Course Description:
This course refers to USP General Chapters on impurities, including an overview of the analytical methods for impurities found in the USP–NF, and a review of USP General Chapter <1086>, Impurities in Drug Substances and Drug Products.
During the hands-on session, participants will perform testing with HPLC for organic impurities and related substances in dosage forms or drug substances. Participants will also manually calculate the results after performing manual integration of the HPLC measurements.
Pricing varies. Please inquire for more info at https://go.usp.org/Services.
Upon completion of this course, you will be able to
- Differentiate between impurities in drug substances and drug products.
- Perform testing for related substances and impurities in drug substances and drug products.
Who should participate:
- National and private Pharmaceutical QC laboratories
- QA Manager
- QC Chemist
- QC Manager
- R&D