Key Issue: Heparin
Original Posting: 21–Aug–2009; Last Update: 05–Nov–2012
Contacts
- Scientific Liaison: Anita Szajek (aey@usp.org or +1-301-816-8325)
- Reference Standards Technical Support: RS Technical Service (rstech@usp.org or +1-301-816-8129)
- Reference Standards Ordering: USP Customer Service (custsvc@usp.org or +1-800-227-8772)
- Media: Laura Provan (lnp@usp.org or +1-301-816-8268)
Update s
- Heparin Sodium Monograph Comment Period Extended (30–Nov–2012)
- Heparin Labeling Revisions (05–Nov–2012)
The labeling sections of the currently official Heparin Sodium Injection and Heparin Lock Flush Solution monographs in USP–NF are being revised to ensure that labels comply with General Chapter <1> Injections. General Chapter <1> requires that the label reflect strength per total volume as the primary expression of strength, followed in close proximity by strength per milliliter (mL). An example of an expression of product strength as articulated in General Chapter <1> would be “30,000 USP Units/30 mL (1000 USP Units/mL).”
- [Press Release] USP Announces Change in Labeling Requirement for Total Strength of Heparin to Help Minimize Medication Errors (05–Nov–2012)
- USP Heparin Sodium Injection IRA–PF38(3)
- USP Heparin Lock Flush Solution IRA–PF38(5)
- Notice of Intent to Revise Announcement: The Labeling Section of the USP Sodium Injection Monograph
- Notice of Intent to Revise Announcement: The Labeling Section of the USP Heparin Lock Flush Solution Monograph
- Heparin Stage 3 Revisions (22–May–2012)
The third and latest round of revisions to USP’s heparin standards will bring even greater sensitivity and precision to the tests and reference materials used to help ensure heparin quality. In response to requests from the FDA, USP has identified and incorporated into the standards new and improved procedures and tighter specifications for detecting and deterring the presence of oversulfated chondroitin sulfate (OSCS) as well as improved control for protein and nucleic acid impurities. FDA also requested the addition of a heparin molecular weight determination procedure, which is included in the proposed revisions along with a related reference material, USP Heparin Sodium Molecular Weight Calibrant RS.
Past Updates
Revision Announcements
- Heparin Workshop; Intent to Revise—Protamine Monographs (12–Mar–2010)
- Stage 2 Commentary (01–Jan–2010)
- Compendial Notice: Stage 2 Posting (22–Dec–2009)
- Official Stage 2 Monographs (01–Oct–2009)
- USP Statement on Potency Unit Assignment and Harmonization (21–Aug–2009)
- Notice of Heparin Stage 2 Interim Revision Announcements (24–June–2009)
Additional Resources
- Learn more about the August 14 workshop (14–Aug–2012)
- [Video] USP Experts on Heparin (14–Aug–2012)
- 5th Workshop on the Characterization of Heparin Products (14–Aug–2012)
- [Press Release] Protection of Global Heparin Supply Focus of International Meeting (02–Aug–2012)—August Workshop on Characterization of Heparin Products Co-Hosted by USP and Partner Organizations
- [Press Release] Quality Standards for Heparin Further Strengthened (22–May–2012)
- Heparin Study Participation (02–Aug–2011)
Call for USP Heparin Study Participation-Protein Impurities and Nucleotidic Impurities
USP is inviting stakeholders, especially heparin API manufacturers, to participate in evaluating and setting acceptance criteria for newly developed Protein Impurities and Nucleotidic Impurities procedures in the USP Heparin Sodium monograph. 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.
To be considered for the study, candidates interested in participating must complete the eligibility questions available for download below. Once completed, the form should be sent to Dr. Anita Szajek via email (aey@usp.org) by Monday August 15, 2011. If you meet the requirements and are selected to participate in the study, you will receive study protocols and a sample by August 31. USP appreciates your continuing support in setting public standards.
Deadlines:
- 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
- Supply of Blood Thinner Heparin Further Secured (01–Oct–2009)
- Heparin Workshop Presentations (24–Aug–2009)
- Patient Safety Advanced by Revised Heparin Standards (30–July–2009)
- Proceedings—3rd Workshop on the Characterization of Heparin Products (27–Jul–2009)
- Presentation slides from March 3, 2009 Open Microphone Web Meeting #1 (30–Apr–2009)
- USP Proposes New Standards for Heparin to Protect Patients in Response to Recent Adulteration (04–Feb–2009)
- USP Announces New Standards to Protect Patients from Counterfeit and Adulterated Medicines (04–Feb–2009)
- Heparin Ad Hoc Advisory Panel Recommendations (17–Dec–2008)
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