Impurities for Development | CPhI North America

CPhI North America is part of the Informa Markets Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

 

View, browse and sort the ever-growing list of sessions by pass type, track, and format. With this Session Scheduler, you can build your schedule in advance and access it during the show via export or with the Mobile App, once live. Sessions do fill up and seating is first come, first serve, so arrive early to sessions that you would like to attend.

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