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 |
Reference Standards
| Reference Standards | Status |
|---|---|
|
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.
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 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: