Rosuvastatin Calcium
Pharmaceutical Premium
Pharmaceutical API

Rosuvastatin Calcium

High-purity pharmaceutical grade Rosuvastatin Calcium manufactured to meet stringent USP/EP specifications for pharmaceutical formulations and research applications. Our pharmaceutical grade material delivers exceptional purity and consistency for critical pharmaceutical manufacturing.

  • USP/EP Grade Specifications
  • High Purity (≥99.0%)
  • Comprehensive Analytical Testing
  • Regulatory Compliance Documentation
  • Pharmaceutical Manufacturing Grade
  • Quality Assurance Certified
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Technical Specifications

Chemical Formula: (C22H27FN3O6S)2·Ca
CAS Number: 147098-20-2
EINECS Number: Not applicable
Purity (HPLC): ≥99.0% (USP/EP Grade)
Physical State: White to off-white amorphous powder
Molecular Weight: 1001.14 g/mol
Melting Point: 122-125°C
pH (1% solution): 6.0-8.0
Loss on Drying: ≤1.0%
Residue on Ignition: ≤0.2%
Heavy Metals: ≤10 ppm
Solubility: Slightly soluble in water
Storage Conditions: Store at 15-30°C, protect from light
Shelf Life: 3 years from manufacture date
Packaging Options: 100g, 500g, 1kg containers

Applications

Hypercholesterolemia
Cholesterol Reduction
Oral Tablet Formulations
Extended-Release Formulations
HMG-CoA Reductase Inhibitor
Cardiovascular Protection
Lipid Management
Atherosclerosis Prevention
Cardiovascular Research
Clinical Trials
Statin Drug Development
Pharmaceutical Research

Industry-Specific Grades

DRAVYOM offers specialized Rosuvastatin Calcium grades tailored for specific cardiovascular applications, ensuring optimal HMG-CoA reductase inhibitor activity and regulatory compliance across diverse pharmaceutical formulations.

USP Grade (United States Pharmacopoeia)
Purity: ≥99.0% Water Content: ≤1.0% Heavy Metals: ≤10 ppm Application: FDA approved formulations
EP Grade (European Pharmacopoeia)
Purity: ≥99.0% Related Substances: ≤1.0% Residual Solvents: EP limits Application: European market compliance
Research Grade
Purity: ≥98.0% Activity: Verified Stability: Enhanced Application: Cardiovascular research
Lipid Management Grade
Purity: ≥99.5% Bioavailability: Optimized Efficacy: Enhanced Application: Cholesterol therapy

Quality Standards

DRAVYOM's Rosuvastatin Calcium is manufactured under stringent cGMP protocols, meeting international pharmaceutical standards including USP, EP, and FDA guidelines for cardiovascular therapy applications.

cGMP Manufacturing Standards
USP/EP Grade Specifications
≥99.0% HPLC Purity
Advanced Analytical Testing
Statin Activity Verified
Batch-to-Batch Consistency
Comprehensive COA Documentation
Controlled Storage & Shipping

Advanced Chemical Properties & Performance

Pharmaceutical Grade Rosuvastatin Calcium exhibits exceptional chemical properties essential for cholesterol management applications. Its potent HMG-CoA reductase inhibitor structure and superior stability characteristics ensure reliable performance in demanding cardiovascular disease prevention formulations.

Molecular Properties
Molecular Weight: 1001.14 g/mol (calcium salt)
Molecular Formula: (C22H27FN3O6S)2Ca
LogP (Octanol/Water): -0.33
pKa: 4.6
Physical Properties
Melting Point: 122-126°C
Appearance: White to off-white amorphous powder
Solubility (Water): Freely soluble
Bulk Density: 0.45-0.55 g/cm³
Pharmaceutical Properties
Bioavailability: 20%
Protein Binding: 88%
Half-life: 19 hours
Mechanism: HMG-CoA reductase inhibition
Quality Specifications
Purity (HPLC): ≥99.0%
Water Content: ≤0.5%
Related Substances: ≤1.0%
Heavy Metals: ≤10 ppm
Stability Properties
Shelf Life: 3 years (unopened)
Storage Temperature: 15-25°C
Light Sensitivity: Store in light-resistant containers
Moisture Sensitivity: Store in dry conditions

Performance Characteristics

Detailed performance metrics demonstrate Rosuvastatin Calcium superiority in cholesterol management applications with exceptional HMG-CoA reductase inhibition, potent LDL reduction, and therapeutic efficacy across diverse cardiovascular disease prevention protocols.

HMG-CoA Reductase Inhibition

Potent and selective enzyme inhibition

Superior cholesterol synthesis inhibition
LDL Cholesterol Reduction

Significant reduction in LDL cholesterol levels

Up to 63% LDL reduction
Cardiovascular Protection

Effective cardiovascular event prevention

Primary and secondary prevention
Extended Half-life

19-hour elimination half-life

Once-daily dosing convenience
Clinical Efficacy

FDA-approved for hypercholesterolemia

Proven cardiovascular benefits
Dose Flexibility

Wide dosing range for individualized therapy

5-40 mg dose options

Safety Information

Pharmaceutical active ingredient requiring careful handling protocols. Handle in controlled environments with appropriate ventilation systems. Use proper personal protective equipment and follow established safety protocols for statin compounds.

Active Pharmaceutical Ingredient
Controlled Handling Required
Standard PPE Required

Storage & Handling

Store in tightly closed, light-resistant containers in a cool, dry place away from direct sunlight. Maintain controlled room temperature storage and ensure protection from moisture and humidity to preserve pharmaceutical quality and statin potency.

Controlled room temperature (15-25°C)
Protect from light
Light-resistant containers
Store in dry conditions

Chemical Mechanisms & Reaction Pathways

Rosuvastatin Calcium exhibits specific HMG-CoA reductase inhibitor mechanisms essential for cholesterol lowering therapy. Its molecular structure enables selective enzyme inhibition with predictable lipid-lowering therapeutic responses.

HMG-CoA Reductase Inhibition

Competitive inhibition of cholesterol biosynthesis rate-limiting enzyme

Cholesterol synthesis suppression
Metabolic Pathways

Hepatic metabolism via CYP2C9 and limited CYP2C19 pathways

Minimal drug-drug interactions
Hepatic Selectivity

Preferential liver uptake and cholesterol synthesis targeting

Targeted lipid modification
Pharmacological Effects

Potent LDL cholesterol reduction and pleiotropic effects

Cardiovascular protection

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures global pharmaceutical access with complete documentation packages supporting international drug development and manufacturing standards.

USP Specifications

United States Pharmacopeia pharmaceutical standards compliance

EP Standards

European Pharmacopoeia specifications for pharmaceutical quality

ICH Guidelines

International Conference on Harmonization standards compliance

GMP Certification

Good Manufacturing Practices certified production facility

DMF Support

Drug Master File documentation for regulatory submissions

CEP Available

Certificate of Suitability to European Pharmacopoeia monographs

Technical Support & Value-Added Services

DRAVYOM's pharmaceutical development team provides comprehensive formulation support, regulatory assistance, and technical services to optimize pharmaceutical performance in your specific drug development applications.

Formulation Development
  • Dosage form optimization support
  • Stability testing guidance
  • Bioavailability enhancement
  • Custom formulation development
Analytical Services
  • Method development and validation
  • Impurity profiling and identification
  • Stability indicating methods
  • Dissolution testing support
Regulatory Support
  • Regulatory submission assistance
  • DMF preparation and maintenance
  • Pharmacovigilance support
  • Global registration strategy
Supply Solutions
  • Pharmaceutical supply chain management
  • Cold chain logistics
  • Custom packaging solutions
  • Global distribution network

Environmental Impact & Sustainability

Our pharmaceutical production emphasizes environmental responsibility through sustainable manufacturing practices, green chemistry principles, and comprehensive environmental impact management for pharmaceutical operations.

Green Chemistry

Sustainable synthetic routes with minimal environmental impact

Water Management

Advanced wastewater treatment and recycling systems

Clean Production

Energy-efficient synthesis with emission controls

Safe Disposal

Comprehensive pharmaceutical waste management protocols

ISO 14001

Environmental management system certified production

Sustainable Packaging

Recyclable pharmaceutical packaging solutions

Manufacturing Excellence & Quality Control

DRAVYOM's state-of-the-art pharmaceutical manufacturing facility employs advanced synthesis technology and continuous monitoring systems to ensure consistent pharmaceutical quality and performance across all production batches.

Production Process

Advanced synthesis and purification in GMP-controlled clean-room environment

Multi-stage purification for pharmaceutical grade quality
Quality Testing

Comprehensive testing protocol including purity, potency, and impurity profiling

HPLC, GC-MS, and spectroscopic analysis
Quality Systems

ISO 9001:2015 and GMP quality management systems

Continuous improvement and validation protocols
Packaging Control

Pharmaceutical-grade packaging with controlled atmosphere

Contamination prevention and stability protection

Market Applications & Performance Data

Comprehensive pharmaceutical development data demonstrating effectiveness across diverse therapeutic applications with quantified performance metrics and clinical validation support.

Pharmaceutical Development
Formulation Success: 95+ formulations developed Regulatory Approvals: 100+ successful submissions Quality Consistency: 99.9% batch compliance
Research Applications
Clinical Studies: 200+ supported trials Publication Support: 150+ peer-reviewed papers Innovation: Custom API development
Commercial Manufacturing
Scale-up Success: 100% process transfers Supply Reliability: 99.8% on-time delivery Cost Optimization: 25% average cost reduction

DRAVYOM Competitive Advantages

Pharmaceutical Excellence

Consistently exceeds pharmacopeial specifications with superior purity and pharmaceutical performance

Reliable Supply

Guaranteed pharmaceutical availability with strategic inventory and GMP production scheduling

Development Expertise

Dedicated pharmaceutical development team provides formulation and regulatory support

Regulatory Assurance

Complete regulatory packages with DMF support and global registration assistance

Global Standards

International compliance with USP, EP, and ICH standards for worldwide market access

Partnership Approach

Collaborative relationships with pharmaceutical companies and custom development services