Glycosaminoglycans and Carbohydrates

Standards Updates

Official in USP 40–NF 35, as of 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

New 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 are now posted in PF 44(1), 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.

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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 biotech@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: