WitrynaImpurities can be classified into the following categories: • Organic impurities (process- and drug-related) • Inorganic impurities • Residual solvents Organic impurities can arise during the manufacturing process and/or storage of the new drug substance. They can be identified or unidentified, volatile or non-volatile, and include: WitrynaEMA/CVMP/814/00 Rev. 2 . EMA/HMPC/201116/2005 Rev. 2 . Committee for Medicinal Products for Human Use (CHMP) ... requirements for impurities. Given the nature of this update, a concept paper or public consultation was not required. Guideline on quality of herbal medicinal products/traditional herbal medicinal products
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How to quickly identify impurities in plastic materials
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