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Tag: nitrosamine

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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Mutagenic-Impurities-Risk-Assessment-Under-ICH-M7

Mutagenic Impurities Risk Assessment Under ICH M7

In pharmaceutical manufacturing the mutagenic impurities are among the most critical safety concerns. These impurities are responsible for the damage
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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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