3-Oxo Atorvastatin: From Impurity to Essential Pharmaceutical Intermediate
In the intricate world of pharmaceutical chemistry, certain compounds hold a dual significance, serving not only as critical building blocks but also as important indicators of process integrity. 3-Oxo Atorvastatin (CAS 887196-30-7) exemplifies this duality, being both a key pharmaceutical intermediate and a notable impurity in the synthesis of Atorvastatin, a widely prescribed medication for cardiovascular health.
Understanding the nature of 3-Oxo Atorvastatin is crucial for anyone involved in the Atorvastatin manufacturing process. Chemically, it is represented by the molecular formula C33H33FN2O5 and has a molecular weight of approximately 556.62 g/mol. Its structure features a characteristic β-keto group at the 3-position, distinguishing it from the primary Atorvastatin molecule. This structural difference makes it a detectable entity that requires careful management.
As an impurity, 3-Oxo Atorvastatin is a byproduct that can arise during the complex multi-step synthesis of Atorvastatin calcium. Regulatory guidelines, such as those from the European Pharmacopoeia (EP) and the United States Pharmacopeia (USP), set strict limits on the acceptable levels of such impurities in finished pharmaceutical products. Consequently, pharmaceutical companies require access to high-purity 3-Oxo Atorvastatin to serve as a reference standard. This standard is indispensable for developing and validating analytical methods, like HPLC and LC-MS, used to accurately quantify its presence in Atorvastatin batches, thereby ensuring drug safety and compliance. Professionals often search to buy 3-oxo atorvastatin manufacturer China to ensure they receive certified reference materials.
Beyond its role in quality control, 3-Oxo Atorvastatin also functions as a valuable pharmaceutical intermediate. Researchers and chemists utilize it in various R&D activities. This includes studying the degradation pathways of Atorvastatin, investigating its metabolic profile, and developing more efficient synthetic routes for the API. The ability to obtain this compound from a reliable supplier in China facilitates such critical research, enabling advancements in drug development and manufacturing processes. Many institutions choose to order 3-oxo atorvastatin from reputable manufacturers for their research needs.
As a leading manufacturer of 3-oxo atorvastatin, our commitment is to provide the pharmaceutical industry with a product of exceptional quality and purity, typically exceeding 98%. We understand that consistent supply and adherence to quality standards are paramount for our clients. Whether you are a pharmaceutical manufacturer needing bulk quantities for process optimization or a research laboratory requiring analytical standards, our facility is equipped to meet your demands. We offer competitive pricing for 3-oxo atorvastatin, making it accessible for a wide range of applications.
In conclusion, 3-Oxo Atorvastatin is a compound of significant importance in the pharmaceutical sector. Its dual role as a controlled impurity and a useful intermediate highlights the need for reliable sourcing. By choosing a trusted pharmaceutical intermediate supplier, you ensure the quality, safety, and efficiency of your operations. We invite you to explore our offerings and experience the difference that high-quality, consistently produced chemical compounds can make.
Perspectives & Insights
Molecule Vision 7
“As an impurity, 3-Oxo Atorvastatin is a byproduct that can arise during the complex multi-step synthesis of Atorvastatin calcium.”
Alpha Origin 24
“Regulatory guidelines, such as those from the European Pharmacopoeia (EP) and the United States Pharmacopeia (USP), set strict limits on the acceptable levels of such impurities in finished pharmaceutical products.”
Future Analyst X
“Consequently, pharmaceutical companies require access to high-purity 3-Oxo Atorvastatin to serve as a reference standard.”