ICH Q3C RESIDUAL SOLVENTS, API, R&D, Class-1, Class-2 and Class-3 solvents
Автор: “PharmaInsightsHub”
Загружено: 2024-02-01
Просмотров: 62
Описание:
ICH Q3C is a specific guideline within the ICH framework, focusing on the control of impurities, specifically residual solvents, in pharmaceutical products.
Residual solvents are organic volatile compounds used in the manufacturing process but present in the final product.
The guideline establishes permissible limits for these solvents, reflecting a balance between ensuring safety and allowing for practical manufacturing processes.
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