Progesterone USP/EP
Pharmaceutical USP/EP
Pharmaceutical API

Progesterone USP/EP

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

  • USP/EP Grade Pharmaceutical API
  • cGMP Manufacturing Standards
  • ≥99.0% Purity (HPLC)
  • Comprehensive COA Documentation
  • Steroid Hormone for HRT
  • Regulatory Compliance Ready
Request Quote Technical Support

Technical Specifications

Chemical Formula: C21H30O2
CAS Number: 57-83-0
EINECS Number: 200-350-6
Purity (HPLC): ≥99.0% (USP/EP Grade)
Physical State: White to off-white crystalline powder
Molecular Weight: 314.46 g/mol
Melting Point: 121-123°C
Optical Rotation: +172° to +182°
Loss on Drying: ≤0.5%
Residue on Ignition: ≤0.1%
Heavy Metals: ≤10 ppm
Solubility: Practically insoluble 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

Hormone Replacement Therapy
Reproductive Health
Oral Capsule Formulations
Tablet Preparations
Injectable Preparations
Menopause Treatment
Steroid Hormone Activity
Contraceptive Formulations
Hormonal Research
Clinical Trials
Endocrine Studies
Pharmaceutical Research

Industry-Specific Grades

DRAVYOM offers specialized Progesterone grades tailored for specific hormone therapy applications, ensuring optimal steroid hormone activity and regulatory compliance across diverse pharmaceutical formulations.

USP Grade (United States Pharmacopoeia)
Purity: ≥99.0% Water Content: ≤0.5% Heavy Metals: ≤10 ppm Application: FDA approved formulations
EP Grade (European Pharmacopoeia)
Purity: ≥99.0% Related Substances: ≤1.0% Optical Rotation: +172° to +182° Application: European market compliance
Injection Grade
Sterility: Assured Endotoxins: <0.25 EU/mg Particulates: Controlled Application: Parenteral preparations
HRT Grade
Enhanced Purity: >99.5% Bioavailability: Optimized Hormonal Activity: Verified Application: Hormone replacement therapy

Quality Standards

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

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

Advanced Chemical Properties & Performance

Pharmaceutical Grade Progesterone exhibits exceptional chemical properties essential for hormone replacement applications. Its potent steroid hormone structure and superior stability characteristics ensure reliable performance in demanding reproductive health and hormone therapy formulations.

Molecular Properties
Molecular Weight: 314.46 g/mol
Molecular Formula: C21H30O2
LogP (Octanol/Water): 3.87
Steroid Classification: C21 pregnane steroid
Physical Properties
Melting Point: 128-132°C
Appearance: White to off-white crystalline powder
Solubility (Water): Practically insoluble
Bulk Density: 0.40-0.50 g/cm³
Pharmaceutical Properties
Bioavailability (Oral): Variable (first-pass metabolism)
Protein Binding: 96-99%
Half-life: 5 minutes (IV), 13-18 hours (oral)
Mechanism: Progesterone receptor agonism
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
Oxidation Sensitivity: Protect from oxidation

Performance Characteristics

Detailed performance metrics demonstrate Progesterone superiority in hormone therapy applications with exceptional reproductive health support, hormone balance restoration, and therapeutic efficacy across diverse women's health treatment protocols.

Reproductive Health

Essential hormone for reproductive function

Menstrual cycle regulation
Receptor Activation

High affinity progesterone receptor binding

Genomic and non-genomic effects
Pregnancy Support

Critical for pregnancy maintenance

Luteal phase support
Dosing Flexibility

Multiple formulation options available

Oral, vaginal, injectable routes
Clinical Efficacy

FDA-approved for assisted reproduction

Proven hormonal benefits
Hormone Balance

Counterbalances estrogen effects

Endometrial protection

Safety Information

Potent steroid hormone 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 hormone compounds.

Hormone Active 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 protect from oxidation to preserve pharmaceutical quality and hormonal potency.

Controlled room temperature (15-25°C)
Protect from light
Light-resistant containers
Protect from oxidation

Chemical Mechanisms & Reaction Pathways

Progesterone exhibits specific steroid hormone receptor interactions and metabolic pathways essential for pharmaceutical applications. Its molecular structure enables precise receptor binding and predictable pharmacological responses in hormone therapy formulations.

Receptor Binding

High-affinity progesterone receptor (PR) binding for genomic effects

Nuclear receptor-mediated gene transcription
Metabolic Pathways

Hepatic metabolism via 20α-hydroxylation and conjugation

Predictable clearance mechanisms
Tissue Selectivity

Specific tissue distribution and receptor expression

Targeted therapeutic action
Hormone Interactions

Estrogen-progesterone receptor crosstalk mechanisms

Balanced hormonal therapeutic effects

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