Atorvastatin calcium USP/BP/EP is a high-quality pharmaceutical-grade active pharmaceutical ingredient (API) designed for use in the manufacture of cholesterol-lowering medications. This compound is utilized primarily for reducing elevated cholesterol and triglyceride levels in the blood, thereby assisting in the prevention of cardiovascular diseases such as heart attack, stroke, and angina. Manufactured in compliance with United States Pharmacopeia (USP), British Pharmacopeia (BP), and European Pharmacopeia (EP) standards, this atorvastatin calcium ensures consistent purity and efficacy. It works by inhibiting the HMG-CoA reductase enzyme to decrease the production of cholesterol in the liver and is ideal for pharmaceutical companies and laboratories focused on producing effective lipid-lowering treatment formulations in compliance with global pharmacopeial guidelines.
Key Features
| Features | Description |
|---|---|
| Pharmacopoeial Standards | USP/BP/EP certified, ensuring high purity and quality |
| Active Ingredient | Atorvastatin calcium, a potent HMG-CoA reductase inhibitor |
| Therapeutic Use | Lowers cholesterol and triglycerides to prevent cardiovascular diseases |
| Application | For pharmaceutical formulation of cholesterol-lowering drugs |
| Purity | High-grade API meeting stringent global pharmacopeial specifications |
| Safety | Manufactured under GMP to ensure safety for drug formulation |
| Form | Powdered form for easy incorporation into solid oral dosage forms |
| Packaging | Supplied in sealed containers suitable for bulk pharmaceutical use |
| Attributes | Description |
|---|---|
| Chemical Name | Atorvastatin calcium |
| Molecular Formula | C66H68CaF2N4O10 |
| Molecular Weight | Approximately 1209.42 g/mol |
| Appearance | White to off-white crystalline powder |
| Assay | Not less than 99.0% and not more than 101.0% |
| Solubility | Practically insoluble in water |
| Loss on Drying | Not more than 2.0% |
| Identification | Matches USP/BP/EP standards by spectroscopy and chromatography |
| Heavy Metals | Less than 20 ppm |
| Residual Solvents | Complies with ICH Q3C guidelines |
*Disclaimer: The above description has been AI-generated and has not been audited or verified for accuracy. It is recommended to verify product details independently before making any purchasing decisions.
Yes, the atorvastatin calcium is certified to meet USP, BP, and EP standards, ensuring it conforms to internationally recognized quality benchmarks.
It is used as the active ingredient in the manufacture of oral dosage forms aimed at lowering blood cholesterol and triglycerides, helping prevent cardiovascular diseases.
The product undergoes strict quality control including assay, identification, and impurity checks in line with USP/BP/EP requirements to guarantee purity levels between 99.0% and 101.0%.
It should be stored in a cool, dry place away from light and moisture to maintain stability and efficacy, as detailed in pharmacopeial guidelines.
Yes, given it complies with BP and EP standards along with USP, it is suitable for export to markets that require these certifications.
Atorvastatin is used together with a proper diet to lower cholesterol and triglyceride (fats) levels in the blood. This medicine may help prevent medical problems (eg, chest pain, heart attack, or stroke) that are caused by fats clogging the blood vessels.
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