How nitrosamine contamination is transforming pharmaceutical quality control standards
By
Kiran Kumar Kurella, special to C&EN
Summary
The article discusses how nitrosamine contamination discovered in 2018 in angiotensin receptor blocker medicines has fundamentally transformed pharmaceutical quality control. What began as a crisis with global recalls and regulatory investigations has evolved into a defining benchmark for the pharmaceutical sector. The contaminants, once viewed as anomalies, are now catalyzing a sea change in how the industry approaches quality assurance and impurity testing.
Source
bskyHow nitrosamine contamination is transforming pharmaceutical quality control standardscen.acs.orgKey quotes
· 3 pulledA pharmaceutical quality crisis involving nitrosamine contamination began in 2018 with the discovery of N-nitrosodimethylamine, a type of nitrosamine, in angiotensin receptor blocker medicines, triggering global recalls, regulatory investigations
Once viewed as anomalies, the contaminants have become a defining benchmark for the pharmaceutical sector
Nitrosamines are catalyzing a sea change in pharma quality control
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