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THE PHARMA REVIEW (NOV DEC 2018)

Angiotensin II Receptor Blocker - Determination of both NDMA and NDEA Simultaneously in Sartan Drug Substance and Drug Products - Genotoxic Impurity - Regulatory Agency's Method

Sundar Ganesan

Introduction:

Description: As standards and regulations go on upgrading, but very basic GMP/GLP Requirements with respect to Impurities are not properly handled in industry due to various reasons, but regulators are expecting the following Safety and Efficacy measures are mandatory.
USFDA and EDQM published the methods to determine the both NDMA and NDEA simultaneously in sartan drug substance and drug products.

 

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