rac N-Nitroso Thiazolidine-4-carboxylic Acid

Potential Irbesartan Nitrosamine N‑Nitroso Thiazolidine-4-carboxylic Acid Molecular formula C₄H₆N₂O₃S, molecular weight 162.17 g/mol, CAS number 86594‑16‑3 / 88381‑44‑6 is a nitrosamine impurity that could theoretically form from Irbesartan under conditions favoring nitrosation, such as exposure to nitrite, acidic or oxidative environments, or during API synthesis and degradation. While this impurity is commercially available as a reference standard for analytical testing, it is not currently listed by the USFDA as a Nitrosamine Drug-Substance Related Impurity (NDSRI), and no official acceptable intake, potency category, or USP standard has been published.

Manasa Life Sciences manufactures nitrosamine impurities in Hyderabad, India, and supplies products to markets across Asia, Europe, Africa, the GCC, and the UAE, ensuring reliable delivery, full traceability, and Good Documentation Practices (GDP) for nitrosamine impurities. And also we support complete nitrosamine-control readiness by supplying certified nitrosamine impurity reference standards, conducting in-depth risk assessments, and developing and validating ultra-sensitive LC-MS/MS and GC-MS analytical methods. Our solutions enable accurate detection, quantification, and control of nitrosamine impurities whether theoretical, synthesis-related, or degradation-derived helping manufacturers meet USP-relevant expectations, maintain strict global regulatory compliance, and safeguard patient safety.