Impurities refer to unwanted substances or contaminants present in API or drug product. It can arise during manufacturing, handling, or storage of API or drug product.
The two major types of pharmaceutical impurities:
- Inorganic impurities: Metals, salts, etc.
- Organic impurities: Residual solvents, by-products etc.
Following two guidelines should follow to control the impurities in pharmaceutical industries:
- ICH Q3A (R2) – Impurities in New Drug Substances
- ICH Q3B (R2) – Impurities in New Drug Products
You can set the impurities limit through using – Impurities Calculator.
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