Item no.
USP-CM-GMP-01
Unit
Each
Shipment details
No Dangerous Good
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Description
Learn about essential components for designing global stability programs for pharmaceutical products: regulations, operations, testing and investigations. Topics include cGMP, USP, FDA, ICH and WHO stability requirements for establishing expiration dating and label storage criteria, technical and regulatory aspects that may affect design cost-effectiveness and compliance, and stabilityindicating methods for monitoring product quality throughout its shelf life. Matrix and bracketing options to reduce testing, stability data evaluation and investigation of out-of-trend and out-ofspecifications are also addressed. This course will also cover USP <1225> Validation, USP <1226> Verification.
Miscellaneous
Certificate of Analysis (specimen)
Reference Material CoA specimen: for the current lot, please contact your customer service representative at info@labmix24.com
Product data sheet
View all available product details e.g. description, analytes/parameters, CAS Number, concentrations/values, sales unit/product format, method, source, transport information
US Pharmacopeia Standards set a global benchmark, enabling efficient, reliable, and cost-effective development and quality control of pharmaceuticals.
Official USP Reference Standards are highly characterized physical specimens intended for quality control use when conducting assays and tests for medicines as described in the USP-NF. When you conduct tests and assays required by the USP-NF using the USP reference standards specified, the results can be considered conclusive.
As a USP-Authorized Distributor, we offer the following products and services:
- USP Reference Standards
- USP Pharmaceutical Analytical Impurities
- USP Training and educational programs