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Tag: nitrosamine impurity

Impurity Isolation vs Chemical Synthesis: Which Strategy Truly Wins

Impurity Isolation vs Chemical Synthesis: Which Strategy Truly Wins?

Pharmaceutical impurities are unavoidable in the drug manufacturing process. They are also known as API impurities.
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Regulatory Requirements for Impurity Reference Standards

Regulatory Requirements for Impurity Reference Standards

API impurity reference standards are essential tools in pharmaceutical analysis. They ensure accurate identification, quantification, and control of impurities in
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FDA Nitrosamine Categorization: Small-Molecule Nitrosamine and NDSRIs

The issue of nitrosamine impurities has become one of the most significant regulatory concerns in the pharmaceutical industry since 2018.
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The Nitrosamine puzzle: What We Learned in the Last Five Years

The Nitrosamine puzzle: What We Learned in the Last Five Years

The Nitrosamine (NA) issue, often termed the "Saga," has been a focal point of attention for both the pharmaceutical sector
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Controlling Nitrosamine Impurities

The nitrosamines may occur in very small quantities in some drugs but they are a potential carcinogen...
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