@ Qiu, Ping @@oth@@ Tu, Pengfei @@oth@@ Li, Zheng @@oth@@ Li, Wenlong @@oth@@ |
| publishDateDaySort_date |
2022-01-20T00:00:00Z |
| hierarchy_top_id |
ELV009872493 |
| dewey-sort |
3630 |
| id |
ELV058575944 |
| language_de |
englisch |
| fullrecord |
<?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01000caa a22002652 4500</leader><controlfield tag="001">ELV058575944</controlfield><controlfield tag="003">DE-627</controlfield><controlfield tag="005">20230626051149.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">221103s2022 xx |||||o 00| ||eng c</controlfield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.1016/j.jpba.2022.114970</subfield><subfield code="2">doi</subfield></datafield><datafield tag="028" ind1="5" ind2="2"><subfield code="a">/cbs_pica/cbs_olc/import_discovery/elsevier/einzuspielen/GBV00000000001926.pica</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627)ELV058575944</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(ELSEVIER)S0731-7085(22)00391-0</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-627</subfield><subfield code="b">ger</subfield><subfield code="c">DE-627</subfield><subfield code="e">rakwb</subfield></datafield><datafield tag="041" ind1=" " ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="082" ind1="0" ind2="4"><subfield code="a">630</subfield><subfield code="a">640</subfield><subfield code="q">VZ</subfield></datafield><datafield tag="084" ind1=" " ind2=" "><subfield code="a">58.34</subfield><subfield code="2">bkl</subfield></datafield><datafield tag="084" ind1=" " ind2=" "><subfield code="a">48.61</subfield><subfield code="2">bkl</subfield></datafield><datafield tag="100" ind1="1" ind2=" "><subfield code="a">Chen, Yuru</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">Identification and quality control strategy of impurities in Zhengqing Fengtongning injection</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2022transfer abstract</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">nicht spezifiziert</subfield><subfield code="b">zzz</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">nicht spezifiziert</subfield><subfield code="b">z</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">nicht spezifiziert</subfield><subfield code="b">zu</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">Zhengqing Fengtongning injection is the sterile aqueous solution of Sinomenine Hydrochloride extracted from the root and stem of Sinomenium acutum, and is widely used to treat rheumatoid arthritis. Due to the processes of extraction, separation, purification, preparation and storage, some related impurities might be formed, which may cause side effects on patients. It is important to rapidly separate and identify the related impurities to ensure the safe use of Zhengqing Fengtongning injection. However, there are few literatures about the impurity in Zhengqing Fengtongning injection. In this work, ultra-high performance liquid chromatography- quadrupole time-of-flight mass spectrometry (UPLC-QTOF/MS) was developed to analyze impurities in both Zhengqing Fengtongning injection and its drug substance, with Sinomenine Hydrochloride as its active pharmaceutical ingredient (API). Six impurities of the Zhengqing Fengtongning injection were found. Structures of impurities 1 and 6 were confirmed by NMR and other impurities were identified from the fragmentation pattern of Sinomenine, the similarity of molecular weight and fragment ions in references. Finally, the HPLC analytical technique was developed to achieve the quantification of impurities 1 and 6. In addition, some reasonable suggestions are put forward on the quality control of Zhengqing Fengtongning injection and its drug substance based on the processes and structural characteristics of the related substances. The technical system established in this paper is helpful to strengthen the quality control of Zhengqing Fengtongning injection and improve production, and can also provide references for the production and quality control of similar drugs.</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">Zhengqing Fengtongning injection is the sterile aqueous solution of Sinomenine Hydrochloride extracted from the root and stem of Sinomenium acutum, and is widely used to treat rheumatoid arthritis. Due to the processes of extraction, separation, purification, preparation and storage, some related impurities might be formed, which may cause side effects on patients. It is important to rapidly separate and identify the related impurities to ensure the safe use of Zhengqing Fengtongning injection. However, there are few literatures about the impurity in Zhengqing Fengtongning injection. In this work, ultra-high performance liquid chromatography- quadrupole time-of-flight mass spectrometry (UPLC-QTOF/MS) was developed to analyze impurities in both Zhengqing Fengtongning injection and its drug substance, with Sinomenine Hydrochloride as its active pharmaceutical ingredient (API). Six impurities of the Zhengqing Fengtongning injection were found. Structures of impurities 1 and 6 were confirmed by NMR and other impurities were identified from the fragmentation pattern of Sinomenine, the similarity of molecular weight and fragment ions in references. Finally, the HPLC analytical technique was developed to achieve the quantification of impurities 1 and 6. In addition, some reasonable suggestions are put forward on the quality control of Zhengqing Fengtongning injection and its drug substance based on the processes and structural characteristics of the related substances. The technical system established in this paper is helpful to strengthen the quality control of Zhengqing Fengtongning injection and improve production, and can also provide references for the production and quality control of similar drugs.</subfield></datafield><datafield tag="650" ind1=" " ind2="7"><subfield code="a">Impurity</subfield><subfield code="2">Elsevier</subfield></datafield><datafield tag="650" ind1=" " ind2="7"><subfield code="a">Zhengqing Fengtongning injection</subfield><subfield code="2">Elsevier</subfield></datafield><datafield tag="650" ind1=" " ind2="7"><subfield code="a">Sinomenine Hydrochloride</subfield><subfield code="2">Elsevier</subfield></datafield><datafield tag="650" ind1=" " ind2="7"><subfield code="a">Quality control</subfield><subfield code="2">Elsevier</subfield></datafield><datafield tag="650" ind1=" " ind2="7"><subfield code="a">UPLC-QTOF/MS</subfield><subfield code="2">Elsevier</subfield></datafield><datafield tag="650" ind1=" " ind2="7"><subfield code="a">Identification</subfield><subfield code="2">Elsevier</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Peng, Le</subfield><subfield code="4">oth</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Wu, Honggen</subfield><subfield code="4">oth</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Jia, Chaoliang</subfield><subfield code="4">oth</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Zhu, Yongbo</subfield><subfield code="4">oth</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Qiu, Ping</subfield><subfield code="4">oth</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Tu, Pengfei</subfield><subfield code="4">oth</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Li, Zheng</subfield><subfield code="4">oth</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Li, Wenlong</subfield><subfield code="4">oth</subfield></datafield><datafield tag="773" ind1="0" ind2="8"><subfield code="i">Enthalten in</subfield><subfield code="n">Science Direct</subfield><subfield code="a">Gölbaşι, Gülcan ELSEVIER</subfield><subfield code="t">Monitoring the changes in physicochemical, sensory properties and microbiota of village-type homemade yoghurts along three consecutive back-slopping procedures</subfield><subfield code="d">2023</subfield><subfield code="d">the official analytical journal of the American Association of Pharmaceutical Scientists</subfield><subfield code="g">New York, NY [u.a.]</subfield><subfield code="w">(DE-627)ELV009872493</subfield></datafield><datafield tag="773" ind1="1" ind2="8"><subfield code="g">volume:219</subfield><subfield code="g">year:2022</subfield><subfield code="g">day:20</subfield><subfield code="g">month:09</subfield><subfield code="g">pages:0</subfield></datafield><datafield tag="856" ind1="4" ind2="0"><subfield code="u">https://doi.org/10.1016/j.jpba.2022.114970</subfield><subfield code="3">Volltext</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_USEFLAG_U</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ELV</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">SYSFLAG_U</subfield></datafield><datafield tag="936" ind1="b" ind2="k"><subfield code="a">58.34</subfield><subfield code="j">Lebensmitteltechnologie</subfield><subfield code="q">VZ</subfield></datafield><datafield tag="936" ind1="b" ind2="k"><subfield code="a">48.61</subfield><subfield code="j">Tierernährung</subfield><subfield code="j">Tierfutter</subfield><subfield code="q">VZ</subfield></datafield><datafield tag="951" ind1=" " ind2=" "><subfield code="a">AR</subfield></datafield><datafield tag="952" ind1=" " ind2=" "><subfield code="d">219</subfield><subfield code="j">2022</subfield><subfield code="b">20</subfield><subfield code="c">0920</subfield><subfield code="h">0</subfield></datafield></record></collection>
|
| author |
Chen, Yuru |
| spellingShingle |
Chen, Yuru ddc 630 bkl 58.34 bkl 48.61 Elsevier Impurity Elsevier Zhengqing Fengtongning injection Elsevier Sinomenine Hydrochloride Elsevier Quality control Elsevier UPLC-QTOF/MS Elsevier Identification Identification and quality control strategy of impurities in Zhengqing Fengtongning injection |
| authorStr |
Chen, Yuru |
| ppnlink_with_tag_str_mv |
@@773@@(DE-627)ELV009872493 |
| format |
electronic Article |
| dewey-ones |
630 - Agriculture & related technologies 640 - Home & family management |
| delete_txt_mv |
keep |
| author_role |
aut |
| collection |
elsevier |
| remote_str |
true |
| illustrated |
Not Illustrated |
| topic_title |
630 640 VZ 58.34 bkl 48.61 bkl Identification and quality control strategy of impurities in Zhengqing Fengtongning injection Impurity Elsevier Zhengqing Fengtongning injection Elsevier Sinomenine Hydrochloride Elsevier Quality control Elsevier UPLC-QTOF/MS Elsevier Identification Elsevier |
| topic |
ddc 630 bkl 58.34 bkl 48.61 Elsevier Impurity Elsevier Zhengqing Fengtongning injection Elsevier Sinomenine Hydrochloride Elsevier Quality control Elsevier UPLC-QTOF/MS Elsevier Identification |
| topic_unstemmed |
ddc 630 bkl 58.34 bkl 48.61 Elsevier Impurity Elsevier Zhengqing Fengtongning injection Elsevier Sinomenine Hydrochloride Elsevier Quality control Elsevier UPLC-QTOF/MS Elsevier Identification |
| topic_browse |
ddc 630 bkl 58.34 bkl 48.61 Elsevier Impurity Elsevier Zhengqing Fengtongning injection Elsevier Sinomenine Hydrochloride Elsevier Quality control Elsevier UPLC-QTOF/MS Elsevier Identification |
| format_facet |
Elektronische Aufsätze Aufsätze Elektronische Ressource |
| format_main_str_mv |
Text Zeitschrift/Artikel |
| carriertype_str_mv |
zu |
| author2_variant |
l p lp h w hw c j cj y z yz p q pq p t pt z l zl w l wl |
| hierarchy_parent_title |
Monitoring the changes in physicochemical, sensory properties and microbiota of village-type homemade yoghurts along three consecutive back-slopping procedures |
| hierarchy_parent_id |
ELV009872493 |
| dewey-tens |
630 - Agriculture 640 - Home & family management |
| hierarchy_top_title |
Monitoring the changes in physicochemical, sensory properties and microbiota of village-type homemade yoghurts along three consecutive back-slopping procedures |
| isfreeaccess_txt |
false |
| familylinks_str_mv |
(DE-627)ELV009872493 |
| title |
Identification and quality control strategy of impurities in Zhengqing Fengtongning injection |
| ctrlnum |
(DE-627)ELV058575944 (ELSEVIER)S0731-7085(22)00391-0 |
| title_full |
Identification and quality control strategy of impurities in Zhengqing Fengtongning injection |
| author_sort |
Chen, Yuru |
| journal |
Monitoring the changes in physicochemical, sensory properties and microbiota of village-type homemade yoghurts along three consecutive back-slopping procedures |
| journalStr |
Monitoring the changes in physicochemical, sensory properties and microbiota of village-type homemade yoghurts along three consecutive back-slopping procedures |
| lang_code |
eng |
| isOA_bool |
false |
| dewey-hundreds |
600 - Technology |
| recordtype |
marc |
| publishDateSort |
2022 |
| contenttype_str_mv |
zzz |
| container_start_page |
0 |
| author_browse |
Chen, Yuru |
| container_volume |
219 |
| class |
630 640 VZ 58.34 bkl 48.61 bkl |
| format_se |
Elektronische Aufsätze |
| author-letter |
Chen, Yuru |
| doi_str_mv |
10.1016/j.jpba.2022.114970 |
| dewey-full |
630 640 |
| title_sort |
identification and quality control strategy of impurities in zhengqing fengtongning injection |
| title_auth |
Identification and quality control strategy of impurities in Zhengqing Fengtongning injection |
| abstract |
Zhengqing Fengtongning injection is the sterile aqueous solution of Sinomenine Hydrochloride extracted from the root and stem of Sinomenium acutum, and is widely used to treat rheumatoid arthritis. Due to the processes of extraction, separation, purification, preparation and storage, some related impurities might be formed, which may cause side effects on patients. It is important to rapidly separate and identify the related impurities to ensure the safe use of Zhengqing Fengtongning injection. However, there are few literatures about the impurity in Zhengqing Fengtongning injection. In this work, ultra-high performance liquid chromatography- quadrupole time-of-flight mass spectrometry (UPLC-QTOF/MS) was developed to analyze impurities in both Zhengqing Fengtongning injection and its drug substance, with Sinomenine Hydrochloride as its active pharmaceutical ingredient (API). Six impurities of the Zhengqing Fengtongning injection were found. Structures of impurities 1 and 6 were confirmed by NMR and other impurities were identified from the fragmentation pattern of Sinomenine, the similarity of molecular weight and fragment ions in references. Finally, the HPLC analytical technique was developed to achieve the quantification of impurities 1 and 6. In addition, some reasonable suggestions are put forward on the quality control of Zhengqing Fengtongning injection and its drug substance based on the processes and structural characteristics of the related substances. The technical system established in this paper is helpful to strengthen the quality control of Zhengqing Fengtongning injection and improve production, and can also provide references for the production and quality control of similar drugs. |
| abstractGer |
Zhengqing Fengtongning injection is the sterile aqueous solution of Sinomenine Hydrochloride extracted from the root and stem of Sinomenium acutum, and is widely used to treat rheumatoid arthritis. Due to the processes of extraction, separation, purification, preparation and storage, some related impurities might be formed, which may cause side effects on patients. It is important to rapidly separate and identify the related impurities to ensure the safe use of Zhengqing Fengtongning injection. However, there are few literatures about the impurity in Zhengqing Fengtongning injection. In this work, ultra-high performance liquid chromatography- quadrupole time-of-flight mass spectrometry (UPLC-QTOF/MS) was developed to analyze impurities in both Zhengqing Fengtongning injection and its drug substance, with Sinomenine Hydrochloride as its active pharmaceutical ingredient (API). Six impurities of the Zhengqing Fengtongning injection were found. Structures of impurities 1 and 6 were confirmed by NMR and other impurities were identified from the fragmentation pattern of Sinomenine, the similarity of molecular weight and fragment ions in references. Finally, the HPLC analytical technique was developed to achieve the quantification of impurities 1 and 6. In addition, some reasonable suggestions are put forward on the quality control of Zhengqing Fengtongning injection and its drug substance based on the processes and structural characteristics of the related substances. The technical system established in this paper is helpful to strengthen the quality control of Zhengqing Fengtongning injection and improve production, and can also provide references for the production and quality control of similar drugs. |
| abstract_unstemmed |
Zhengqing Fengtongning injection is the sterile aqueous solution of Sinomenine Hydrochloride extracted from the root and stem of Sinomenium acutum, and is widely used to treat rheumatoid arthritis. Due to the processes of extraction, separation, purification, preparation and storage, some related impurities might be formed, which may cause side effects on patients. It is important to rapidly separate and identify the related impurities to ensure the safe use of Zhengqing Fengtongning injection. However, there are few literatures about the impurity in Zhengqing Fengtongning injection. In this work, ultra-high performance liquid chromatography- quadrupole time-of-flight mass spectrometry (UPLC-QTOF/MS) was developed to analyze impurities in both Zhengqing Fengtongning injection and its drug substance, with Sinomenine Hydrochloride as its active pharmaceutical ingredient (API). Six impurities of the Zhengqing Fengtongning injection were found. Structures of impurities 1 and 6 were confirmed by NMR and other impurities were identified from the fragmentation pattern of Sinomenine, the similarity of molecular weight and fragment ions in references. Finally, the HPLC analytical technique was developed to achieve the quantification of impurities 1 and 6. In addition, some reasonable suggestions are put forward on the quality control of Zhengqing Fengtongning injection and its drug substance based on the processes and structural characteristics of the related substances. The technical system established in this paper is helpful to strengthen the quality control of Zhengqing Fengtongning injection and improve production, and can also provide references for the production and quality control of similar drugs. |
| collection_details |
GBV_USEFLAG_U GBV_ELV SYSFLAG_U |
| title_short |
Identification and quality control strategy of impurities in Zhengqing Fengtongning injection |
| url |
https://doi.org/10.1016/j.jpba.2022.114970 |
| remote_bool |
true |
| author2 |
Peng, Le Wu, Honggen Jia, Chaoliang Zhu, Yongbo Qiu, Ping Tu, Pengfei Li, Zheng Li, Wenlong |
| author2Str |
Peng, Le Wu, Honggen Jia, Chaoliang Zhu, Yongbo Qiu, Ping Tu, Pengfei Li, Zheng Li, Wenlong |
| ppnlink |
ELV009872493 |
| mediatype_str_mv |
z |
| isOA_txt |
false |
| hochschulschrift_bool |
false |
| author2_role |
oth oth oth oth oth oth oth oth |
| doi_str |
10.1016/j.jpba.2022.114970 |
| up_date |
2024-07-06T19:25:52.375Z |
| _version_ |
1803858951405568000 |
| fullrecord_marcxml |
<?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01000caa a22002652 4500</leader><controlfield tag="001">ELV058575944</controlfield><controlfield tag="003">DE-627</controlfield><controlfield tag="005">20230626051149.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">221103s2022 xx |||||o 00| ||eng c</controlfield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.1016/j.jpba.2022.114970</subfield><subfield code="2">doi</subfield></datafield><datafield tag="028" ind1="5" ind2="2"><subfield code="a">/cbs_pica/cbs_olc/import_discovery/elsevier/einzuspielen/GBV00000000001926.pica</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627)ELV058575944</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(ELSEVIER)S0731-7085(22)00391-0</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-627</subfield><subfield code="b">ger</subfield><subfield code="c">DE-627</subfield><subfield code="e">rakwb</subfield></datafield><datafield tag="041" ind1=" " ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="082" ind1="0" ind2="4"><subfield code="a">630</subfield><subfield code="a">640</subfield><subfield code="q">VZ</subfield></datafield><datafield tag="084" ind1=" " ind2=" "><subfield code="a">58.34</subfield><subfield code="2">bkl</subfield></datafield><datafield tag="084" ind1=" " ind2=" "><subfield code="a">48.61</subfield><subfield code="2">bkl</subfield></datafield><datafield tag="100" ind1="1" ind2=" "><subfield code="a">Chen, Yuru</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">Identification and quality control strategy of impurities in Zhengqing Fengtongning injection</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2022transfer abstract</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">nicht spezifiziert</subfield><subfield code="b">zzz</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">nicht spezifiziert</subfield><subfield code="b">z</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">nicht spezifiziert</subfield><subfield code="b">zu</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">Zhengqing Fengtongning injection is the sterile aqueous solution of Sinomenine Hydrochloride extracted from the root and stem of Sinomenium acutum, and is widely used to treat rheumatoid arthritis. Due to the processes of extraction, separation, purification, preparation and storage, some related impurities might be formed, which may cause side effects on patients. It is important to rapidly separate and identify the related impurities to ensure the safe use of Zhengqing Fengtongning injection. However, there are few literatures about the impurity in Zhengqing Fengtongning injection. In this work, ultra-high performance liquid chromatography- quadrupole time-of-flight mass spectrometry (UPLC-QTOF/MS) was developed to analyze impurities in both Zhengqing Fengtongning injection and its drug substance, with Sinomenine Hydrochloride as its active pharmaceutical ingredient (API). Six impurities of the Zhengqing Fengtongning injection were found. Structures of impurities 1 and 6 were confirmed by NMR and other impurities were identified from the fragmentation pattern of Sinomenine, the similarity of molecular weight and fragment ions in references. Finally, the HPLC analytical technique was developed to achieve the quantification of impurities 1 and 6. In addition, some reasonable suggestions are put forward on the quality control of Zhengqing Fengtongning injection and its drug substance based on the processes and structural characteristics of the related substances. The technical system established in this paper is helpful to strengthen the quality control of Zhengqing Fengtongning injection and improve production, and can also provide references for the production and quality control of similar drugs.</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">Zhengqing Fengtongning injection is the sterile aqueous solution of Sinomenine Hydrochloride extracted from the root and stem of Sinomenium acutum, and is widely used to treat rheumatoid arthritis. Due to the processes of extraction, separation, purification, preparation and storage, some related impurities might be formed, which may cause side effects on patients. It is important to rapidly separate and identify the related impurities to ensure the safe use of Zhengqing Fengtongning injection. However, there are few literatures about the impurity in Zhengqing Fengtongning injection. In this work, ultra-high performance liquid chromatography- quadrupole time-of-flight mass spectrometry (UPLC-QTOF/MS) was developed to analyze impurities in both Zhengqing Fengtongning injection and its drug substance, with Sinomenine Hydrochloride as its active pharmaceutical ingredient (API). Six impurities of the Zhengqing Fengtongning injection were found. Structures of impurities 1 and 6 were confirmed by NMR and other impurities were identified from the fragmentation pattern of Sinomenine, the similarity of molecular weight and fragment ions in references. Finally, the HPLC analytical technique was developed to achieve the quantification of impurities 1 and 6. In addition, some reasonable suggestions are put forward on the quality control of Zhengqing Fengtongning injection and its drug substance based on the processes and structural characteristics of the related substances. The technical system established in this paper is helpful to strengthen the quality control of Zhengqing Fengtongning injection and improve production, and can also provide references for the production and quality control of similar drugs.</subfield></datafield><datafield tag="650" ind1=" " ind2="7"><subfield code="a">Impurity</subfield><subfield code="2">Elsevier</subfield></datafield><datafield tag="650" ind1=" " ind2="7"><subfield code="a">Zhengqing Fengtongning injection</subfield><subfield code="2">Elsevier</subfield></datafield><datafield tag="650" ind1=" " ind2="7"><subfield code="a">Sinomenine Hydrochloride</subfield><subfield code="2">Elsevier</subfield></datafield><datafield tag="650" ind1=" " ind2="7"><subfield code="a">Quality control</subfield><subfield code="2">Elsevier</subfield></datafield><datafield tag="650" ind1=" " ind2="7"><subfield code="a">UPLC-QTOF/MS</subfield><subfield code="2">Elsevier</subfield></datafield><datafield tag="650" ind1=" " ind2="7"><subfield code="a">Identification</subfield><subfield code="2">Elsevier</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Peng, Le</subfield><subfield code="4">oth</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Wu, Honggen</subfield><subfield code="4">oth</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Jia, Chaoliang</subfield><subfield code="4">oth</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Zhu, Yongbo</subfield><subfield code="4">oth</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Qiu, Ping</subfield><subfield code="4">oth</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Tu, Pengfei</subfield><subfield code="4">oth</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Li, Zheng</subfield><subfield code="4">oth</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Li, Wenlong</subfield><subfield code="4">oth</subfield></datafield><datafield tag="773" ind1="0" ind2="8"><subfield code="i">Enthalten in</subfield><subfield code="n">Science Direct</subfield><subfield code="a">Gölbaşι, Gülcan ELSEVIER</subfield><subfield code="t">Monitoring the changes in physicochemical, sensory properties and microbiota of village-type homemade yoghurts along three consecutive back-slopping procedures</subfield><subfield code="d">2023</subfield><subfield code="d">the official analytical journal of the American Association of Pharmaceutical Scientists</subfield><subfield code="g">New York, NY [u.a.]</subfield><subfield code="w">(DE-627)ELV009872493</subfield></datafield><datafield tag="773" ind1="1" ind2="8"><subfield code="g">volume:219</subfield><subfield code="g">year:2022</subfield><subfield code="g">day:20</subfield><subfield code="g">month:09</subfield><subfield code="g">pages:0</subfield></datafield><datafield tag="856" ind1="4" ind2="0"><subfield code="u">https://doi.org/10.1016/j.jpba.2022.114970</subfield><subfield code="3">Volltext</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_USEFLAG_U</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ELV</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">SYSFLAG_U</subfield></datafield><datafield tag="936" ind1="b" ind2="k"><subfield code="a">58.34</subfield><subfield code="j">Lebensmitteltechnologie</subfield><subfield code="q">VZ</subfield></datafield><datafield tag="936" ind1="b" ind2="k"><subfield code="a">48.61</subfield><subfield code="j">Tierernährung</subfield><subfield code="j">Tierfutter</subfield><subfield code="q">VZ</subfield></datafield><datafield tag="951" ind1=" " ind2=" "><subfield code="a">AR</subfield></datafield><datafield tag="952" ind1=" " ind2=" "><subfield code="d">219</subfield><subfield code="j">2022</subfield><subfield code="b">20</subfield><subfield code="c">0920</subfield><subfield code="h">0</subfield></datafield></record></collection>
|
| score |
7.401865 |