The GENERAL CHAPTERS of the United States Pharmacopeia and the National Formulary (USP-NF 2023 ISSUE 3*) includes "<209> Low Molecular Weight Heparin Molecular Weight Determinations". The molecular weight measurement of low molecular weight heparin is carried out with a gel permeation chromatography column filled with L59 packing material and meets following requirement. The use of aqueous SEC (GFC) columns, PROTEIN KW-803 and KW-802.5 connected to their guard column KW-G 6B, confirmed the requirements were met.

System suitability requirement

1. (1)When analyzing USP Low Molecular Weight Heparin Molecular Weight Calibrant RS, the last eluting peak of low molecular weight heparin (LMWH) and the sodium salt peak (or minus peak) are baseline separated.
2. (2)When applying a cubic equation approximation to the calibration curve, the coefficient of determination must be 0.990 or more.
3. (3)When analyzing the USP LMWH standard sample, the measured weight average molecular weight (Mw) must be within 150 Da of the Mw listed on the certificate.
   *In this application, USP Dalteparin Sodium RS was used as a LMWH standard sample.

*The version at the time of the application acquisition.

Sample: 20 μL
5.03 mg/mL of USP Low Molecular Weight Heparin Molecular Weight Calibrant RS in eluent

1.  

Sample: 20 μL
(System suitability solution) 5.0 mg/mL of USP Dalteparin Sodium RS in eluent

1.