In order to ensure the quality of heparin products and prevent potential contamination, the USP committee decided to adopt a new production control method for heparin. The revised USP standards have come into effect on October 1.
It is understood that the revised USP Reference Standard for heparin sodium and the definition of heparin unit have reduced the potency by 10% compared with that before the revision. U.S. manufacturers must label the amount of heparin contained in their products in accordance with USP standards. The revision of the pharmacopoeia standard of heparin products also includes new identification method, implementation of new potency determination method, additional impurity test, and consistency of heparin titer unit with international unit. In addition, heparin anticoagulant solution, human antithrombin III, heparin calcium, heparin calcium injection, heparin rinse solution and protamine sulfate were also revised. The United States Pharmacopoeia adopted a new method to evaluate the heparin titer. The chromogenic anti IIA factor test was used to replace the sheep plasma method in the previous Pharmacopoeia to determine the heparin titer. The high specificity of this method can provide further safety guarantee for the purity of heparin, and identify the potential counterfeit heparin which could not be identified by sheep plasma method in previous Pharmacopoeia. These revisions will also improve the purity of heparin and improve the results of potency determination and identification tests. Prescription drugs and OTC on the U.S. market must also meet the published standards of the USP.
According to the FDA's announcement, there are four major heparin and salt manufacturers in the United States, the largest of which is app pharmaceutical company, which sells heparin and its salt in tubular bottles; Hospira company sells heparin and its salt in venous bags, tubular bottles and syringes; Baxter International Limited and Braun Medical Co., Ltd. sell heparin and its salts in intravenous bags. FDA requires all pharmaceutical companies to be able to identify and differentiate their new products to help pharmacies and healthcare professionals distinguish between new and old standard products.