Estradiol USP/EP
Pharmaceutical USP/EP
Pharmaceutical API

Estradiol USP/EP

High-purity pharmaceutical grade Estradiol manufactured under stringent cGMP conditions. This primary estrogen hormone API is essential for hormone replacement therapy, particularly in menopause treatment and reproductive health, providing reliable quality and regulatory compliance.

  • USP/EP Grade Pharmaceutical API
  • cGMP Manufacturing Standards
  • ≥99.0% Purity (HPLC)
  • Comprehensive COA Documentation
  • Primary Estrogen for HRT
  • Regulatory Compliance Ready
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Technical Specifications

Chemical Formula: C18H24O2
CAS Number: 50-28-2
Molecular Weight: 272.38 g/mol
Purity (HPLC): ≥99.0% (pharmaceutical grade)
Physical State: White to off-white crystalline powder
Water Content (Karl Fischer): ≤0.5%
Residue on Ignition: ≤0.1%
Heavy Metals (as Pb): ≤10 ppm
Related Substances: ≤1.0% total impurities
Storage Conditions: Store in cool, dry place (15-25°C)
Packaging Options: 100g, 500g pharmaceutical containers

Applications

Hormone Replacement Therapy
Menopause Treatment Formulations
Estrogen Supplement Products
API Synthesis & Development
Hormonal Research Applications
Pharmaceutical Research
Drug Product Manufacturing
Quality Control Testing
Regulatory Compliance
Clinical Trial Materials
Bioanalytical Method Development
Reference Standard Applications

Industry-Specific Grades

DRAVYOM offers specialized Estradiol grades tailored for specific pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse hormone replacement therapy and estrogen supplement drug manufacturing applications.

USP Grade (Pharmaceutical)
Purity: ≥99.0% (HPLC) Water Content: ≤0.5% Heavy Metals: ≤10 ppm Application: Pharmaceutical formulations
EP Grade (European Pharmacopoeia)
Purity: ≥99.0% (pharmaceutical) Related Substances: ≤1.0% Residue on Ignition: ≤0.1% Application: European market compliance
Research Grade
Purity: ≥98.0% (analytical) Water Content: ≤1.0% Particle Size: Controlled Application: R&D, method development
GMP Grade
Purity: ≥99.5% (pharmaceutical) Endotoxins: ≤2.5 EU/mg Microbial Limits: Compliant Application: Hormone therapy formulations

Quality Standards

DRAVYOM's pharmaceutical grade Estradiol is manufactured under stringent cGMP protocols, meeting international pharmaceutical standards including USP, EP, and ICH guidelines. Our pharmaceutical-grade production ensures consistent quality and regulatory compliance.

cGMP Certified Manufacturing
USP/EP Grade Specifications
≥99.0% Pharmaceutical Purity
Advanced Analytical Testing
Ultra-Low Impurities
Batch-to-Batch Consistency
Traceable Certificate of Analysis
Temperature-Controlled Logistics

Advanced Chemical Properties & Performance

Pharmaceutical grade Estradiol exhibits exceptional chemical properties essential for hormone therapy applications. Its ultra-pure composition and precise molecular structure ensure reliable performance in demanding pharmaceutical formulations and research applications.

Analytical Properties
Solubility (Water): Practically insoluble
LogP (octanol/water): 4.0
pKa: 10.4
Molecular Weight: 272.38 g/mol
Physical Properties
Appearance: White to off-white crystalline powder
Melting Point: 173-179°C
Bulk Density: 0.4-0.6 g/mL
Hygroscopicity: Non-hygroscopic
Pharmaceutical Performance
Bioavailability: 5% (oral), 100% (transdermal)
Protein Binding: 98%
Half-life: 1-2 hours
Mechanism: Estrogen receptor agonist
Purity Specifications
Assay (HPLC): ≥99.0%
Related Substances: ≤0.5% total
Water Content: ≤0.5% (Karl Fischer)
Residue on Ignition: ≤0.1%
Stability Properties
Shelf Life: 3 years (unopened)
Light Sensitivity: Protect from light
Temperature Stability: Store below 25°C
pH Stability: Stable in neutral conditions

Performance Characteristics

Detailed performance metrics demonstrate pharmaceutical grade Estradiol superiority in hormone therapy applications with exceptional estrogen receptor binding, tissue-specific activity, and reproducibility across diverse therapeutic protocols.

Estrogen Activity

Potent estrogen receptor activation

Superior hormonal activity
Cardioprotective

Cardiovascular protective effects

Enhanced vascular function
Stability Profile

Chemical stability: Excellent under storage conditions

Maintains potency for 3 years
Thermal Stability

Melting point: 173-179°C

Stable during pharmaceutical processing
Batch Reproducibility

Variation: ±0.1% between batches

Consistent therapeutic efficacy
Transdermal Compatibility

Excellent transdermal delivery

Optimal skin penetration

Safety Information

Prescription pharmaceutical ingredient requiring professional handling. Well-established safety profile for hormone therapy. Handle with pharmaceutical-grade safety precautions and ensure proper GMP environmental controls. Clinical monitoring for thromboembolic events and breast cancer risk during therapeutic use.

Prescription Only
Professional Use
Monitor for contraindications

Storage & Handling

Store in original containers in a cool, dry, well-ventilated area away from moisture and light. Keep containers tightly closed and maintain pharmaceutical-grade environmental controls. Use appropriate GMP handling techniques for API processing.

Cool storage (15-25°C)
Protect from moisture
Protect from light
GMP handling required

Chemical Mechanisms & Reaction Pathways

Estradiol exhibits estrogenic hormone activity through selective estrogen receptor binding, modulating gene expression and cellular functions for hormone replacement therapy, contraception, and reproductive health management.

Estrogen Receptor Binding

High-affinity binding to estrogen receptors α and β

Activates hormone-responsive genes
Gene Expression

Modulates transcription of estrogen-responsive genes

Regulates cellular differentiation
Reproductive Function

Essential for reproductive system development and function

Maintains reproductive health
Metabolic Effects

Influences bone metabolism and cardiovascular function

Systemic hormone activity

Regulatory Compliance & Documentation

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

USP Standards

United States Pharmacopeia hormone drug specifications

EP Monograph

European Pharmacopoeia specifications for estrogen hormones

Hormone GMP

Specialized GMP for hormone drug manufacturing

ICH Guidelines

International hormone drug development regulatory compliance

Hormone DMF

Drug Master File for hormone applications

Safety Documentation

Comprehensive hormone safety and pharmacovigilance documentation

Technical Support & Value-Added Services

DRAVYOM's hormone pharmaceutical team provides comprehensive formulation support, stability testing, and regulatory services for Estradiol hormone applications.

Hormone Formulation
  • Estrogen formulation optimization
  • Transdermal patch development
  • Bioavailability enhancement
  • Custom hormone development
Analytical Services
  • Hormone purity and potency analysis
  • Estradiol impurity profiling
  • Stability testing protocols
  • Method validation support
Regulatory Support
  • Hormone regulatory filing
  • DMF preparation and maintenance
  • International compliance guidance
  • Hormone pharmacovigilance
Supply Solutions
  • Hormone pharmaceutical supply chain
  • Custom packaging solutions
  • Global distribution network
  • Emergency hormone supply

Environmental Impact & Sustainability

Our Estradiol production emphasizes environmental responsibility through sustainable hormone manufacturing practices, waste minimization, and comprehensive environmental impact management.

Green Chemistry

Environmentally friendly hormone synthesis and processing methods

Water Conservation

Advanced water treatment and recycling systems

Clean Production

Energy-efficient hormone manufacturing processes

Waste Reduction

Comprehensive hormone waste management protocols

ISO 14001

Environmental management system certified production

Sustainable Sourcing

Responsible procurement of hormone raw materials

Manufacturing Excellence & Quality Control

DRAVYOM's hormone manufacturing facility employs advanced synthesis technology and continuous monitoring systems to ensure consistent Estradiol quality and hormone therapeutic performance.

Hormone GMP

Specialized hormone manufacturing in controlled environment

Multi-stage purification for hormone grade quality
Quality Testing

Comprehensive testing including assay, impurities, and stability

HPLC verification and hormone analysis
Quality Systems

ISO 9001:2015 quality management with hormone compliance

Continuous improvement and hormone validation
Hormone Packaging

Pharmaceutical-grade containers with moisture protection

Stability protection and contamination prevention

Market Applications & Performance Data

Comprehensive hormone data demonstrating Estradiol effectiveness in hormone replacement therapy with quantified performance metrics and clinical validation data.

Hormone Formulations
Bioavailability: Variable by route (oral, transdermal, injection) Stability: 3-year shelf life validated Compatibility: Excellent with various delivery systems
Therapeutic Applications
HRT: Proven hormone replacement therapy Contraception: Effective birth control component Safety: Well-characterized hormone profile
Manufacturing Performance
Yield: 95% pharmaceutical grade recovery Purity: >99.5% hormone specification Consistency: 99.8% batch-to-batch reproducibility

DRAVYOM Competitive Advantages

Hormone Excellence

Superior hormone pharmaceutical grade with proven estrogen activity and regulatory compliance

Reliable Supply

Guaranteed hormone supply with strategic inventory management and specialized production scheduling

Hormone Expertise

Dedicated hormone development team with specialized estrogen formulation support

Regulatory Compliance

Complete hormone documentation with DMF support and international compliance

Global Standards

International hormone compliance with USP, EP, and ICH guidelines

Partnership Approach

Collaborative hormone relationships with specialized development services