The purpose of this study is to widely disseminate these new procedures to users, solicit batch data using these procedures, and gain feedback, allowing USP to set meaningful acceptance criteria based on industry batch data.
This study is sponsored by the USP Unfractionated Heparin Expert Panel, which will review comments and batch data generated from the study. All comments and batch data will be treated confidentially and batch data will be blinded to safeguard the identity of participants. Based on the comments and batch data received the USP Unfractionated Heparin Expert Panel may further revise the Protein Impurities and Nucleotidic Impurities procedures prior to publication for comment in Pharmacopeial Forum. It is USP's intent to include these new procedures as part of the Stage 3 revision of the USP Heparin Sodium monograph.
• RSVP to call for Study Participation: Monday August 15, 2011
• Deadline for USP sample dispatch: August 31, 2011
• Deadline for Participants to submit full data package: February 1, 2012
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