Compendial Testing & Regulatory Guidance
Drug sponsors and applicants are required to propose specifications (i.e., attributes, analytical procedures, and acceptance criteria) for the excipients, drug substances and drug products in their applications.
These specifications should adhere to the quality standards in the United States Pharmacopoeia/National Formulary (USP/NF), the British Pharmacopoeia (BP), the European Pharmacopoeia (EP), or the Japanese Pharmacopoeia (JP).
Compendial pharmacopoeia tests are standardized protocols for many pharmaceutical raw materials and finished products. Testing and compliance to these standards detailed within compendial methods is a basic requirement for global manufacturing, release and distribution of pharmaceutical ingredients and drug products.
Speak to an expert today and get further support on compendial testing and complying to regulatory requirements.
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Related Resources
- Flyer: A Quick Guide to Successful Dissolution Testing
From development to drug release, this interactive PDF outlines a range of reliable, consistent filters and reagents for dissolution testing protocol.
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Related Webinars
This presentation gives a high level overview of the specific values of pharmacopeial standards.
Learn strategies to improve productivity and reduce costs in your pharmaceutical analyses with U/HPLC method adaptation.
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