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ATORVASTATIN CAL IP/USP

Name: ATORVASTATIN CAL IP/USP
Brand: IPSUM LIFESCIENCES LLP
Price: 1800 INR
Availability: InStock

Price 1800 INR/ Kilograms

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MOQ : 25 Kilograms

ATORVASTATIN CAL IP/USP Specification

Loss on Drying
0.5%

Heavy Metal (%)
0.001%

Molecular Weight
1209.42 g/mol

Place of Origin
India

Molecular Formula
C66H68CaF2N4O10

HS Code
29420090

Moisture (%)
0.5%

Residue on Ignition
0.1%

Melting Point
159-160C

Assay
>99%

Storage
Store In Cool & Dry Place, Protect From Light

Particle Size
Micronized

Other Names
Atorvastatin Calcium

CAS No
134523-03-8

Type
Pharmaceutical Raw Material

Grade
Pharmaceutical Grade

Usage
Cholesterol Lowering Agent, Used In Antihyperlipidemic Formulations

Purity
>99%

Appearance
White To Off-White Powder

Application
Active Pharmaceutical Ingredient (API) For Tablet, Capsule Manufacturing

Raw Material
Yes

Smell
Odorless

Color
White To Off White

Form
Powder

Solubility
Freely Soluble In Methanol & Ethanol; Practically Insoluble In Water

Specific Optical Rotation
+37 to +41

Microbial Limits
Complies With IP/USP Standards

Identification
Complies With IP/USP Standards

USP Reference Standard
Meets USP/EP/USP Standards

Packaging Type
HDPE Drum With Double Polybag

Stability
Stable Under Recommended Storage Conditions

Shelf Life
3 Years From Manufacturing Date

Impurities
Total Impurities 0.5%

About ATORVASTATIN CAL IP/USP

Atorvastatin calcium, as per IP (Indian Pharmacopoeia) and USP (United States Pharmacopeia) specifications, ensures its quality, potency, and safety for pharmaceutical use. These standards define its identity, purity, strength, and allowable limits for impurities and contaminants. They also specify parameters like assay (potency), related substances, residual solvents, moisture content (loss on drying), heavy metals content, microbial limits, particle size distribution, and storage conditions. Compliance with these specifications guarantees Atorvastatin calcium's reliability and effectiveness in medical applications.

Exceptional Purity and Quality Standards

Atorvastatin Calcium IP/USP is manufactured under stringent pharmaceutical standards to ensure purity levels exceeding 99%. Each batch is thoroughly tested for heavy metals, impurities, and microbial content, in line with IP, USP, and EP requirements. The material remains stable under proper storage conditions, providing consistent efficacy for medication production.

Optimized Formulation for Pharmaceutical Manufacturing

This raw material is offered in micronized powder form for ease of incorporation into tablet and capsule formulations. The free solubility in methanol and ethanol ensures seamless blending in various pharmaceutical processes, while its practical insolubility in water aids in targeted formulation needs.

Reliable Packaging and Shelf Life

Packaged in HDPE drums with double polybags, Atorvastatin Calcium is safeguarded against moisture and contaminant exposure. With a shelf life of three years from the date of manufacturing, it remains potent and stable, provided it is stored in a cool, dry, and light-protected environment.

FAQ's of ATORVASTATIN CAL IP/USP:

Q: How should Atorvastatin Calcium IP/USP be stored to maintain its stability?

A: Atorvastatin Calcium IP/USP should be stored in a cool and dry place, away from direct light and moisture. Keeping it in its original HDPE drum with double polybag packaging helps preserve its quality and extends its shelf life to three years.

Q: What is the typical process for incorporating Atorvastatin Calcium into pharmaceutical formulations?

A: Due to its micronized powder form and free solubility in methanol and ethanol, Atorvastatin Calcium can be readily blended into antihyperlipidemic tablet and capsule formulations as an active pharmaceutical ingredient using standard pharmaceutical manufacturing techniques.

Q: When does the product expire and how long is its shelf life?

A: The shelf life of Atorvastatin Calcium IP/USP is three years from the manufacturing date, provided storage recommendations are followed to protect its potency and efficacy.

Q: Where is this Atorvastatin Calcium manufactured and supplied from?

A: This pharmaceutical-grade Atorvastatin Calcium is manufactured, supplied, and traded by reputable sources in India, complying with strict international standards for quality and purity.

Q: What are the benefits of using Atorvastatin Calcium IP/USP in antihyperlipidemic formulations?

A: Atorvastatin Calcium IP/USP exceeds 99% purity and meets all IP/USP standards, ensuring high efficacy and safety when used as an API for cholesterol-lowering medications. Its low impurity levels and stable properties make it ideal for reliable pharmaceutical production.

Q: How can Atorvastatin Calcium IP/USP be identified and verified for compliance?

A: Each batch of Atorvastatin Calcium undergoes detailed identification and verification processes to ensure compliance with IP/USP standards, including checks for specific optical rotation, assay, impurity profile, and microbial limits.

Q: What is the main usage of Atorvastatin Calcium IP/USP?

A: Atorvastatin Calcium IP/USP is primarily used as an active pharmaceutical ingredient (API) in the manufacturing of tablets and capsules designed to help lower cholesterol and manage lipid levels in patients.

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