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

Determination of residual phenylhydrazines in drug substances by high-performance liquid chromatography with pre-column derivatization

2019 ◽  
Vol 11 (48) ◽  
pp. 6146-6152
Author(s):  
Jiaxin Li ◽  
Eyoro Noah Nadine Joelle ◽  
Qian Yang ◽  
Feng Zheng ◽  
Wenyuan Liu ◽  
...  
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Hplc Method ◽  
Drug Substances ◽  
Genotoxic Impurities

A selective, sensitive and general HPLC method with pre-column derivatization was developed for the determination of residual phenylhydrazines (known as genotoxic impurities) in drug substances.

Acceptability of Low Levels of Genotoxic Impurities in New Drug Substances

2004 ◽  
Vol 18 (4) ◽  
pp. 221-223 ◽  
Author(s):  
Peter Kasper ◽  
David Kirkland ◽  
Bernard Leblanc ◽  
Per Sj??berg ◽  
Per Spindler
Keyword(s):  
New Drug ◽  
Drug Substances ◽  
Genotoxic Impurities ◽  
Low Levels

Acceptability of Low Levels of Genotoxic Impurities in New Drug Substances

2004 ◽  
Vol 18 (4) ◽  
pp. 215-220 ◽  
Author(s):  
Bernard Leblanc ◽  
Claude Charuel ◽  
Warren Ku ◽  
Ron Ogilvie
Keyword(s):  
New Drug ◽  
Drug Substances ◽  
Genotoxic Impurities ◽  
Low Levels
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