Apremilast USP/EP
Pharmaceutical USP/EP
Pharmaceutical API

Apremilast USP/EP

High-purity pharmaceutical grade Apremilast manufactured under stringent cGMP conditions. This phosphodiesterase 4 inhibitor API is essential for treating psoriatic arthritis and autoimmune conditions, providing reliable quality and regulatory compliance for inflammatory disease management.

  • USP/EP Grade Pharmaceutical API
  • cGMP Manufacturing Standards
  • ≥99.0% Purity (HPLC)
  • Comprehensive COA Documentation
  • PDE4 Inhibitor for Psoriatic Arthritis
  • Regulatory Compliance Ready
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Technical Specifications

Chemical Formula: C22H24N2O7S
CAS Number: 608141-41-9
Molecular Weight: 460.50 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 (15-30°C)
Packaging Options: 1kg, 5kg pharmaceutical containers

Applications

Immunosuppressive Drug Manufacturing
Autoimmune Disease Formulations
Oral Pharmaceutical Products
API Synthesis & Development
PDE4 Inhibitor Research
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 Apremilast grades tailored for specific pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse 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: Immunology formulations

Quality Standards

DRAVYOM's pharmaceutical grade Apremilast 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
Comprehensive Impurity Control
Batch-to-Batch Consistency
Complete Documentation Package
Temperature-Controlled Logistics

Advanced Chemical Properties & Performance

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

Analytical Properties
Solubility (Water): Freely soluble
LogP (octanol/water): 1.3
pKa: 9.9 ± 0.1
UV λmax: 234 nm (water)
Physical Properties
Melting Point: 156-159°C
Bulk Density: 0.5-0.7 g/mL
Crystalline Form: White to pale yellow powder
Hygroscopicity: Slightly hygroscopic
Pharmaceutical Performance
Bioavailability: 73%
Protein Binding: 68%
Half-life: 6-9 hours
Metabolism: Hepatic (CYP3A4, hydrolysis)
Purity Specifications
Assay (HPLC): ≥99.0%
Related Substances: ≤1.0% 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: Stable 15-25°C
pH Stability Range: 4.0-8.0

Performance Characteristics

Detailed performance metrics demonstrate pharmaceutical grade Apremilast superiority in inflammatory applications with exceptional PDE4 inhibition efficacy, precision, and reproducibility across diverse autoimmune disease treatment protocols and research procedures.

Pharmaceutical Performance

Assay: ≥99.0% active pharmaceutical ingredient

Exceptional purity for inflammatory formulations
PDE4 Inhibition

Efficacy: Selective phosphodiesterase inhibition

Superior anti-inflammatory selectivity
Dissolution Rate

Bioavailability: 73% oral absorption

Excellent systemic exposure
Thermal Stability

Working range: 15-25°C optimal storage

Maintains potency across temperature range
Batch Consistency

Variation: ±0.2% between manufacturing batches

Exceptional lot-to-lot reproducibility
Extended Stability

3 years shelf life under recommended conditions

Long-term pharmaceutical grade integrity

Safety Information

Pharmaceutical compound requiring standard handling procedures. Use appropriate personal protective equipment and follow good pharmaceutical handling practices. Avoid dust inhalation and skin contact. Handle in well-ventilated areas and ensure proper hygiene measures.

Caution Required
Avoid Contact
Avoid Inhalation

Storage & Handling

Store in original containers in a cool, dry area (15-25°C) away from light and incompatible materials. Keep containers tightly closed and protect from moisture. Use standard pharmaceutical storage protocols and ensure proper material identification and segregation.

Controlled temperature (15-25°C)
Protect from light
Protect from moisture
Original packaging recommended

Chemical Mechanisms & Reaction Pathways

Apremilast exhibits phosphodiesterase 4 (PDE4) inhibition properties through selective enzyme binding, enabling precise immunomodulation applications with predictable pharmacokinetic pathways and quantitative anti-inflammatory mechanisms.

PDE4 Inhibition

Selective inhibition of phosphodiesterase 4 enzyme

Quantitative cAMP elevation and anti-inflammatory effects
Intracellular Signaling

Modulation of cyclic adenosine monophosphate levels

Essential for immunomodulatory activity
Oral Bioavailability

Rapid absorption with predictable systemic exposure

Enables consistent therapeutic effects
Metabolic Pathway

Hepatic metabolism with multiple metabolites

Predictable pharmacokinetic profile

Regulatory Compliance & Documentation

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

USP Specifications

United States Pharmacopeia pharmaceutical standards compliance

EP Standards

European Pharmacopoeia specifications for pharmaceutical analysis

ICH Guidelines

International Conference on Harmonization pharmaceutical compliance

FDA Registration

United States Food and Drug Administration compliance

Method Validation

Supported analytical method validation documentation

SDS Documentation

Multi-language Safety Data Sheets (16 sections, GHS compliant)

Technical Support & Value-Added Services

DRAVYOM's pharmaceutical development team provides comprehensive formulation support, stability testing assistance, and regulatory services to optimize pharmaceutical grade Apremilast performance in your specific therapeutic applications.

Formulation Development
  • Pharmaceutical formulation optimization support
  • Stability testing guidance
  • Bioavailability and bioequivalence validation
  • Custom pharmaceutical procedures
Analytical Services
  • Certificate of Analysis verification
  • Custom purity analysis
  • Impurity profiling and identification
  • Method validation support
Technical Support
  • Pharmaceutical troubleshooting consultation
  • Storage and handling guidance
  • Safety training and protocols
  • Manufacturing best practices
Supply Solutions
  • Consistent batch scheduling
  • Emergency supply arrangements
  • Custom packaging options
  • Global distribution network

Environmental Impact & Sustainability

Our pharmaceutical grade Apremilast production emphasizes environmental responsibility through sustainable manufacturing practices, waste minimization, and comprehensive environmental impact management for pharmaceutical operations.

Waste Minimization

Optimized production with minimal waste generation

Water Treatment

Advanced wastewater treatment and recycling systems

Clean Production

Energy-efficient synthesis with emission controls

Safe Disposal

Comprehensive guidance for pharmaceutical waste management

ISO 14001

Environmental management system certified production

Container Recycling

Pharmaceutical container return and recycling programs

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 grade Apremilast quality and performance across all production batches.

Production Process

Advanced synthesis and purification in controlled cGMP environment

Multi-stage purification for pharmaceutical grade quality
Quality Testing

Comprehensive analytical testing protocol including purity, impurities, and stability

HPLC verification and spectroscopic analysis
Quality Systems

ISO 9001:2015 quality management with pharmaceutical manufacturing accreditation

Continuous improvement and process validation
Packaging Control

Pharmaceutical containers with controlled atmosphere packaging

Stability protection and contamination prevention

Market Applications & Performance Data

Comprehensive pharmaceutical development data demonstrating pharmaceutical grade Apremilast effectiveness across diverse therapeutic applications with quantified performance metrics and clinical study validations.

Pharmaceutical Manufacturing
Purity: >99.5% pharmaceutical grade Bioavailability: Consistent therapeutic levels Stability: 36+ months under controlled conditions
Research Institutions
Clinical Studies: 150+ published research applications Reproducibility: >98% batch-to-batch consistency Innovation: Custom grade development
Generic Manufacturing
Regulatory Success: 100% FDA approval support Cost Efficiency: 25% reduction in manufacturing costs Quality Assurance: Zero batch failures

DRAVYOM Competitive Advantages

Superior Purity

Consistently exceeds pharmaceutical specifications with ultra-low impurities and exceptional therapeutic performance

Reliable Supply

Guaranteed availability with strategic inventory management and pharmaceutical-grade production scheduling

Pharmaceutical Expertise

Dedicated pharmaceutical development team provides formulation and regulatory support

Quality Assurance

Traceable certificates with comprehensive analytical data and regulatory compliance support

Global Standards

International compliance with USP, EP, and ICH specifications for worldwide acceptance

Partnership Approach

Collaborative relationships with pharmaceutical manufacturers and custom development services