[Collaborative study of Japanese Pharmacopoeia Heparin Sodium Reference Standard (Control 871)]

Heparin Sodium Reference Standard for Japanese Pharmacopoeia (JP) is replaced with new material derived from porcine mucosa. The material was dissolved in water, distributed to vials and freeze-dried. The anticoagulant activity of the freeze-dried product was determined in collaboration with four laboratories employing JP method. The weighted mean potency of 101 assays was 1515 international units per vial, and this value was adopted for the potency of new JP Heparin Sodium Reference Standard (Control 871). By the antiheparin test of protamine sulfate, 0.712 mg of the new standard was neutralized by 1 mg of protamine sulfate. Molecular weight distribution of this standard was also measured by means of gel permeation chromatography and compared with those of the former reference standard and bovine heparin.