Approaches to Assess, Analyze, and Control Genotoxic Impurities in Drug Substance Development

2014 ◽  
pp. 362-383
Keyword(s):  
Drug Substance ◽  
Genotoxic Impurities ◽  
And Control

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.

Detection of Two Genotoxic Impurities in Drug Substance and Preparation of Imatinib Mesylate by LC–MS/MS

2020 ◽  
Vol 83 (7) ◽  
pp. 821-828
Author(s):  
Dong Wang ◽  
Lijun Luo ◽  
Yue Peng ◽  
Jing Wang ◽  
Jing Liang ◽  
...  
Keyword(s):  
Imatinib Mesylate ◽  
Drug Substance ◽  
Genotoxic Impurities

scholarly journals Stress Factors in mAb Drug Substance Production Processes: Critical Assessment of Impact on Product Quality and Control Strategy

2020 ◽  
Vol 109 (1) ◽  
pp. 116-133 ◽  
Author(s):  
Tapan K. Das ◽  
Linda O. Narhi ◽  
Alavattam Sreedhara ◽  
Tim Menzen ◽  
Christoph Grapentin ◽  
...  
Keyword(s):  
Product Quality ◽  
Control Strategy ◽  
Critical Assessment ◽  
Drug Substance ◽  
Stress Factors ◽  
Production Processes ◽  
And Control

Superficial analysis of sources and control of genotoxic impurities in pharmaceutical manufacturing

2017 ◽  
Vol 17 (3) ◽  
pp. 235-237
Author(s):  
XiaoDan LIU ◽  
◽  
Feng LU ◽  
Wu HE ◽  
◽  
...  
Keyword(s):  
Pharmaceutical Manufacturing ◽  
Genotoxic Impurities ◽  
And Control
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