Nitrosamine Impurities Analyses Application Guide

Overview

Confidently Detect Trace Nitrosamine Impurities in Pharmaceuticals.

Recent recalls for unacceptable levels of nitrosamine impurities has spurred regulatory authorities to publish analytical testing methods for increasingly stringent regulations regarding the detection and quantification of nitrosamine impurities in drug substances and products. The Nitrosamine Impurities Application Guide provides analytical details for a broad range of drugs with technologies, proven methods and resources to simplify your nitrosamine impurities analysis.

Key Objectivesï¼š

Understand what mutagenic impurities are and why itâ€™s important to characterize and quantify them, even when present in trace amounts.
Understand the current regulatory guidelines for nitrosamines analysis in drug substance and product in Angiotensin II Receptor Blockers (sartan), ranitidine and metformin drugs
Learn detailed methods for the confident identification and quantification of nitrosamines in APIs and drugs

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