Der Pharma Chemica
Journal for Medicinal Chemistry, Pharmaceutical Chemistry, Pharmaceutical Sciences and Computational Chemistry
ISSN: 0975-413X
Vinod Bairagi
Department of Pharmacology, Bharati Vidyapeeth College of Pharmacy, Navi Mumbai, IndiaPublications
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Review Article
Current Trends for Regulatory Requirements of Elemental Impurity in Drug Substance for Regulatory Market
Author(s): Chetna Malwal*, Rashid Azeez and Vinod Bairagi
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... Read More»
DOI: 10.4172/0975-413X.16.1.192-196