Type of Posting: General Announcement
Posting Date: 26–Apr–2013
USP is seeking public participation in a new survey about organic impurities testing in drug substances and drug products. This survey is designed to assist USP in determining proper approaches in the development, revision, and modernization of USP–NF documentary standards, including monographs and general chapters, and associated reference materials regarding organic impurities (as opposed to inorganic or elemental impurities).
An impurity is any component of a drug substance that is not the chemical entity defined as the drug substance and in addition, for a drug product, any component that is not a formulation ingredient. The presence of such unwanted material, even in small amounts, could affect the efficacy and safety of pharmaceutical products.
The participation of stakeholders in this research will be invaluable. In appreciation for this participation, survey respondents will have the option of entering into a drawing to win one of five $100 Amazon.com gift certificates.
Stakeholders wishing to participate in this study should register here. A survey invitation will be distributed to registrants shortly.
Should you have any questions, please contact Julia Berik, Senior Market Research Associate (firstname.lastname@example.org or 301-230-7439).