Understanding Rosuvastatin Calcium: A Key Pharmaceutical Intermediate
The pharmaceutical industry relies on a complex network of intermediates to synthesize life-saving medications. Among these, Rosuvastatin Calcium stands out as a critical pharmaceutical intermediate, primarily used in the production of the widely prescribed cholesterol-lowering drug, Rosuvastatin. For R&D scientists and procurement specialists, understanding the characteristics and sourcing requirements of this compound is essential for successful drug development and manufacturing.
What is Rosuvastatin Calcium?
Rosuvastatin Calcium is the calcium salt form of Rosuvastatin, an HMG-CoA reductase inhibitor. Its primary function is to reduce elevated levels of cholesterol and triglycerides in the blood, thereby mitigating the risk of cardiovascular diseases. As a pharmaceutical intermediate, it serves as a precursor or key building block in the synthesis of the final active pharmaceutical ingredient (API) or the finished dosage form. The compound is typically supplied as a white powder, with high purity levels (often exceeding 99%) being a critical specification for its intended use.
Key Specifications and Quality Parameters
When sourcing Rosuvastatin Calcium, several technical specifications are paramount. The CAS number, 147098-20-2, uniquely identifies this chemical compound. Beyond its appearance as a white powder, buyers must look at the assay result, which indicates the actual content of Rosuvastatin Calcium, typically specified to be within a narrow range of 98.0% to 102.0%. Other vital parameters include limits for heavy metals and residue on ignition, as well as loss on drying, all of which are detailed in the Certificate of Analysis (CoA). For pharmaceutical applications, adherence to pharmacopoeial standards (USP, BP) and GMP manufacturing practices by the supplier is non-negotiable. If you are looking to buy this intermediate, ensuring these specifications are met is crucial for regulatory compliance.
Applications and Importance in Drug Synthesis
The principal application of Rosuvastatin Calcium is in the synthesis of Rosuvastatin, a medication used to treat hyperlipidemia and reduce the risk of cardiovascular events. Its effectiveness in lowering LDL cholesterol and raising HDL cholesterol makes it a highly sought-after API. Pharmaceutical manufacturers that produce generic or branded Rosuvastatin formulations depend on a consistent and high-quality supply of this intermediate. Therefore, a reliable manufacturer and supplier are vital for companies that purchase this chemical. Its role in creating life-saving drugs underscores the importance of its purity and availability.
Sourcing Strategies for Pharmaceutical Buyers
Procuring pharmaceutical intermediates like Rosuvastatin Calcium requires a strategic approach. Buyers should identify manufacturers that specialize in APIs and intermediates and possess robust quality management systems. Engaging with suppliers who can provide comprehensive documentation, such as CoAs and regulatory support, is essential. When considering purchasing from China, it is advisable to conduct thorough due diligence on potential suppliers, checking their certifications, production capacity, and payment and shipping terms. Obtaining samples for in-house testing before placing large orders is also a standard and recommended practice. A dependable supplier ensures not only the quality of the intermediate but also the smooth progression of your drug development pipeline.
Perspectives & Insights
Silicon Analyst 88
“Key Specifications and Quality ParametersWhen sourcing Rosuvastatin Calcium, several technical specifications are paramount.”
Quantum Seeker Pro
“Beyond its appearance as a white powder, buyers must look at the assay result, which indicates the actual content of Rosuvastatin Calcium, typically specified to be within a narrow range of 98.”
Bio Reader 7
“Other vital parameters include limits for heavy metals and residue on ignition, as well as loss on drying, all of which are detailed in the Certificate of Analysis (CoA).”