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United States Pharmacopoeia announces new liver quality standards

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In order to ensure the quality of heparin products and prevent potential contamination, the United States Pharmacopoeia Commission has decided to adopt new manufacturing control methods for heparin. The revised United States Pharmacopoeia standards were published and took effect on October 1.

It is understood that the revised United States Pharmacopoeia reference standard for heparin sodium and the heparin sodium unit definition are 10% lower than the pre-revised titer. U.S. manufacturers must label the heparin dose contained in their products in accordance with U.S. Pharmacopoeia standards. This revision of the pharmacopoeia standard for heparin products also includes new identification methods, implementation of new titer methods and additional impurity tests, and consistency of heparin titer units with international units. In addition, several contents of 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 for the titer assessment of heparin, using chromogenic anti-IIA factor assay instead of sheep plasma assay in the previous pharmacopoeia. The highly specific performance of this assay is sufficient to provide further safety assurance for the purity of heparin, and to identify potential counterfeit drugs similar to heparin that could not previously be identified by sheep plasma method in pharmacopoeia. These revisions will also improve the purity of heparin and the results of titer determination and identification tests. Prescription drugs and OTC products sold in the United States must also meet the public standards of the United States Pharmacopoeia.

According to the FDA, there are four major manufacturers of heparin and its salt in the United States. The largest is APP Pharmaceuticals, which sells tubular bottles of heparin and its salt. Hospira sells heparin and its salt in iv bags, tube bottles and syringes; Baxter International Inc. and Braun Medical inc. sell intravenous bags of heparin and its salts. FDA requires all drugmakers to be able to identify and differentiate their new products to help pharmacies and healthcare professionals distinguish new standard products from old standard products.

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