Glycosaminoglycans and Carbohydrates

Standards Updates

Official in USP 40 - NF 35, published Nov 1, 2016Official Date: May 1, 2017

Documentary Standards Associated Reference Standards

Heparin Sodium

Adenosine # 1012123

Oversulfated Chondroitin Sulfate # 1133580

Dermatan Sulfate # 1171455

Galactosamine Hydrochloride #1287722

Glucosamine Hydrochloride #1294207

Heparin Sodium for Assays #1304016

Heparin Sodium Identification #1304038

Heparin Sodium Molecular Weight Calibrant #1304107

Protamine Sulfate
Protamine Sulfate Injection

Protamine Sulfate #1578612
Heparin Sodium for Assays  #1304016

Official in USP 40 - NF 35, published June 1, 2017Official Date: Dec 1, 2017

Documentary Standards Associated Reference Standards

Fondaparinux Sodium

Fondaparinux Sodium Injection

Fondaparinux Sodium for Assay #1282707

Fondaparinux Sodium Identification #1282718

Fondaparinux Sodium System Suitability Mixture A #1282729  

Fondaparinux Sodium System Suitability Mixture B #1282730

Reference Standards

Reference Standards Status

Dermatan Sulfate

Released

Oversulfated Chondroitin Sulfate  #1133580

Dextran 10 Calibration  #1179865

Dextran 4 Calibration  #1179854

Dextran 40  #1179708

Dextran 70 System Suitability  #1179763

Dextran Vo Marker  #1179800

Released

Proposed New/Revised Monographs

Documentary Standards Associated Reference Standards

Acarbose Tablets

Proposed new monograph targeted to appear for public comment in Pharmacopeial Forum 43(5), to be posted September 1, 2017. This monograph will use 2 USP reference standards:

Acarbose #1000521

Acarbose System Suitability Mixture #1000532

For more information, contact Dr. Kamalpreet Arora at kta@usp.org

Heparin Updates

Heparin Labeling Clarification (11–Nov–2017): The labeling sections of the currently official Heparin Sodium Injection and Heparin Lock Flush Solution monographs in USP–NF will be proposed for revision in PF 44(1), posted January 2, 2018, with comments due March 31, 2018. This proposed revision will maintain consistency with the text in USP General Chapter <7> Labeling also proposed for revision in PF 44(1).

Note that heparin-related labeling, e.g. on the containers, need not use the full phrase “USP Heparin Units” that appears in many heparin monograph labeling sections. The term “USP units” can be used on heparin labeling consistent with USP compendial requirements, provided it is clear from the context that the volume is stated in terms of USP Heparin Units. In such circumstances it should be clear that “USP Units” and “USP Heparin Units” share the same meaning.

New Reference Standards Releases

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Glycosaminoglycan and Carbohydrate Standards–Collaborate with USP

Building on the experience in setting standards for heparin products, USP continues to develop standards that are applicable to glycosaminoglycan and carbohydrate products.  Additional standards for critical reagents are under consideration.  Comments and queries should be addressed to gagcarbos@usp.org.

Our work with glycosaminoglycans and carbohydrates is guided by scientific experts from a variety of disciplines and industries. Find out what this Expert Committee is up to by reviewing its workplan: