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Various regulatory authorities such as the International Conference on Harmonization (ICH), the United States Food and Drug Administration (FDA), and the Canadian Drug and Health Agency (CDHA) are emphasizing the purity requirements and the identification of impurities in Active Pharmaceutical Ingredients (APIs).
The various sources of impurity in pharmaceutical products are reagents, heavy metals, ligands, catalysts, other materials like filter aids, and the like, degraded end products obtained during/ after manufacturing of bulk drugs from hydrolysis, photolytic cleavage, oxidative degradation, enantiomeric impurity, and so on.
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Impurities in Pharmaceutical Substances Notes Includes Topics
The most important topics regarding the Impurities in Pharmaceutical Substances Notes are listed below which will provide you with a general concept about the topics.
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- Introduction
- Sources of Impurities
- Raw Materials
- Method of Manufacture
- Manufacturing Hazards
- Instability of the Products
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