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.
Related Technical Articles
- An overview of nitrosamine impurity testing, worldwide regulations, and key considerations in filter selection for sample preparation and analysis.
- USP methods continuously revised for modernization and improved results in drug testing.
- Determination of the progestin medication, Drospirenone, using Purospher® STAR RP-18e Hibar® HPLC column and meeting the system suitability criteria as described in the USP monograph.
- The titer determination or standardization of a titration solution is essential for accurate and reliable titration results.
- Control elemental impurities in drug products with analytical methods and materials to ensure patient safety.
- This application note describes the LC-MS-based quantitative analysis of known nitrosamine impurities following procedures 1 and 3 as given in USP general chapter <1469>.
- See All (15)
Related Protocols
- Lopinavir assay setup saves time and improves efficiency with shorter columns, meeting European pharmacopoeia guidelines.
- Aripiprazole, an atypical antipsychotic, treats schizophrenia, bipolar disorder, and major depressive disorder.
- Chloroquine Phosphate HPLC Assay meets system suitability criteria with good resolution, reproducibility, and sensitivity.
- Folic acid vs. folate differences and biological activities; implications in fortified foods and supplements for human health.
- Sildenafil, sold under the brand name Viagra, among others, is a medication used to treat erectile dysfunction and pulmonary arterial hypertension.
- GB method with Ascentis® Express C30 column achieves baseline resolution for Vitamin A and E critical pair.
Find More Articles and Protocols
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.
- Poster: HPLC Packings for USP Compendial Methods
HPLC USP columns wallchart
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.
To continue reading please sign in or create an account.
Don't Have An Account?