scholarly journals Genotoxic Impurities in Pharmaceuticals

10.5772/24030 ◽  
2012 ◽  
Author(s):  
Abolghasem Jouyban ◽  
Hamed Pars
Keyword(s):  
Genotoxic Impurities

Recent advances in trace analysis of pharmaceutical genotoxic impurities

2010 ◽  
Vol 51 (5) ◽  
pp. 999-1014 ◽  
Author(s):  
David Q. Liu ◽  
Mingjiang Sun ◽  
Alireza S. Kord
Keyword(s):  
Trace Analysis ◽  
Recent Advances ◽  
Genotoxic Impurities

scholarly journals Low Level Quantification of Potential Genotoxic Impurities In Telmisartan Drug Substance by HPLC

2021 ◽  
Vol 11 (3) ◽  
pp. 24-35
Author(s):  
K. Srivalli ◽  
N. Annapurna ◽  
K. Raghu Babu ◽  
C. Ramdas ◽  
Hemant Kumar Sharma ◽  
...  
Keyword(s):  
Drug Substance ◽  
Low Level ◽  
Genotoxic Impurities

scholarly journals A SELECTIVE AND SENSITIVE LC-MS/MS METHOD FOR QUANTIFICATION OF FOUR POTENTIAL GENOTOXIC IMPURITIES IN ATAZANAVIR SULFATE DRUG SUBSTANCE IN TRACE LEVEL

2021 ◽  
pp. 137-144
Author(s):  
SIVA JYOTHI N. ◽  
VENKATNARAYANA MUVVALA
Keyword(s):  
Mobile Phase ◽  
Multiple Reaction Monitoring ◽  
Research Work ◽  
Active Pharmaceutical Ingredient ◽  
Drug Substance ◽  
Genotoxic Impurities ◽  
Liquid Chromatography Tandem Mass ◽  
Short Run ◽  
Acquity Uplc ◽  
Atazanavir Sulfate

Objective: The main objective of current research work is to develop and validate a rapid, sensitive and selective liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for the trace analysis of four potential genotoxic impurities in Atazanavir Sulfate drug substance. Methods: LC-MS/MS analysis of four potential genotoxic impurities was done on Acquity UPLC CSH C18 (100 mm × 2.1 mm, 1.7 μm) column. In this method, mobile phase A (10 mM ammonium acetate) mobile phase B (methanol: acetonitrile (90:10, v/v) with gradient run with the flow rate of 0.2 ml/min. The method was developed with the short run time of 13 min. Triple quadrupole mass detector coupled with positive electrospray ionization was used for the quantification of genotoxic impurities in multiple reaction monitoring (MRM) mode. Results: The method was linear in the range of 0.3 ppm to 4.5 ppm for BOC Hydrazine Acid impurity, BOC Epoxide and Keto impurity with a correlation coefficient not less than 0.9994. The accuracy of the method was in the range of 99.26% to 105.71% for all four potential genotoxic impurities (PGIs). No impurities were identified in the Atazanavir Sulfate active pharmaceutical ingredient sample. Conclusion: The proposed method is specific, linear, precise, accurate, robust and stable for the quantification of the four genotoxic impurities at very low levels.

Regulatory Expectations Towards Genotoxic Impurities in Drug Substances: DMF and ASMF Perspective

2014 ◽  
Vol 18 (7) ◽  
pp. 834-835 ◽  
Author(s):  
Nanduri V. V. S. S. Raman ◽  
Adapa V. S. S. Prasad
Keyword(s):  
Drug Substances ◽  
Genotoxic Impurities

Genotoxic Impurities: A Risk in Perspective

2011 ◽  
pp. 193-218
Author(s):  
Dave Elder ◽  
Jim Harvey
Keyword(s):  
Genotoxic Impurities

Determination of genotoxic impurities in pharmaceutical substances

2020 ◽  
Vol 69 (7) ◽  
pp. 10-16
Author(s):  
Olga Vyacheslavovna Ananyina ◽  
Mikhail Dmitrievich Khorolsky ◽  
Galina Vladislavovna Ramenskaya ◽  
Evgeniy Andreevich Zhukov ◽  
Natalia Viktorovna Maslennikova
Keyword(s):  
Pharmaceutical Substances ◽  
Genotoxic Impurities
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