Current Trends for Regulatory Requirements of Elemental Impurity in Drug Substance for Regulatory Market
Journal Title: Der Pharma Chemica - Year 2023, Vol 16, Issue 1
Abstract
The presence of elemental impurities in drug substances has gained increasing attention in the pharmaceutical industry due to their potential impact on product safety and efficacy. Regulatory agencies worldwide have established guidelines and requirements to ensure the control and mitigation of elemental impurities in drug substances and products. This review article provides a comprehensive analysis of the regulatory landscape surrounding elemental impurity control, focusing on both drug substances and the broader pharmaceutical market.
Authors and Affiliations
Chetna Malwal1*, Rashid Azeez1 and Vinod Bairagi
Keywords
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- EP ID EP742478
- DOI 10.4172/0975-413X.16.1.192-196
- Views 34
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