Impurities for Development | CPhI North America

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Impurities for Development

Ashok Dang, Ph.D. (Senior Director of Strategic Marketing and Program Operations for Chemical Medicines, US Pharmacopeia (USP))

Date: Wednesday, May 1

Time: 2:30pm - 2:55pm

Track: Exhibitor Showcase

Vault Recording: TBD

Impurities can occur naturally within source materials, be added intentionally as part of a product’s synthesis, be introduced inadvertently during processing and manufacturing, or form during the shelf life of the product. Manufacturers have to ensure the quality and consistency of ingredients that go into a final pharmaceutical product. As a result, manufacturers have to deal with many impurities-related demands during the development cycle, including:
· Prediction of likely impurities
· Detection, identification, quantitation and characterization of impurities
· Control of impurities levels or degradation products
· Compliance with regulatory expectations

You will learn about:
a. Impurities (an overview)
b. USP approaches for impurities
c. FDA approaches for impurities
d. The USP Impurities for Development program