According to the United States Pharmacopeia and the National Formulary, ”Molecular Weight Measurements of Low Molecular Weight Heparins by Gel Permeation Chromatography"<209> LOW MOLECULAR WEIGHT HEPARIN MOLECULAR WEIGHT DETERMINATIONS" should be carried out with two analytical columns and their guard column filled with L59 packing material. PROTEIN KW-803, KW-802.5, and KW-G 6B (guard column) filled with L59 packing material, in series confirmed the requirements were met.

System suitability requirementsResolution (System suitability solution): The last eluting peak of USP Low Molecular Weight Heparin (LMWH) Molecular Weight Calibrant RS and the sodium salt peak (or minus peak) are baseline separated.
Coefficient of determination of the calibration curve, using a third-order polynomial equation (Calibration solution): ≥ 0.990
Weight average molecular weight (M_w) (System suitability solution): Indicated in the product monograph. The measured weight average molecular weight (M_w) of USP Dalteparin Sodium RS must be within 150 Da of the Mw listed on the certificate.

*The version at the time of the application acquisition.

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

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

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