Statin "Top Stream" is Coming - Rosuvastatin Impurities Supply

Rosuvastatin Calcium is a statin lipid-lowering drug, a selective and competitive HNG-CoA reductase inhibitor, which lowers blood levels of total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C) by decreasing the synthesis and storage of cholesterol by hepatocytes. It is mainly used for the treatment of hypercholesterolaemia, simple hypertriglyceridemia and disorders of lipid metabolism. In August 2003, it was approved for marketing by the US FDA.

The impurity study in its synthesis and quality control is an important part to ensure the safety and efficacy of the drug. Domestic and foreign pharmacopoeias have recorded the impurities of Rosuvastatin calcium, among which, the European Pharmacopoeia (EP11.0) has labelled a total of 12 Rosuvastatin calcium impurities A-M, clarified the relative retention time of the following impurities and carried out individual quantitative control of impurity A, impurity B, impurity C, impurity G, and impurities D, K, and M; The United States Pharmacopoeia (USP2024) also has clear standards for relative retention times and limits for some impurities.

Rosuvastatin EP impurity B, the diastereoisomer of Rosuvastatin, is produced in large amounts under acidic conditions and to a lesser extent under strong alkaline, high temperature and oxidising conditions. Rosuvastatin EP impurity D is produced in large quantities under acidic and alkaline conditions and to a lesser extent under prolonged storage.

Impurity studies of Rosuvastatin and its calcium salt cover a wide range of aspects from synthesis and detection to quality control. The use of quality-standardised pharmaceutical impurity controls/standards is essential for controlling impurities in Rosuvastatin Calcium to ensure its safety and efficacy as a drug for the treatment of cardiovascular diseases.

SZEB  has its own brand of impurity controls--SZEB, with more than 100,000 products in stock, tens of thousands of impurity controls and pharmacopoeia standards from various countries, with a complete range of purity guaranteed. Now we have the advantage of supplying Rosuvastatin impurity .

For more information about drug impurity control products, please go to the official website:www.ex-biotech.com