What have we learned from the nitrosamine crisis? Kumar Jeetendra | May 8, 2021 The pharmaceutical industry is facing an ongoing issue with genotoxic impurities (GTIs). Over the past year, we have witnessed genotoxic impurities affect several drugs, including those used to treat elevated blood pressure, heartburn and acid reflux. Angiotensin II receptor blockers (including valsartan, losartan and irbesartan), along with ranitidine and nizatidine, were recalled to investigate several …
Detecting Nitrosamine Impurities: Advances in Analytical Techniques Kumar Jeetendra | October 30, 2023 Potentially dangerous substances known as nitrosamines can appear as contaminants in a range of consumer goods. To guarantee the safety of the product, nitrosamine impurities must be found and measured. This article examines the most current developments in nitrosamine detection analytical techniques, which improve our capacity to track and control their occurrence in consumer products. …
How to choose the right disinfectant for laboratory equipment? Kumar Jeetendra | September 1, 2025 A broken link in contamination control can bring down an entire pharmaceutical empire. In early 2025, four major Indian pharmaceutical companies — Glenmark, Sun Pharma, Dr. Reddy’s, and Zydus — faced multiple drug recalls due to impurities and compliance breaches. Glenmark recalled over 1.4 million bottles of atomoxetine for nitrosamine impurities, a carcinogenic contaminant. Sun …
PHARMA STABILITY & IMPURITY TESTING :Securing Quality from Lab to Market Kumar Jeetendra | September 1, 2025 Within the pharmaceutical arena, the promise of medicine always rests on scientific assurances of safety, efficacy, and uniformity. Every dosage form—pills, injectables, or capsules—emerges from an equally demanding program of stability and impurity testing, two safeguards that oversee quality as metabolically as any dose itself. The Justification for Stability Studies Stability testing quantifies the shelf-life …
