Analytical Testing and Control for Genotoxic Impurities in Drug Substances

2014 ◽  
pp. 338-361
Keyword(s):  
Drug Substances ◽  
Genotoxic Impurities ◽  
And Control

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

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

Occupational Safety and Health and Illicit Opioids: State of the Research on Protecting Against the Threat of Occupational Exposure

2021 ◽  
Vol 31 (3) ◽  
pp. 315-329 ◽  
Author(s):  
Casey Basham ◽  
Audrey Cerles ◽  
Margaret Rush ◽  
Marissa Alexander-Scott ◽  
Lee Greenawald ◽  
...  
Keyword(s):  
Occupational Exposure ◽  
Personal Protective Equipment ◽  
Occupational Safety ◽  
Occupational Safety And Health ◽  
Protective Equipment ◽  
Engineering Controls ◽  
Drug Substances ◽  
Safety And Health ◽  
And Control ◽  
Job Activities

The nationwide opioid crisis continues to affect not only people who use opioids but also communities at large by increasing the risk of accidental occupational exposure to illicit opioids. In addition, the emergence of highly potent synthetic opioids such as fentanyl and carfentanil increases the need to protect workers who may encounter unknown drug substances during job activities. To support the National Institute for Occupational Safety and Health Opioids Research Gaps Working Group, we examined the state of the literature concerning methods to protect workers against accidental occupational exposure to illicit opioids, and have identified unmet research needs concerning personal protective equipment, decontamination methods, and engineering controls. Additional studies are needed to overcome gaps in technical knowledge about personal protective equipment, decontamination, and control methods, and gaps in understanding how these measures are utilized by workers. Increasing our knowledge of how to protect against exposure to illicit opioids has the potential to improve occupational health across communities.

Risk assessment and control of potentially genotoxic impurities: Implementation of a fully integrated approach

2016 ◽  
Vol 258 ◽  
pp. S203-S204
Author(s):  
C. Devastato ◽  
E. Fioravanzo ◽  
S. Kovarich ◽  
M. Pavan ◽  
C. Schwab ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Integrated Approach ◽  
Fully Integrated ◽  
Genotoxic Impurities ◽  
And Control

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.

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