First inter-laboratory study of a Supercritical Fluid Chromatography method for the determination of pharmaceutical impurities
Supercritical Fluid Chromatography (SFC) has known a strong regain of interest for the last 10 years, especially in the field of pharmaceutical analysis. Besides the development and validation of the SFC method in one individual laboratory, it is also important to demonstrate its applicability and t...
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2018 |
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Enthalten in: Journal of pharmaceutical and biomedical analysis - New York, NY [u.a.] : Science Direct, 1983, 161, Seite 414-424 |
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| Übergeordnetes Werk: |
volume:161 ; pages:414-424 |
| DOI / URN: |
10.1016/j.jpba.2018.08.042 |
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ELV000805505 |
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| 245 | 1 | 0 | |a First inter-laboratory study of a Supercritical Fluid Chromatography method for the determination of pharmaceutical impurities |
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| 520 | |a Supercritical Fluid Chromatography (SFC) has known a strong regain of interest for the last 10 years, especially in the field of pharmaceutical analysis. Besides the development and validation of the SFC method in one individual laboratory, it is also important to demonstrate its applicability and transferability to various laboratories around the world. Therefore, an inter-laboratory study was conducted and published for the first time in SFC, to assess method reproducibility, and evaluate whether this chromatographic technique could become a reference method for quality control (QC) laboratories. This study involved 19 participating laboratories from 4 continents and 9 different countries. It included 5 academic groups, 3 demonstration laboratories at analytical instrument companies, 10 pharmaceutical companies and 1 food company. In the initial analysis of the study results, consistencies within- and between-laboratories were deeply examined. In the subsequent analysis, the method reproducibility was estimated taking into account variances in replicates, between-days and between-laboratories. The results obtained were compared with the literature values for liquid chromatography (LC) in the context of impurities determination. Repeatability and reproducibility variances were found to be similar or better than those described for LC methods, and highlighted the adequacy of the SFC method for QC analyses. The results demonstrated the excellent and robust quantitative performance of SFC. Consequently, this complementary technique is recognized on equal merit to other chromatographic techniques. | ||
| 650 | 4 | |a Supercritical Fluid Chromatography (SFC) | |
| 650 | 4 | |a Inter-laboratory study | |
| 650 | 4 | |a Collaborative study | |
| 650 | 4 | |a Reproducibility | |
| 650 | 4 | |a Pharmaceutical impurities | |
| 650 | 4 | |a Salbutamol sulfate | |
| 700 | 1 | |a Marini, Roland |e verfasserin |4 aut | |
| 700 | 1 | |a Desfontaine, Vincent |e verfasserin |4 aut | |
| 700 | 1 | |a Veuthey, Jean-Luc |e verfasserin |4 aut | |
| 700 | 1 | |a Kotoni, Dorina |e verfasserin |0 (orcid)0000-0002-5847-2233 |4 aut | |
| 700 | 1 | |a Losacco, Luca Gioacchino |e verfasserin |4 aut | |
| 700 | 1 | |a Clarke, Adrian |e verfasserin |4 aut | |
| 700 | 1 | |a Muscat Galea, Charlene |e verfasserin |4 aut | |
| 700 | 1 | |a Mangelings, Debby |e verfasserin |4 aut | |
| 700 | 1 | |a Jocher, Brandon M. |e verfasserin |4 aut | |
| 700 | 1 | |a Regalado, Erik L. |e verfasserin |0 (orcid)0000-0002-7352-6391 |4 aut | |
| 700 | 1 | |a Plachká, Katerina |e verfasserin |0 (orcid)0000-0001-9655-9199 |4 aut | |
| 700 | 1 | |a Nováková, Lucie |e verfasserin |4 aut | |
| 700 | 1 | |a Wuyts, Benjamin |e verfasserin |4 aut | |
| 700 | 1 | |a François, Isabelle |e verfasserin |4 aut | |
| 700 | 1 | |a Gray, Michael |e verfasserin |4 aut | |
| 700 | 1 | |a Aubin, Andrew J. |e verfasserin |4 aut | |
| 700 | 1 | |a Tarafder, Abhijit |e verfasserin |4 aut | |
| 700 | 1 | |a Cazes, Maxime |e verfasserin |4 aut | |
| 700 | 1 | |a Desvignes, Christophe |e verfasserin |4 aut | |
| 700 | 1 | |a Villemet, Loic |e verfasserin |4 aut | |
| 700 | 1 | |a Sarrut, Morgan |e verfasserin |4 aut | |
| 700 | 1 | |a Raimbault, Adrien |e verfasserin |4 aut | |
| 700 | 1 | |a Lemasson, Elise |e verfasserin |4 aut | |
| 700 | 1 | |a Lesellier, Eric |e verfasserin |4 aut | |
| 700 | 1 | |a West, Caroline |e verfasserin |0 (orcid)0000-0001-7595-6777 |4 aut | |
| 700 | 1 | |a Leek, Tomas |e verfasserin |4 aut | |
| 700 | 1 | |a Wong, Mengling |e verfasserin |4 aut | |
| 700 | 1 | |a Dai, Lulu |e verfasserin |4 aut | |
| 700 | 1 | |a Zhang, Kelly |e verfasserin |0 (orcid)0000-0001-6515-544X |4 aut | |
| 700 | 1 | |a Grand-Guillaume Perrenoud, Alexandre |e verfasserin |4 aut | |
| 700 | 1 | |a Brunelli, Claudio |e verfasserin |4 aut | |
| 700 | 1 | |a Hennig, Philippe |e verfasserin |4 aut | |
| 700 | 1 | |a Bertin, Sophie |e verfasserin |4 aut | |
| 700 | 1 | |a Mauge, Fabien |e verfasserin |4 aut | |
| 700 | 1 | |a Da Costa, Nathalie |e verfasserin |4 aut | |
| 700 | 1 | |a Farrell, William P. |e verfasserin |0 (orcid)0000-0002-3341-9831 |4 aut | |
| 700 | 1 | |a Hill, Madeleine |e verfasserin |4 aut | |
| 700 | 1 | |a Desphande, Niranjan |e verfasserin |0 (orcid)0000-0002-8548-2242 |4 aut | |
| 700 | 1 | |a Grangrade, Manish |e verfasserin |4 aut | |
| 700 | 1 | |a Sadaphule, Santosh |e verfasserin |4 aut | |
| 700 | 1 | |a Yadav, Ravi |e verfasserin |4 aut | |
| 700 | 1 | |a Rane, Sandesh |e verfasserin |4 aut | |
| 700 | 1 | |a Shringare, Shankar |e verfasserin |4 aut | |
| 700 | 1 | |a Iguiniz, Marion |e verfasserin |4 aut | |
| 700 | 1 | |a Heinisch, Sabine |e verfasserin |4 aut | |
| 700 | 1 | |a Lefevre, Julien |e verfasserin |4 aut | |
| 700 | 1 | |a Corbel, Estelle |e verfasserin |4 aut | |
| 700 | 1 | |a Roques, Nicolas |e verfasserin |4 aut | |
| 700 | 1 | |a Heyden, Yvan Vander |e verfasserin |4 aut | |
| 700 | 1 | |a Guillarme, Davy |e verfasserin |4 aut | |
| 700 | 1 | |a Hubert, Philippe |e verfasserin |4 aut | |
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10.1016/j.jpba.2018.08.042 doi (DE-627)ELV000805505 (ELSEVIER)S0731-7085(18)31547-4 DE-627 ger DE-627 rda eng 610 DE-600 15,3 ssgn PHARM DE-84 fid 44.40 bkl Dispas, Amandine verfasserin aut First inter-laboratory study of a Supercritical Fluid Chromatography method for the determination of pharmaceutical impurities 2018 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Supercritical Fluid Chromatography (SFC) has known a strong regain of interest for the last 10 years, especially in the field of pharmaceutical analysis. Besides the development and validation of the SFC method in one individual laboratory, it is also important to demonstrate its applicability and transferability to various laboratories around the world. Therefore, an inter-laboratory study was conducted and published for the first time in SFC, to assess method reproducibility, and evaluate whether this chromatographic technique could become a reference method for quality control (QC) laboratories. This study involved 19 participating laboratories from 4 continents and 9 different countries. It included 5 academic groups, 3 demonstration laboratories at analytical instrument companies, 10 pharmaceutical companies and 1 food company. In the initial analysis of the study results, consistencies within- and between-laboratories were deeply examined. In the subsequent analysis, the method reproducibility was estimated taking into account variances in replicates, between-days and between-laboratories. The results obtained were compared with the literature values for liquid chromatography (LC) in the context of impurities determination. Repeatability and reproducibility variances were found to be similar or better than those described for LC methods, and highlighted the adequacy of the SFC method for QC analyses. The results demonstrated the excellent and robust quantitative performance of SFC. Consequently, this complementary technique is recognized on equal merit to other chromatographic techniques. Supercritical Fluid Chromatography (SFC) Inter-laboratory study Collaborative study Reproducibility Pharmaceutical impurities Salbutamol sulfate Marini, Roland verfasserin aut Desfontaine, Vincent verfasserin aut Veuthey, Jean-Luc verfasserin aut Kotoni, Dorina verfasserin (orcid)0000-0002-5847-2233 aut Losacco, Luca Gioacchino verfasserin aut Clarke, Adrian verfasserin aut Muscat Galea, Charlene verfasserin aut Mangelings, Debby verfasserin aut Jocher, Brandon M. verfasserin aut Regalado, Erik L. verfasserin (orcid)0000-0002-7352-6391 aut Plachká, Katerina verfasserin (orcid)0000-0001-9655-9199 aut Nováková, Lucie verfasserin aut Wuyts, Benjamin verfasserin aut François, Isabelle verfasserin aut Gray, Michael verfasserin aut Aubin, Andrew J. verfasserin aut Tarafder, Abhijit verfasserin aut Cazes, Maxime verfasserin aut Desvignes, Christophe verfasserin aut Villemet, Loic verfasserin aut Sarrut, Morgan verfasserin aut Raimbault, Adrien verfasserin aut Lemasson, Elise verfasserin aut Lesellier, Eric verfasserin aut West, Caroline verfasserin (orcid)0000-0001-7595-6777 aut Leek, Tomas verfasserin aut Wong, Mengling verfasserin aut Dai, Lulu verfasserin aut Zhang, Kelly verfasserin (orcid)0000-0001-6515-544X aut Grand-Guillaume Perrenoud, Alexandre verfasserin aut Brunelli, Claudio verfasserin aut Hennig, Philippe verfasserin aut Bertin, Sophie verfasserin aut Mauge, Fabien verfasserin aut Da Costa, Nathalie verfasserin aut Farrell, William P. verfasserin (orcid)0000-0002-3341-9831 aut Hill, Madeleine verfasserin aut Desphande, Niranjan verfasserin (orcid)0000-0002-8548-2242 aut Grangrade, Manish verfasserin aut Sadaphule, Santosh verfasserin aut Yadav, Ravi verfasserin aut Rane, Sandesh verfasserin aut Shringare, Shankar verfasserin aut Iguiniz, Marion verfasserin aut Heinisch, Sabine verfasserin aut Lefevre, Julien verfasserin aut Corbel, Estelle verfasserin aut Roques, Nicolas verfasserin aut Heyden, Yvan Vander verfasserin aut Guillarme, Davy verfasserin aut Hubert, Philippe verfasserin aut Enthalten in Journal of pharmaceutical and biomedical analysis New York, NY [u.a.] : Science Direct, 1983 161, Seite 414-424 Online-Ressource (DE-627)30271801X (DE-600)1491820-1 (DE-576)259483931 1873-264X nnns volume:161 pages:414-424 GBV_USEFLAG_U SYSFLAG_U GBV_ELV FID-PHARM SSG-OLC-PHA SSG-OPC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_150 GBV_ILN_151 GBV_ILN_224 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2034 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2064 GBV_ILN_2068 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2143 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2336 GBV_ILN_4037 GBV_ILN_4242 GBV_ILN_4251 GBV_ILN_4313 GBV_ILN_4326 GBV_ILN_4334 GBV_ILN_4338 44.40 Pharmazie Pharmazeutika AR 161 414-424 |
| spelling |
10.1016/j.jpba.2018.08.042 doi (DE-627)ELV000805505 (ELSEVIER)S0731-7085(18)31547-4 DE-627 ger DE-627 rda eng 610 DE-600 15,3 ssgn PHARM DE-84 fid 44.40 bkl Dispas, Amandine verfasserin aut First inter-laboratory study of a Supercritical Fluid Chromatography method for the determination of pharmaceutical impurities 2018 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Supercritical Fluid Chromatography (SFC) has known a strong regain of interest for the last 10 years, especially in the field of pharmaceutical analysis. Besides the development and validation of the SFC method in one individual laboratory, it is also important to demonstrate its applicability and transferability to various laboratories around the world. Therefore, an inter-laboratory study was conducted and published for the first time in SFC, to assess method reproducibility, and evaluate whether this chromatographic technique could become a reference method for quality control (QC) laboratories. This study involved 19 participating laboratories from 4 continents and 9 different countries. It included 5 academic groups, 3 demonstration laboratories at analytical instrument companies, 10 pharmaceutical companies and 1 food company. In the initial analysis of the study results, consistencies within- and between-laboratories were deeply examined. In the subsequent analysis, the method reproducibility was estimated taking into account variances in replicates, between-days and between-laboratories. The results obtained were compared with the literature values for liquid chromatography (LC) in the context of impurities determination. Repeatability and reproducibility variances were found to be similar or better than those described for LC methods, and highlighted the adequacy of the SFC method for QC analyses. The results demonstrated the excellent and robust quantitative performance of SFC. Consequently, this complementary technique is recognized on equal merit to other chromatographic techniques. Supercritical Fluid Chromatography (SFC) Inter-laboratory study Collaborative study Reproducibility Pharmaceutical impurities Salbutamol sulfate Marini, Roland verfasserin aut Desfontaine, Vincent verfasserin aut Veuthey, Jean-Luc verfasserin aut Kotoni, Dorina verfasserin (orcid)0000-0002-5847-2233 aut Losacco, Luca Gioacchino verfasserin aut Clarke, Adrian verfasserin aut Muscat Galea, Charlene verfasserin aut Mangelings, Debby verfasserin aut Jocher, Brandon M. verfasserin aut Regalado, Erik L. verfasserin (orcid)0000-0002-7352-6391 aut Plachká, Katerina verfasserin (orcid)0000-0001-9655-9199 aut Nováková, Lucie verfasserin aut Wuyts, Benjamin verfasserin aut François, Isabelle verfasserin aut Gray, Michael verfasserin aut Aubin, Andrew J. verfasserin aut Tarafder, Abhijit verfasserin aut Cazes, Maxime verfasserin aut Desvignes, Christophe verfasserin aut Villemet, Loic verfasserin aut Sarrut, Morgan verfasserin aut Raimbault, Adrien verfasserin aut Lemasson, Elise verfasserin aut Lesellier, Eric verfasserin aut West, Caroline verfasserin (orcid)0000-0001-7595-6777 aut Leek, Tomas verfasserin aut Wong, Mengling verfasserin aut Dai, Lulu verfasserin aut Zhang, Kelly verfasserin (orcid)0000-0001-6515-544X aut Grand-Guillaume Perrenoud, Alexandre verfasserin aut Brunelli, Claudio verfasserin aut Hennig, Philippe verfasserin aut Bertin, Sophie verfasserin aut Mauge, Fabien verfasserin aut Da Costa, Nathalie verfasserin aut Farrell, William P. verfasserin (orcid)0000-0002-3341-9831 aut Hill, Madeleine verfasserin aut Desphande, Niranjan verfasserin (orcid)0000-0002-8548-2242 aut Grangrade, Manish verfasserin aut Sadaphule, Santosh verfasserin aut Yadav, Ravi verfasserin aut Rane, Sandesh verfasserin aut Shringare, Shankar verfasserin aut Iguiniz, Marion verfasserin aut Heinisch, Sabine verfasserin aut Lefevre, Julien verfasserin aut Corbel, Estelle verfasserin aut Roques, Nicolas verfasserin aut Heyden, Yvan Vander verfasserin aut Guillarme, Davy verfasserin aut Hubert, Philippe verfasserin aut Enthalten in Journal of pharmaceutical and biomedical analysis New York, NY [u.a.] : Science Direct, 1983 161, Seite 414-424 Online-Ressource (DE-627)30271801X (DE-600)1491820-1 (DE-576)259483931 1873-264X nnns volume:161 pages:414-424 GBV_USEFLAG_U SYSFLAG_U GBV_ELV FID-PHARM SSG-OLC-PHA SSG-OPC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_150 GBV_ILN_151 GBV_ILN_224 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2034 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2064 GBV_ILN_2068 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2143 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2336 GBV_ILN_4037 GBV_ILN_4242 GBV_ILN_4251 GBV_ILN_4313 GBV_ILN_4326 GBV_ILN_4334 GBV_ILN_4338 44.40 Pharmazie Pharmazeutika AR 161 414-424 |
| allfields_unstemmed |
10.1016/j.jpba.2018.08.042 doi (DE-627)ELV000805505 (ELSEVIER)S0731-7085(18)31547-4 DE-627 ger DE-627 rda eng 610 DE-600 15,3 ssgn PHARM DE-84 fid 44.40 bkl Dispas, Amandine verfasserin aut First inter-laboratory study of a Supercritical Fluid Chromatography method for the determination of pharmaceutical impurities 2018 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Supercritical Fluid Chromatography (SFC) has known a strong regain of interest for the last 10 years, especially in the field of pharmaceutical analysis. Besides the development and validation of the SFC method in one individual laboratory, it is also important to demonstrate its applicability and transferability to various laboratories around the world. Therefore, an inter-laboratory study was conducted and published for the first time in SFC, to assess method reproducibility, and evaluate whether this chromatographic technique could become a reference method for quality control (QC) laboratories. This study involved 19 participating laboratories from 4 continents and 9 different countries. It included 5 academic groups, 3 demonstration laboratories at analytical instrument companies, 10 pharmaceutical companies and 1 food company. In the initial analysis of the study results, consistencies within- and between-laboratories were deeply examined. In the subsequent analysis, the method reproducibility was estimated taking into account variances in replicates, between-days and between-laboratories. The results obtained were compared with the literature values for liquid chromatography (LC) in the context of impurities determination. Repeatability and reproducibility variances were found to be similar or better than those described for LC methods, and highlighted the adequacy of the SFC method for QC analyses. The results demonstrated the excellent and robust quantitative performance of SFC. Consequently, this complementary technique is recognized on equal merit to other chromatographic techniques. Supercritical Fluid Chromatography (SFC) Inter-laboratory study Collaborative study Reproducibility Pharmaceutical impurities Salbutamol sulfate Marini, Roland verfasserin aut Desfontaine, Vincent verfasserin aut Veuthey, Jean-Luc verfasserin aut Kotoni, Dorina verfasserin (orcid)0000-0002-5847-2233 aut Losacco, Luca Gioacchino verfasserin aut Clarke, Adrian verfasserin aut Muscat Galea, Charlene verfasserin aut Mangelings, Debby verfasserin aut Jocher, Brandon M. verfasserin aut Regalado, Erik L. verfasserin (orcid)0000-0002-7352-6391 aut Plachká, Katerina verfasserin (orcid)0000-0001-9655-9199 aut Nováková, Lucie verfasserin aut Wuyts, Benjamin verfasserin aut François, Isabelle verfasserin aut Gray, Michael verfasserin aut Aubin, Andrew J. verfasserin aut Tarafder, Abhijit verfasserin aut Cazes, Maxime verfasserin aut Desvignes, Christophe verfasserin aut Villemet, Loic verfasserin aut Sarrut, Morgan verfasserin aut Raimbault, Adrien verfasserin aut Lemasson, Elise verfasserin aut Lesellier, Eric verfasserin aut West, Caroline verfasserin (orcid)0000-0001-7595-6777 aut Leek, Tomas verfasserin aut Wong, Mengling verfasserin aut Dai, Lulu verfasserin aut Zhang, Kelly verfasserin (orcid)0000-0001-6515-544X aut Grand-Guillaume Perrenoud, Alexandre verfasserin aut Brunelli, Claudio verfasserin aut Hennig, Philippe verfasserin aut Bertin, Sophie verfasserin aut Mauge, Fabien verfasserin aut Da Costa, Nathalie verfasserin aut Farrell, William P. verfasserin (orcid)0000-0002-3341-9831 aut Hill, Madeleine verfasserin aut Desphande, Niranjan verfasserin (orcid)0000-0002-8548-2242 aut Grangrade, Manish verfasserin aut Sadaphule, Santosh verfasserin aut Yadav, Ravi verfasserin aut Rane, Sandesh verfasserin aut Shringare, Shankar verfasserin aut Iguiniz, Marion verfasserin aut Heinisch, Sabine verfasserin aut Lefevre, Julien verfasserin aut Corbel, Estelle verfasserin aut Roques, Nicolas verfasserin aut Heyden, Yvan Vander verfasserin aut Guillarme, Davy verfasserin aut Hubert, Philippe verfasserin aut Enthalten in Journal of pharmaceutical and biomedical analysis New York, NY [u.a.] : Science Direct, 1983 161, Seite 414-424 Online-Ressource (DE-627)30271801X (DE-600)1491820-1 (DE-576)259483931 1873-264X nnns volume:161 pages:414-424 GBV_USEFLAG_U SYSFLAG_U GBV_ELV FID-PHARM SSG-OLC-PHA SSG-OPC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_150 GBV_ILN_151 GBV_ILN_224 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2034 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2064 GBV_ILN_2068 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2143 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2336 GBV_ILN_4037 GBV_ILN_4242 GBV_ILN_4251 GBV_ILN_4313 GBV_ILN_4326 GBV_ILN_4334 GBV_ILN_4338 44.40 Pharmazie Pharmazeutika AR 161 414-424 |
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10.1016/j.jpba.2018.08.042 doi (DE-627)ELV000805505 (ELSEVIER)S0731-7085(18)31547-4 DE-627 ger DE-627 rda eng 610 DE-600 15,3 ssgn PHARM DE-84 fid 44.40 bkl Dispas, Amandine verfasserin aut First inter-laboratory study of a Supercritical Fluid Chromatography method for the determination of pharmaceutical impurities 2018 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Supercritical Fluid Chromatography (SFC) has known a strong regain of interest for the last 10 years, especially in the field of pharmaceutical analysis. Besides the development and validation of the SFC method in one individual laboratory, it is also important to demonstrate its applicability and transferability to various laboratories around the world. Therefore, an inter-laboratory study was conducted and published for the first time in SFC, to assess method reproducibility, and evaluate whether this chromatographic technique could become a reference method for quality control (QC) laboratories. This study involved 19 participating laboratories from 4 continents and 9 different countries. It included 5 academic groups, 3 demonstration laboratories at analytical instrument companies, 10 pharmaceutical companies and 1 food company. In the initial analysis of the study results, consistencies within- and between-laboratories were deeply examined. In the subsequent analysis, the method reproducibility was estimated taking into account variances in replicates, between-days and between-laboratories. The results obtained were compared with the literature values for liquid chromatography (LC) in the context of impurities determination. Repeatability and reproducibility variances were found to be similar or better than those described for LC methods, and highlighted the adequacy of the SFC method for QC analyses. The results demonstrated the excellent and robust quantitative performance of SFC. Consequently, this complementary technique is recognized on equal merit to other chromatographic techniques. Supercritical Fluid Chromatography (SFC) Inter-laboratory study Collaborative study Reproducibility Pharmaceutical impurities Salbutamol sulfate Marini, Roland verfasserin aut Desfontaine, Vincent verfasserin aut Veuthey, Jean-Luc verfasserin aut Kotoni, Dorina verfasserin (orcid)0000-0002-5847-2233 aut Losacco, Luca Gioacchino verfasserin aut Clarke, Adrian verfasserin aut Muscat Galea, Charlene verfasserin aut Mangelings, Debby verfasserin aut Jocher, Brandon M. verfasserin aut Regalado, Erik L. verfasserin (orcid)0000-0002-7352-6391 aut Plachká, Katerina verfasserin (orcid)0000-0001-9655-9199 aut Nováková, Lucie verfasserin aut Wuyts, Benjamin verfasserin aut François, Isabelle verfasserin aut Gray, Michael verfasserin aut Aubin, Andrew J. verfasserin aut Tarafder, Abhijit verfasserin aut Cazes, Maxime verfasserin aut Desvignes, Christophe verfasserin aut Villemet, Loic verfasserin aut Sarrut, Morgan verfasserin aut Raimbault, Adrien verfasserin aut Lemasson, Elise verfasserin aut Lesellier, Eric verfasserin aut West, Caroline verfasserin (orcid)0000-0001-7595-6777 aut Leek, Tomas verfasserin aut Wong, Mengling verfasserin aut Dai, Lulu verfasserin aut Zhang, Kelly verfasserin (orcid)0000-0001-6515-544X aut Grand-Guillaume Perrenoud, Alexandre verfasserin aut Brunelli, Claudio verfasserin aut Hennig, Philippe verfasserin aut Bertin, Sophie verfasserin aut Mauge, Fabien verfasserin aut Da Costa, Nathalie verfasserin aut Farrell, William P. verfasserin (orcid)0000-0002-3341-9831 aut Hill, Madeleine verfasserin aut Desphande, Niranjan verfasserin (orcid)0000-0002-8548-2242 aut Grangrade, Manish verfasserin aut Sadaphule, Santosh verfasserin aut Yadav, Ravi verfasserin aut Rane, Sandesh verfasserin aut Shringare, Shankar verfasserin aut Iguiniz, Marion verfasserin aut Heinisch, Sabine verfasserin aut Lefevre, Julien verfasserin aut Corbel, Estelle verfasserin aut Roques, Nicolas verfasserin aut Heyden, Yvan Vander verfasserin aut Guillarme, Davy verfasserin aut Hubert, Philippe verfasserin aut Enthalten in Journal of pharmaceutical and biomedical analysis New York, NY [u.a.] : Science Direct, 1983 161, Seite 414-424 Online-Ressource (DE-627)30271801X (DE-600)1491820-1 (DE-576)259483931 1873-264X nnns volume:161 pages:414-424 GBV_USEFLAG_U SYSFLAG_U GBV_ELV FID-PHARM SSG-OLC-PHA SSG-OPC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_150 GBV_ILN_151 GBV_ILN_224 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2034 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2064 GBV_ILN_2068 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2143 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2336 GBV_ILN_4037 GBV_ILN_4242 GBV_ILN_4251 GBV_ILN_4313 GBV_ILN_4326 GBV_ILN_4334 GBV_ILN_4338 44.40 Pharmazie Pharmazeutika AR 161 414-424 |
| allfieldsSound |
10.1016/j.jpba.2018.08.042 doi (DE-627)ELV000805505 (ELSEVIER)S0731-7085(18)31547-4 DE-627 ger DE-627 rda eng 610 DE-600 15,3 ssgn PHARM DE-84 fid 44.40 bkl Dispas, Amandine verfasserin aut First inter-laboratory study of a Supercritical Fluid Chromatography method for the determination of pharmaceutical impurities 2018 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Supercritical Fluid Chromatography (SFC) has known a strong regain of interest for the last 10 years, especially in the field of pharmaceutical analysis. Besides the development and validation of the SFC method in one individual laboratory, it is also important to demonstrate its applicability and transferability to various laboratories around the world. Therefore, an inter-laboratory study was conducted and published for the first time in SFC, to assess method reproducibility, and evaluate whether this chromatographic technique could become a reference method for quality control (QC) laboratories. This study involved 19 participating laboratories from 4 continents and 9 different countries. It included 5 academic groups, 3 demonstration laboratories at analytical instrument companies, 10 pharmaceutical companies and 1 food company. In the initial analysis of the study results, consistencies within- and between-laboratories were deeply examined. In the subsequent analysis, the method reproducibility was estimated taking into account variances in replicates, between-days and between-laboratories. The results obtained were compared with the literature values for liquid chromatography (LC) in the context of impurities determination. Repeatability and reproducibility variances were found to be similar or better than those described for LC methods, and highlighted the adequacy of the SFC method for QC analyses. The results demonstrated the excellent and robust quantitative performance of SFC. Consequently, this complementary technique is recognized on equal merit to other chromatographic techniques. Supercritical Fluid Chromatography (SFC) Inter-laboratory study Collaborative study Reproducibility Pharmaceutical impurities Salbutamol sulfate Marini, Roland verfasserin aut Desfontaine, Vincent verfasserin aut Veuthey, Jean-Luc verfasserin aut Kotoni, Dorina verfasserin (orcid)0000-0002-5847-2233 aut Losacco, Luca Gioacchino verfasserin aut Clarke, Adrian verfasserin aut Muscat Galea, Charlene verfasserin aut Mangelings, Debby verfasserin aut Jocher, Brandon M. verfasserin aut Regalado, Erik L. verfasserin (orcid)0000-0002-7352-6391 aut Plachká, Katerina verfasserin (orcid)0000-0001-9655-9199 aut Nováková, Lucie verfasserin aut Wuyts, Benjamin verfasserin aut François, Isabelle verfasserin aut Gray, Michael verfasserin aut Aubin, Andrew J. verfasserin aut Tarafder, Abhijit verfasserin aut Cazes, Maxime verfasserin aut Desvignes, Christophe verfasserin aut Villemet, Loic verfasserin aut Sarrut, Morgan verfasserin aut Raimbault, Adrien verfasserin aut Lemasson, Elise verfasserin aut Lesellier, Eric verfasserin aut West, Caroline verfasserin (orcid)0000-0001-7595-6777 aut Leek, Tomas verfasserin aut Wong, Mengling verfasserin aut Dai, Lulu verfasserin aut Zhang, Kelly verfasserin (orcid)0000-0001-6515-544X aut Grand-Guillaume Perrenoud, Alexandre verfasserin aut Brunelli, Claudio verfasserin aut Hennig, Philippe verfasserin aut Bertin, Sophie verfasserin aut Mauge, Fabien verfasserin aut Da Costa, Nathalie verfasserin aut Farrell, William P. verfasserin (orcid)0000-0002-3341-9831 aut Hill, Madeleine verfasserin aut Desphande, Niranjan verfasserin (orcid)0000-0002-8548-2242 aut Grangrade, Manish verfasserin aut Sadaphule, Santosh verfasserin aut Yadav, Ravi verfasserin aut Rane, Sandesh verfasserin aut Shringare, Shankar verfasserin aut Iguiniz, Marion verfasserin aut Heinisch, Sabine verfasserin aut Lefevre, Julien verfasserin aut Corbel, Estelle verfasserin aut Roques, Nicolas verfasserin aut Heyden, Yvan Vander verfasserin aut Guillarme, Davy verfasserin aut Hubert, Philippe verfasserin aut Enthalten in Journal of pharmaceutical and biomedical analysis New York, NY [u.a.] : Science Direct, 1983 161, Seite 414-424 Online-Ressource (DE-627)30271801X (DE-600)1491820-1 (DE-576)259483931 1873-264X nnns volume:161 pages:414-424 GBV_USEFLAG_U SYSFLAG_U GBV_ELV FID-PHARM SSG-OLC-PHA SSG-OPC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_150 GBV_ILN_151 GBV_ILN_224 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2034 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2064 GBV_ILN_2068 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2143 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2336 GBV_ILN_4037 GBV_ILN_4242 GBV_ILN_4251 GBV_ILN_4313 GBV_ILN_4326 GBV_ILN_4334 GBV_ILN_4338 44.40 Pharmazie Pharmazeutika AR 161 414-424 |
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Dispas, Amandine @@aut@@ Marini, Roland @@aut@@ Desfontaine, Vincent @@aut@@ Veuthey, Jean-Luc @@aut@@ Kotoni, Dorina @@aut@@ Losacco, Luca Gioacchino @@aut@@ Clarke, Adrian @@aut@@ Muscat Galea, Charlene @@aut@@ Mangelings, Debby @@aut@@ Jocher, Brandon M. @@aut@@ Regalado, Erik L. @@aut@@ Plachká, Katerina @@aut@@ Nováková, Lucie @@aut@@ Wuyts, Benjamin @@aut@@ François, Isabelle @@aut@@ Gray, Michael @@aut@@ Aubin, Andrew J. @@aut@@ Tarafder, Abhijit @@aut@@ Cazes, Maxime @@aut@@ Desvignes, Christophe @@aut@@ Villemet, Loic @@aut@@ Sarrut, Morgan @@aut@@ Raimbault, Adrien @@aut@@ Lemasson, Elise @@aut@@ Lesellier, Eric @@aut@@ West, Caroline @@aut@@ Leek, Tomas @@aut@@ Wong, Mengling @@aut@@ Dai, Lulu @@aut@@ Zhang, Kelly @@aut@@ Grand-Guillaume Perrenoud, Alexandre @@aut@@ Brunelli, Claudio @@aut@@ Hennig, Philippe @@aut@@ Bertin, Sophie @@aut@@ Mauge, Fabien @@aut@@ Da Costa, Nathalie @@aut@@ Farrell, William P. @@aut@@ Hill, Madeleine @@aut@@ Desphande, Niranjan @@aut@@ Grangrade, Manish @@aut@@ Sadaphule, Santosh @@aut@@ Yadav, Ravi @@aut@@ Rane, Sandesh @@aut@@ Shringare, Shankar @@aut@@ Iguiniz, Marion @@aut@@ Heinisch, Sabine @@aut@@ Lefevre, Julien @@aut@@ Corbel, Estelle @@aut@@ Roques, Nicolas @@aut@@ Heyden, Yvan Vander @@aut@@ Guillarme, Davy @@aut@@ Hubert, Philippe @@aut@@ |
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610 DE-600 15,3 ssgn PHARM DE-84 fid 44.40 bkl First inter-laboratory study of a Supercritical Fluid Chromatography method for the determination of pharmaceutical impurities Supercritical Fluid Chromatography (SFC) Inter-laboratory study Collaborative study Reproducibility Pharmaceutical impurities Salbutamol sulfate |
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Dispas, Amandine Marini, Roland Desfontaine, Vincent Veuthey, Jean-Luc Kotoni, Dorina Losacco, Luca Gioacchino Clarke, Adrian Muscat Galea, Charlene Mangelings, Debby Jocher, Brandon M. Regalado, Erik L. Plachká, Katerina Nováková, Lucie Wuyts, Benjamin François, Isabelle Gray, Michael Aubin, Andrew J. Tarafder, Abhijit Cazes, Maxime Desvignes, Christophe Villemet, Loic Sarrut, Morgan Raimbault, Adrien Lemasson, Elise Lesellier, Eric West, Caroline Leek, Tomas Wong, Mengling Dai, Lulu Zhang, Kelly Grand-Guillaume Perrenoud, Alexandre Brunelli, Claudio Hennig, Philippe Bertin, Sophie Mauge, Fabien Da Costa, Nathalie Farrell, William P. Hill, Madeleine Desphande, Niranjan Grangrade, Manish Sadaphule, Santosh Yadav, Ravi Rane, Sandesh Shringare, Shankar Iguiniz, Marion Heinisch, Sabine Lefevre, Julien Corbel, Estelle Roques, Nicolas Heyden, Yvan Vander Guillarme, Davy Hubert, Philippe |
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10.1016/j.jpba.2018.08.042 |
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first inter-laboratory study of a supercritical fluid chromatography method for the determination of pharmaceutical impurities |
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First inter-laboratory study of a Supercritical Fluid Chromatography method for the determination of pharmaceutical impurities |
| abstract |
Supercritical Fluid Chromatography (SFC) has known a strong regain of interest for the last 10 years, especially in the field of pharmaceutical analysis. Besides the development and validation of the SFC method in one individual laboratory, it is also important to demonstrate its applicability and transferability to various laboratories around the world. Therefore, an inter-laboratory study was conducted and published for the first time in SFC, to assess method reproducibility, and evaluate whether this chromatographic technique could become a reference method for quality control (QC) laboratories. This study involved 19 participating laboratories from 4 continents and 9 different countries. It included 5 academic groups, 3 demonstration laboratories at analytical instrument companies, 10 pharmaceutical companies and 1 food company. In the initial analysis of the study results, consistencies within- and between-laboratories were deeply examined. In the subsequent analysis, the method reproducibility was estimated taking into account variances in replicates, between-days and between-laboratories. The results obtained were compared with the literature values for liquid chromatography (LC) in the context of impurities determination. Repeatability and reproducibility variances were found to be similar or better than those described for LC methods, and highlighted the adequacy of the SFC method for QC analyses. The results demonstrated the excellent and robust quantitative performance of SFC. Consequently, this complementary technique is recognized on equal merit to other chromatographic techniques. |
| abstractGer |
Supercritical Fluid Chromatography (SFC) has known a strong regain of interest for the last 10 years, especially in the field of pharmaceutical analysis. Besides the development and validation of the SFC method in one individual laboratory, it is also important to demonstrate its applicability and transferability to various laboratories around the world. Therefore, an inter-laboratory study was conducted and published for the first time in SFC, to assess method reproducibility, and evaluate whether this chromatographic technique could become a reference method for quality control (QC) laboratories. This study involved 19 participating laboratories from 4 continents and 9 different countries. It included 5 academic groups, 3 demonstration laboratories at analytical instrument companies, 10 pharmaceutical companies and 1 food company. In the initial analysis of the study results, consistencies within- and between-laboratories were deeply examined. In the subsequent analysis, the method reproducibility was estimated taking into account variances in replicates, between-days and between-laboratories. The results obtained were compared with the literature values for liquid chromatography (LC) in the context of impurities determination. Repeatability and reproducibility variances were found to be similar or better than those described for LC methods, and highlighted the adequacy of the SFC method for QC analyses. The results demonstrated the excellent and robust quantitative performance of SFC. Consequently, this complementary technique is recognized on equal merit to other chromatographic techniques. |
| abstract_unstemmed |
Supercritical Fluid Chromatography (SFC) has known a strong regain of interest for the last 10 years, especially in the field of pharmaceutical analysis. Besides the development and validation of the SFC method in one individual laboratory, it is also important to demonstrate its applicability and transferability to various laboratories around the world. Therefore, an inter-laboratory study was conducted and published for the first time in SFC, to assess method reproducibility, and evaluate whether this chromatographic technique could become a reference method for quality control (QC) laboratories. This study involved 19 participating laboratories from 4 continents and 9 different countries. It included 5 academic groups, 3 demonstration laboratories at analytical instrument companies, 10 pharmaceutical companies and 1 food company. In the initial analysis of the study results, consistencies within- and between-laboratories were deeply examined. In the subsequent analysis, the method reproducibility was estimated taking into account variances in replicates, between-days and between-laboratories. The results obtained were compared with the literature values for liquid chromatography (LC) in the context of impurities determination. Repeatability and reproducibility variances were found to be similar or better than those described for LC methods, and highlighted the adequacy of the SFC method for QC analyses. The results demonstrated the excellent and robust quantitative performance of SFC. Consequently, this complementary technique is recognized on equal merit to other chromatographic techniques. |
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| title_short |
First inter-laboratory study of a Supercritical Fluid Chromatography method for the determination of pharmaceutical impurities |
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| author2 |
Marini, Roland Desfontaine, Vincent Veuthey, Jean-Luc Kotoni, Dorina Losacco, Luca Gioacchino Clarke, Adrian Muscat Galea, Charlene Mangelings, Debby Jocher, Brandon M. Regalado, Erik L. Plachká, Katerina Nováková, Lucie Wuyts, Benjamin François, Isabelle Gray, Michael Aubin, Andrew J. Tarafder, Abhijit Cazes, Maxime Desvignes, Christophe Villemet, Loic Sarrut, Morgan Raimbault, Adrien Lemasson, Elise Lesellier, Eric West, Caroline Leek, Tomas Wong, Mengling Dai, Lulu Zhang, Kelly Grand-Guillaume Perrenoud, Alexandre Brunelli, Claudio Hennig, Philippe Bertin, Sophie Mauge, Fabien Da Costa, Nathalie Farrell, William P. Hill, Madeleine Desphande, Niranjan Grangrade, Manish Sadaphule, Santosh Yadav, Ravi Rane, Sandesh Shringare, Shankar Iguiniz, Marion Heinisch, Sabine Lefevre, Julien Corbel, Estelle Roques, Nicolas Heyden, Yvan Vander Guillarme, Davy Hubert, Philippe |
| author2Str |
Marini, Roland Desfontaine, Vincent Veuthey, Jean-Luc Kotoni, Dorina Losacco, Luca Gioacchino Clarke, Adrian Muscat Galea, Charlene Mangelings, Debby Jocher, Brandon M. Regalado, Erik L. Plachká, Katerina Nováková, Lucie Wuyts, Benjamin François, Isabelle Gray, Michael Aubin, Andrew J. Tarafder, Abhijit Cazes, Maxime Desvignes, Christophe Villemet, Loic Sarrut, Morgan Raimbault, Adrien Lemasson, Elise Lesellier, Eric West, Caroline Leek, Tomas Wong, Mengling Dai, Lulu Zhang, Kelly Grand-Guillaume Perrenoud, Alexandre Brunelli, Claudio Hennig, Philippe Bertin, Sophie Mauge, Fabien Da Costa, Nathalie Farrell, William P. Hill, Madeleine Desphande, Niranjan Grangrade, Manish Sadaphule, Santosh Yadav, Ravi Rane, Sandesh Shringare, Shankar Iguiniz, Marion Heinisch, Sabine Lefevre, Julien Corbel, Estelle Roques, Nicolas Heyden, Yvan Vander Guillarme, Davy Hubert, Philippe |
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30271801X |
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c |
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| doi_str |
10.1016/j.jpba.2018.08.042 |
| up_date |
2024-07-06T19:14:27.375Z |
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|
| score |
7.39966 |