Rosuvastatin Calcium is a synthetic lipid-regulating active pharmaceutical ingredient belonging to the statin class of medicines. It is the calcium salt of rosuvastatin and acts as an HMG-CoA reductase inhibitor. Rosuvastatin Calcium is widely used in pharmaceutical formulations intended to reduce elevated cholesterol and manage dyslipidemia. The API is particularly important in the development and manufacture of oral solid dosage forms such as tablets.
Rosuvastatin Calcium is supplied as a defined calcium salt containing two rosuvastatin anions for each calcium ion. Its chemical formula is C₄₄H₅₄CaF₂N₆O₁₂S₂, with a molecular weight of 1001.14 g/mol. The CAS Number is 147098-20-2. PubChem and USP identify this CAS specifically with Rosuvastatin Calcium.
The API is generally described as a white to almost white or off-white powder. The European Pharmacopoeia describes it as a white or almost white, hygroscopic powder. Its solubility characteristics include slight solubility in water and greater solubility in selected organic solvents.
Rosuvastatin Calcium is a chiral pharmaceutical substance containing defined stereochemistry. Control of stereochemical purity is therefore an important component of pharmaceutical quality testing. The API contains the characteristic fluorophenyl and pyrimidine structural groups associated with rosuvastatin and is manufactured for use as a pharmaceutical active ingredient.
The pharmacological action of rosuvastatin results from competitive inhibition of hepatic HMG-CoA reductase, an enzyme involved in cholesterol biosynthesis. This mechanism contributes to reduction of LDL cholesterol and other lipid parameters and supports its use in lipid-regulating pharmaceutical products.
Rosuvastatin Calcium API is primarily used in the manufacture of oral pharmaceutical formulations. It is incorporated into rosuvastatin tablets available in different strengths. Regulatory product information identifies rosuvastatin calcium as the active substance used in tablets containing rosuvastatin equivalent to commonly marketed strengths such as 5 mg, 10 mg, 20 mg and 40 mg.
For pharmaceutical manufacturers, API quality is particularly important because rosuvastatin calcium is sensitive to environmental conditions and the related-substance profile must be carefully controlled during manufacturing, processing and storage.
Quality control of Rosuvastatin Calcium includes identity testing, assay, enantiomeric purity, related-substance analysis and water determination. The current USP monograph specifies 97.0%–103.0% rosuvastatin calcium on an anhydrous and solvent-free basis. USP also specifies NMT 6.0% water.
Current USP impurity controls include Rosuvastatin Related Compound A NMT 0.2%, rosuvastatin diastereomers NMT 0.5%, and rosuvastatin enantiomer NMT 0.15%. The Ph. Eur. monograph additionally specifies controls for several identified and unspecified related substances.
Rosuvastatin Calcium API is manufactured for pharmaceutical formulation and development applications with appropriate analytical testing and quality documentation. Pharmaceutical manufacturers can require batch-specific documentation such as Certificate of Analysis, specification sheets, Safety Data Sheets and regulatory documentation according to market and customer requirements.
Rosuvastatin Calcium should be protected from light and moisture and stored under controlled conditions. The USP monograph specifies preservation in well-closed containers, protected from light, at controlled room temperature. The Ph. Eur. material also emphasizes appropriate protection during storage.
Rosuvastatin Calcium is an established statin API with recognized USP and Ph. Eur. quality standards. Consistent control of assay, water content, related substances and stereochemical purity helps support reliable pharmaceutical manufacturing and formulation development.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 97.0% – 103.0% |
| Individual Impurity | NMT 0.2% |
| Water Content | NMT 6.0% |