Introduction Nitrosamine Impurity Limits for Health Canada Submissions Nitrosamines are chemical compounds typically formed under specific conditions involving nitrites and […]
Introduction In the evolving landscape of pharmaceutical regulations, Nitrosamine Impurity Analysis for FDA Approval has become a non-negotiable requirement. Ever
FDA Approval and Nitrosamine Impurity Analysis: How to Ensure Your Product Passes Read More »
Pharmaceutical manufacturers, API producers, and drug product developers must stay vigilant to ensure their products are free from harmful contaminants.
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Introduction: The Rising Need for Nitrosamine Impurity Testing for Drug Products Nitrosamines have emerged as a major safety concern in
Eliminating Risk: Comprehensive Nitrosamine Impurity Testing for Drug Products Read More »
Introduction The emergence of nitrosamines as genotoxic impurities has triggered global regulatory scrutiny, necessitating a proactive approach to nitrosamine risk
Nitrosamine Risk Assessment for NDAs: Regulatory Requirements and Testing Solutions Read More »
Introduction As Health Canada tightens its regulatory oversight on pharmaceutical impurities, nitrosamine impurity testing for Health Canada has become a
Introduction When pharmaceutical and biotechnology companies seek Extractables and Leachables (E&L) testing services , one aspect is to have idea
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Introduction: Extractables and Leachables (E&L) Testing for Inhalation and Nasal Drug Products has become a regulatory imperative in 2025. Given
Introduction E&L studies for pharmaceutical packaging are essential for ensuring the safety, quality, and regulatory compliance of drug products. These
E&L Studies for Pharmaceutical Packaging: A Step-by-Step Guide Read More »
In pharmaceutical and biopharmaceutical development, regulatory expectations for safety have become more stringent. One area where this is especially evident
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