About Atorvastatin Calcium Api
Atorvastatin belongs to the group of medicines called
HMG-CoA reductase inhibitors, or statins. It works by blocking an enzyme that is needed by the body to make cholesterol, and this reduces the amount of cholesterol in the blood. This medicine is available only with your doctor's prescription.
Quality and StabilityAtorvastatin Calcium API is rigorously tested for key quality indicators, including microbial limits, related substances, residual solvents, and heavy metals (10 ppm), ensuring it complies with pharmacopeial standards. Its stability under recommended storage conditions safeguards efficacy and shelf life, making it ideal for pharmaceutical applications.
Versatile Packaging OptionsPackaged in secure drums or bags, Atorvastatin Calcium API is optimized for transportation and storage. These packaging options protect the material from moisture, contamination, and light exposure, maintaining product integrity during global export and local supply.
Pharmaceutical ApplicationAs a raw material in the manufacture of lipid-lowering agents, Atorvastatin Calcium API is essential in the production of medications that manage cholesterol levels. Its consistent particle size and solubility profile ensure reliable drug formulation and patient outcomes.
FAQ's of Atorvastatin Calcium Api:
Q: How should Atorvastatin Calcium API be stored to maintain its stability?
A: Atorvastatin Calcium API should be stored in a cool, dry place away from direct sunlight to preserve its stability and prevent degradation.
Q: What is the primary usage of Atorvastatin Calcium API?
A: This API is primarily used as a pharmaceutical raw material in the formulation of lipid-lowering agents, which help control cholesterol levels.
Q: When is Atorvastatin Calcium API considered compliant with quality standards?
A: The API meets quality standards when it complies with pharmacopeial limits on microbial content, related substances, loss on drying, heavy metals, and ICH guidelines for residual solvents.
Q: Where is Atorvastatin Calcium API exported from and what are its typical export markets?
A: Atorvastatin Calcium API is exported globally from India, serving pharmaceutical manufacturers and suppliers worldwide.
Q: What processes are involved in manufacturing Atorvastatin Calcium API?
A: This API is manufactured through either fermentation or synthetic processes, ensuring high purity and consistency suitable for pharmaceutical use.
Q: How is product identification for Atorvastatin Calcium API confirmed?
A: Identification is confirmed by using IR spectroscopy or UHPLC techniques, as specified in pharmacopeia guidelines.
Q: What are the benefits of using Atorvastatin Calcium API in pharmaceutical formulations?
A: The API offers high stability, consistent particle size, and compliance with stringent quality standards, ensuring reliable and effective lipid-lowering medications.