Critical review on establishment and availability of impurity and degradation product reference standards, challenges faced by the users, recent developments, and trends
The reference standards of impurities (IMPs) and degradation products (DPs) are required by pharmaceutical industry and quality testing laboratories the world over to comply with stringent thresholds prescribed in the compendial tests. In all the major pharmacopoeias, more and more monographs are cu...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
Singh, Dilip Kumar [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2018transfer abstract |
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| Schlagwörter: |
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| Umfang: |
23 |
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| Übergeordnetes Werk: |
Enthalten in: The effect of increasing Body Mass Index on sperm quality of subfertile men - Kozopas, N. ELSEVIER, 2019, TrAC, Amsterdam |
|---|---|
| Übergeordnetes Werk: |
volume:101 ; year:2018 ; pages:85-107 ; extent:23 |
| Links: |
|---|
| DOI / URN: |
10.1016/j.trac.2017.10.021 |
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| 520 | |a The reference standards of impurities (IMPs) and degradation products (DPs) are required by pharmaceutical industry and quality testing laboratories the world over to comply with stringent thresholds prescribed in the compendial tests. In all the major pharmacopoeias, more and more monographs are currently being modified to include tests for IMPs and DPs. This review does a critical analysis of the whole situation with respect to development, supply, costs, etc. of reference standards of IMPs and DPs. It is found that significant differences exist not only regarding these aspects, but even the definitions, nomenclatures, types, instructions for use, storage, handling, etc. Typical suggestions have been put forth, which may prove handy to Pharmacopoeial Discussion Group and the pharmacopoeial agencies during harmonization exercise. The write-up also discusses difficulties faced by the users, recent developments and the trends. | ||
| 520 | |a The reference standards of impurities (IMPs) and degradation products (DPs) are required by pharmaceutical industry and quality testing laboratories the world over to comply with stringent thresholds prescribed in the compendial tests. In all the major pharmacopoeias, more and more monographs are currently being modified to include tests for IMPs and DPs. This review does a critical analysis of the whole situation with respect to development, supply, costs, etc. of reference standards of IMPs and DPs. It is found that significant differences exist not only regarding these aspects, but even the definitions, nomenclatures, types, instructions for use, storage, handling, etc. Typical suggestions have been put forth, which may prove handy to Pharmacopoeial Discussion Group and the pharmacopoeial agencies during harmonization exercise. The write-up also discusses difficulties faced by the users, recent developments and the trends. | ||
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10.1016/j.trac.2017.10.021 doi GBV00000000000179A.pica (DE-627)ELV042498104 (ELSEVIER)S0165-9936(17)30371-0 DE-627 ger DE-627 rakwb eng 540 540 DE-600 540 610 VZ 35.00 bkl 44.46 bkl Singh, Dilip Kumar verfasserin aut Critical review on establishment and availability of impurity and degradation product reference standards, challenges faced by the users, recent developments, and trends 2018transfer abstract 23 nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier The reference standards of impurities (IMPs) and degradation products (DPs) are required by pharmaceutical industry and quality testing laboratories the world over to comply with stringent thresholds prescribed in the compendial tests. In all the major pharmacopoeias, more and more monographs are currently being modified to include tests for IMPs and DPs. This review does a critical analysis of the whole situation with respect to development, supply, costs, etc. of reference standards of IMPs and DPs. It is found that significant differences exist not only regarding these aspects, but even the definitions, nomenclatures, types, instructions for use, storage, handling, etc. Typical suggestions have been put forth, which may prove handy to Pharmacopoeial Discussion Group and the pharmacopoeial agencies during harmonization exercise. The write-up also discusses difficulties faced by the users, recent developments and the trends. The reference standards of impurities (IMPs) and degradation products (DPs) are required by pharmaceutical industry and quality testing laboratories the world over to comply with stringent thresholds prescribed in the compendial tests. In all the major pharmacopoeias, more and more monographs are currently being modified to include tests for IMPs and DPs. This review does a critical analysis of the whole situation with respect to development, supply, costs, etc. of reference standards of IMPs and DPs. It is found that significant differences exist not only regarding these aspects, but even the definitions, nomenclatures, types, instructions for use, storage, handling, etc. Typical suggestions have been put forth, which may prove handy to Pharmacopoeial Discussion Group and the pharmacopoeial agencies during harmonization exercise. The write-up also discusses difficulties faced by the users, recent developments and the trends. Reference standards Elsevier Primary reference standards Elsevier Degradation products Elsevier Impurities Elsevier International chemical reference substances Elsevier Secondary reference standards Elsevier Pharmacopoeial standards Elsevier Working standards Elsevier Sahu, Archana oth Kumar, Sanjay oth Singh, Saranjit oth Enthalten in Elsevier Kozopas, N. ELSEVIER The effect of increasing Body Mass Index on sperm quality of subfertile men 2019 TrAC Amsterdam (DE-627)ELV002244268 volume:101 year:2018 pages:85-107 extent:23 https://doi.org/10.1016/j.trac.2017.10.021 Volltext GBV_USEFLAG_U GBV_ELV SYSFLAG_U SSG-OLC-PHA 35.00 Chemie: Allgemeines VZ 44.46 Klinische Pathologie VZ AR 101 2018 85-107 23 045F 540 |
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10.1016/j.trac.2017.10.021 doi GBV00000000000179A.pica (DE-627)ELV042498104 (ELSEVIER)S0165-9936(17)30371-0 DE-627 ger DE-627 rakwb eng 540 540 DE-600 540 610 VZ 35.00 bkl 44.46 bkl Singh, Dilip Kumar verfasserin aut Critical review on establishment and availability of impurity and degradation product reference standards, challenges faced by the users, recent developments, and trends 2018transfer abstract 23 nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier The reference standards of impurities (IMPs) and degradation products (DPs) are required by pharmaceutical industry and quality testing laboratories the world over to comply with stringent thresholds prescribed in the compendial tests. In all the major pharmacopoeias, more and more monographs are currently being modified to include tests for IMPs and DPs. This review does a critical analysis of the whole situation with respect to development, supply, costs, etc. of reference standards of IMPs and DPs. It is found that significant differences exist not only regarding these aspects, but even the definitions, nomenclatures, types, instructions for use, storage, handling, etc. Typical suggestions have been put forth, which may prove handy to Pharmacopoeial Discussion Group and the pharmacopoeial agencies during harmonization exercise. The write-up also discusses difficulties faced by the users, recent developments and the trends. The reference standards of impurities (IMPs) and degradation products (DPs) are required by pharmaceutical industry and quality testing laboratories the world over to comply with stringent thresholds prescribed in the compendial tests. In all the major pharmacopoeias, more and more monographs are currently being modified to include tests for IMPs and DPs. This review does a critical analysis of the whole situation with respect to development, supply, costs, etc. of reference standards of IMPs and DPs. It is found that significant differences exist not only regarding these aspects, but even the definitions, nomenclatures, types, instructions for use, storage, handling, etc. Typical suggestions have been put forth, which may prove handy to Pharmacopoeial Discussion Group and the pharmacopoeial agencies during harmonization exercise. The write-up also discusses difficulties faced by the users, recent developments and the trends. Reference standards Elsevier Primary reference standards Elsevier Degradation products Elsevier Impurities Elsevier International chemical reference substances Elsevier Secondary reference standards Elsevier Pharmacopoeial standards Elsevier Working standards Elsevier Sahu, Archana oth Kumar, Sanjay oth Singh, Saranjit oth Enthalten in Elsevier Kozopas, N. ELSEVIER The effect of increasing Body Mass Index on sperm quality of subfertile men 2019 TrAC Amsterdam (DE-627)ELV002244268 volume:101 year:2018 pages:85-107 extent:23 https://doi.org/10.1016/j.trac.2017.10.021 Volltext GBV_USEFLAG_U GBV_ELV SYSFLAG_U SSG-OLC-PHA 35.00 Chemie: Allgemeines VZ 44.46 Klinische Pathologie VZ AR 101 2018 85-107 23 045F 540 |
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10.1016/j.trac.2017.10.021 doi GBV00000000000179A.pica (DE-627)ELV042498104 (ELSEVIER)S0165-9936(17)30371-0 DE-627 ger DE-627 rakwb eng 540 540 DE-600 540 610 VZ 35.00 bkl 44.46 bkl Singh, Dilip Kumar verfasserin aut Critical review on establishment and availability of impurity and degradation product reference standards, challenges faced by the users, recent developments, and trends 2018transfer abstract 23 nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier The reference standards of impurities (IMPs) and degradation products (DPs) are required by pharmaceutical industry and quality testing laboratories the world over to comply with stringent thresholds prescribed in the compendial tests. In all the major pharmacopoeias, more and more monographs are currently being modified to include tests for IMPs and DPs. This review does a critical analysis of the whole situation with respect to development, supply, costs, etc. of reference standards of IMPs and DPs. It is found that significant differences exist not only regarding these aspects, but even the definitions, nomenclatures, types, instructions for use, storage, handling, etc. Typical suggestions have been put forth, which may prove handy to Pharmacopoeial Discussion Group and the pharmacopoeial agencies during harmonization exercise. The write-up also discusses difficulties faced by the users, recent developments and the trends. The reference standards of impurities (IMPs) and degradation products (DPs) are required by pharmaceutical industry and quality testing laboratories the world over to comply with stringent thresholds prescribed in the compendial tests. In all the major pharmacopoeias, more and more monographs are currently being modified to include tests for IMPs and DPs. This review does a critical analysis of the whole situation with respect to development, supply, costs, etc. of reference standards of IMPs and DPs. It is found that significant differences exist not only regarding these aspects, but even the definitions, nomenclatures, types, instructions for use, storage, handling, etc. Typical suggestions have been put forth, which may prove handy to Pharmacopoeial Discussion Group and the pharmacopoeial agencies during harmonization exercise. The write-up also discusses difficulties faced by the users, recent developments and the trends. Reference standards Elsevier Primary reference standards Elsevier Degradation products Elsevier Impurities Elsevier International chemical reference substances Elsevier Secondary reference standards Elsevier Pharmacopoeial standards Elsevier Working standards Elsevier Sahu, Archana oth Kumar, Sanjay oth Singh, Saranjit oth Enthalten in Elsevier Kozopas, N. ELSEVIER The effect of increasing Body Mass Index on sperm quality of subfertile men 2019 TrAC Amsterdam (DE-627)ELV002244268 volume:101 year:2018 pages:85-107 extent:23 https://doi.org/10.1016/j.trac.2017.10.021 Volltext GBV_USEFLAG_U GBV_ELV SYSFLAG_U SSG-OLC-PHA 35.00 Chemie: Allgemeines VZ 44.46 Klinische Pathologie VZ AR 101 2018 85-107 23 045F 540 |
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10.1016/j.trac.2017.10.021 doi GBV00000000000179A.pica (DE-627)ELV042498104 (ELSEVIER)S0165-9936(17)30371-0 DE-627 ger DE-627 rakwb eng 540 540 DE-600 540 610 VZ 35.00 bkl 44.46 bkl Singh, Dilip Kumar verfasserin aut Critical review on establishment and availability of impurity and degradation product reference standards, challenges faced by the users, recent developments, and trends 2018transfer abstract 23 nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier The reference standards of impurities (IMPs) and degradation products (DPs) are required by pharmaceutical industry and quality testing laboratories the world over to comply with stringent thresholds prescribed in the compendial tests. In all the major pharmacopoeias, more and more monographs are currently being modified to include tests for IMPs and DPs. This review does a critical analysis of the whole situation with respect to development, supply, costs, etc. of reference standards of IMPs and DPs. It is found that significant differences exist not only regarding these aspects, but even the definitions, nomenclatures, types, instructions for use, storage, handling, etc. Typical suggestions have been put forth, which may prove handy to Pharmacopoeial Discussion Group and the pharmacopoeial agencies during harmonization exercise. The write-up also discusses difficulties faced by the users, recent developments and the trends. The reference standards of impurities (IMPs) and degradation products (DPs) are required by pharmaceutical industry and quality testing laboratories the world over to comply with stringent thresholds prescribed in the compendial tests. In all the major pharmacopoeias, more and more monographs are currently being modified to include tests for IMPs and DPs. This review does a critical analysis of the whole situation with respect to development, supply, costs, etc. of reference standards of IMPs and DPs. It is found that significant differences exist not only regarding these aspects, but even the definitions, nomenclatures, types, instructions for use, storage, handling, etc. Typical suggestions have been put forth, which may prove handy to Pharmacopoeial Discussion Group and the pharmacopoeial agencies during harmonization exercise. The write-up also discusses difficulties faced by the users, recent developments and the trends. Reference standards Elsevier Primary reference standards Elsevier Degradation products Elsevier Impurities Elsevier International chemical reference substances Elsevier Secondary reference standards Elsevier Pharmacopoeial standards Elsevier Working standards Elsevier Sahu, Archana oth Kumar, Sanjay oth Singh, Saranjit oth Enthalten in Elsevier Kozopas, N. ELSEVIER The effect of increasing Body Mass Index on sperm quality of subfertile men 2019 TrAC Amsterdam (DE-627)ELV002244268 volume:101 year:2018 pages:85-107 extent:23 https://doi.org/10.1016/j.trac.2017.10.021 Volltext GBV_USEFLAG_U GBV_ELV SYSFLAG_U SSG-OLC-PHA 35.00 Chemie: Allgemeines VZ 44.46 Klinische Pathologie VZ AR 101 2018 85-107 23 045F 540 |
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10.1016/j.trac.2017.10.021 doi GBV00000000000179A.pica (DE-627)ELV042498104 (ELSEVIER)S0165-9936(17)30371-0 DE-627 ger DE-627 rakwb eng 540 540 DE-600 540 610 VZ 35.00 bkl 44.46 bkl Singh, Dilip Kumar verfasserin aut Critical review on establishment and availability of impurity and degradation product reference standards, challenges faced by the users, recent developments, and trends 2018transfer abstract 23 nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier The reference standards of impurities (IMPs) and degradation products (DPs) are required by pharmaceutical industry and quality testing laboratories the world over to comply with stringent thresholds prescribed in the compendial tests. In all the major pharmacopoeias, more and more monographs are currently being modified to include tests for IMPs and DPs. This review does a critical analysis of the whole situation with respect to development, supply, costs, etc. of reference standards of IMPs and DPs. It is found that significant differences exist not only regarding these aspects, but even the definitions, nomenclatures, types, instructions for use, storage, handling, etc. Typical suggestions have been put forth, which may prove handy to Pharmacopoeial Discussion Group and the pharmacopoeial agencies during harmonization exercise. The write-up also discusses difficulties faced by the users, recent developments and the trends. The reference standards of impurities (IMPs) and degradation products (DPs) are required by pharmaceutical industry and quality testing laboratories the world over to comply with stringent thresholds prescribed in the compendial tests. In all the major pharmacopoeias, more and more monographs are currently being modified to include tests for IMPs and DPs. This review does a critical analysis of the whole situation with respect to development, supply, costs, etc. of reference standards of IMPs and DPs. It is found that significant differences exist not only regarding these aspects, but even the definitions, nomenclatures, types, instructions for use, storage, handling, etc. Typical suggestions have been put forth, which may prove handy to Pharmacopoeial Discussion Group and the pharmacopoeial agencies during harmonization exercise. The write-up also discusses difficulties faced by the users, recent developments and the trends. Reference standards Elsevier Primary reference standards Elsevier Degradation products Elsevier Impurities Elsevier International chemical reference substances Elsevier Secondary reference standards Elsevier Pharmacopoeial standards Elsevier Working standards Elsevier Sahu, Archana oth Kumar, Sanjay oth Singh, Saranjit oth Enthalten in Elsevier Kozopas, N. ELSEVIER The effect of increasing Body Mass Index on sperm quality of subfertile men 2019 TrAC Amsterdam (DE-627)ELV002244268 volume:101 year:2018 pages:85-107 extent:23 https://doi.org/10.1016/j.trac.2017.10.021 Volltext GBV_USEFLAG_U GBV_ELV SYSFLAG_U SSG-OLC-PHA 35.00 Chemie: Allgemeines VZ 44.46 Klinische Pathologie VZ AR 101 2018 85-107 23 045F 540 |
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Critical review on establishment and availability of impurity and degradation product reference standards, challenges faced by the users, recent developments, and trends |
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The reference standards of impurities (IMPs) and degradation products (DPs) are required by pharmaceutical industry and quality testing laboratories the world over to comply with stringent thresholds prescribed in the compendial tests. In all the major pharmacopoeias, more and more monographs are currently being modified to include tests for IMPs and DPs. This review does a critical analysis of the whole situation with respect to development, supply, costs, etc. of reference standards of IMPs and DPs. It is found that significant differences exist not only regarding these aspects, but even the definitions, nomenclatures, types, instructions for use, storage, handling, etc. Typical suggestions have been put forth, which may prove handy to Pharmacopoeial Discussion Group and the pharmacopoeial agencies during harmonization exercise. The write-up also discusses difficulties faced by the users, recent developments and the trends. |
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The reference standards of impurities (IMPs) and degradation products (DPs) are required by pharmaceutical industry and quality testing laboratories the world over to comply with stringent thresholds prescribed in the compendial tests. In all the major pharmacopoeias, more and more monographs are currently being modified to include tests for IMPs and DPs. This review does a critical analysis of the whole situation with respect to development, supply, costs, etc. of reference standards of IMPs and DPs. It is found that significant differences exist not only regarding these aspects, but even the definitions, nomenclatures, types, instructions for use, storage, handling, etc. Typical suggestions have been put forth, which may prove handy to Pharmacopoeial Discussion Group and the pharmacopoeial agencies during harmonization exercise. The write-up also discusses difficulties faced by the users, recent developments and the trends. |
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The reference standards of impurities (IMPs) and degradation products (DPs) are required by pharmaceutical industry and quality testing laboratories the world over to comply with stringent thresholds prescribed in the compendial tests. In all the major pharmacopoeias, more and more monographs are currently being modified to include tests for IMPs and DPs. This review does a critical analysis of the whole situation with respect to development, supply, costs, etc. of reference standards of IMPs and DPs. It is found that significant differences exist not only regarding these aspects, but even the definitions, nomenclatures, types, instructions for use, storage, handling, etc. Typical suggestions have been put forth, which may prove handy to Pharmacopoeial Discussion Group and the pharmacopoeial agencies during harmonization exercise. The write-up also discusses difficulties faced by the users, recent developments and the trends. |
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