Item no.
USP-CM-476-01
Unit
Each
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Description
This course integrates ICH Guidance and FDA policy for impurities, relevant USP General Chapters about impurities, and USP's approach to impurities in monographs. It also provides insights to USP-NF General Chapters <476> and <1086> and include case studies for impurities in the development and revision of USP monographs. /// Upon completion of this course, you will be able to: Discuss the origin and classification of impurities in pharmaceuticals. / Explain global guidance's for impurities. / Describe the USP approach to impurities in drug substances and drug products. / Discuss the USP general chapters on impurities. /Explain the USP approach to harmonization across pharmacopeia. / Demonstrate knowledge of USP's approach for impurities in documentary standards via case studies. /// Duration: 3/29/2022, 3:00 AM EDT - 3/31/2022, 5:30 AM EDT
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