Tapentadol HCl
Pharmaceutical Premium
Pharmaceutical API

Tapentadol HCl

High-purity pharmaceutical grade Tapentadol HCl 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: C14H23NO·HCl
CAS Number: 175591-23-8
Molecular Weight: 257.80 g/mol
Physical State: White to off-white crystalline powder
Purity (HPLC): ≥99.0% (USP/EP Grade)
Loss on Drying: ≤0.5%
Residue on Ignition: ≤0.1%
Heavy Metals (as Pb): ≤10 ppm
Related Substances: ≤1.0% (total impurities)
Particle Size: D90 ≤ 100 μm
pH (1% solution): 4.0-6.0
Solubility: Freely soluble in water
Storage Conditions: Store at room temperature, protect from light
Shelf Life: 3 years from date of manufacture
Packaging Options: 25g, 50g, 100g pharmaceutical containers

Applications

Pain Management
Oral Tablet Formulations
Extended Release Capsules
Chronic Pain Treatment
Hospital Formulations
Analgesic Medications
Prescription Pain Relief
Centrally Acting Analgesic
Pain Research
Controlled Release Tablets
Regulatory Submissions
Reference Standards

Industry-Specific Grades

DRAVYOM offers specialized Tapentadol HCl grades tailored for specific pain management pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse analgesic therapeutic applications.

USP Grade (United States Pharmacopeia)
Purity: ≥99.0% (HPLC) Related Substances: ≤1.0% Heavy Metals: ≤10 ppm Application: FDA-compliant formulations
EP Grade (European Pharmacopoeia)
Purity: ≥99.0% (HPLC) Loss on Drying: ≤0.5% pH: 4.0-6.0 (1% solution) Application: EU regulatory submissions
Analgesic Grade
Purity: ≥99.5% (HPLC) Analgesic Activity: Verified Bioavailability: Optimized Application: Pain management medications
Extended Release Grade
Purity: ≥99.8% (HPLC) Particle Size: Controlled Release Profile: Optimized Application: Extended release formulations

Quality Standards

DRAVYOM's Tapentadol HCl is manufactured under stringent quality control protocols, meeting international pharmaceutical standards including USP, EP specifications. Our analgesic-grade production ensures consistent performance and regulatory compliance.

ISO 9001:2015 Certified Manufacturing
USP/EP Grade Specifications
≥99.0% HPLC Purity
Advanced Pain Management Testing
Analgesic Activity Verified
Batch-to-Batch Consistency
Comprehensive COA
Pharmaceutical Grade Packaging

Advanced Chemical Properties & Performance

Pharmaceutical Grade Tapentadol HCl exhibits exceptional chemical properties essential for analgesic applications. Its unique dual mechanism composition and precise specification ensure reliable performance in demanding pharmaceutical formulations and pain management systems.

Chemical Properties
Molecular Formula: C₁₄H₂₃NO·HCl
Molecular Weight: 257.80 g/mol
Melting Point: 88-92°C
LogP (Octanol/Water): 2.87
Physical Properties
Appearance: White to off-white crystalline powder
Solubility: Freely soluble in water
pH (1% solution): 4.0-6.0
Hygroscopicity: Slightly hygroscopic
Pharmaceutical Performance
Bioavailability: 32% (oral)
Half-life: 4-6 hours
Protein Binding: 20%
Mechanism: μ-opioid receptor agonist + NRI
Purity Specifications
Assay (HPLC): ≥ 99.0%
Related Substances: ≤ 0.5%
Heavy Metals: ≤ 20 ppm
Residual Solvents: Within ICH limits
Stability Properties
Shelf Life: 3 years (unopened)
Photostability: Light sensitive (store protected)
Temperature Stability: Stable 15-25°C
Humidity Stability: Store ≤30% RH

Performance Characteristics

Detailed performance metrics demonstrate Pharmaceutical Grade Tapentadol HCl superiority in analgesic applications with exceptional functionality, stability, and reproducibility across diverse pharmaceutical procedures and pain management protocols.

Analgesic Efficacy

Potency: Equivalent to morphine with dual mechanism

Enhanced pain relief with reduced side effects
Onset of Action

Time: 30-60 minutes for therapeutic effect

Rapid pain relief initiation
Bioavailability

Absorption: 32% oral bioavailability

Predictable therapeutic levels
Formulation Stability

Range: Stable in standard formulations

Consistent performance across dosage forms
Batch Uniformity

Variation: ±0.5% between production batches

Exceptional pharmaceutical grade consistency
Long-term Stability

3 years shelf life with maintained potency

Extended pharmaceutical grade integrity

Safety Information

Controlled substance (Schedule II) with potential for abuse and dependence. Handle with strict security protocols and appropriate protective equipment. Requires special storage and handling procedures. Avoid inhalation of powder and ensure proper ventilation during processing.

Controlled Substance
Security Required
Restricted Access

Storage & Handling

Store in original sealed containers in a cool, dry, well-ventilated area with controlled access and security measures. Keep containers tightly closed and protect from light and moisture. Use appropriate pharmaceutical handling procedures with enhanced security protocols for controlled substances.

Cool storage (15-25°C)
Low humidity (≤30% RH)
Protect from light
Secure storage required

Chemical Mechanisms & Reaction Pathways

Pharmaceutical Grade Tapentadol HCl exhibits dual-mechanism analgesic properties through μ-opioid receptor agonism and norepinephrine reuptake inhibition enabling effective pain management with unique pharmacological characteristics.

Opioid Mechanism

μ-opioid receptor binding provides analgesic efficacy

Primary mechanism for moderate to severe pain
Norepinephrine Reuptake

Inhibition of norepinephrine reuptake enhances pain control

Complementary non-opioid analgesic pathway
Receptor Selectivity

Selective binding profile with reduced side effects

Improved tolerability compared to traditional opioids
Metabolic Pathway

Predictable hepatic metabolism with well-characterized kinetics

Enables precise dosing and therapeutic monitoring

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures global pharmaceutical market access with complete controlled substance documentation supporting international standards and API manufacturing validations.

USP Specifications

United States Pharmacopeia API standards compliance

EP Standards

European Pharmacopoeia specifications for pharmaceutical manufacturing

Controlled Substance

Schedule II controlled substance with complete regulatory documentation

International Compliance

Global regulatory compliance including WHO guidelines

DMF Documentation

Drug Master File with comprehensive manufacturing data

cGMP Certified

Current Good Manufacturing Practice with enhanced security protocols

Technical Support & Value-Added Services

DRAVYOM's specialized pharmaceutical team provides comprehensive API support, formulation development assistance, and regulatory services for controlled substance manufacturing with enhanced security protocols.

API Development
  • Controlled release formulation support
  • Stability optimization studies
  • Bioavailability enhancement
  • Analytical method development
Analytical Services
  • Certificate of Analysis with enhanced testing
  • Impurity profiling and identification
  • Polymorphic characterization
  • Stability study support
Regulatory Support
  • Controlled substance documentation
  • Regulatory filing assistance
  • Compliance consultation
  • Audit preparation support
Secure Supply
  • Enhanced security protocols
  • Chain of custody documentation
  • Temperature-controlled shipping
  • Global distribution with tracking

Environmental Impact & Sustainability

Our Pharmaceutical Grade Tapentadol HCl production emphasizes environmental responsibility through green chemistry principles, sustainable synthetic pathways, and comprehensive environmental impact management.

Green Chemistry

Optimized synthetic routes with minimal environmental impact

Solvent Recovery

Advanced solvent recycling and waste minimization

Clean Production

Energy-efficient synthesis with emission controls

Water Treatment

Advanced wastewater treatment and recycling systems

ISO 14001

Environmental management system certified production

Safe Disposal

Controlled substance waste management protocols

Manufacturing Excellence & Quality Control

DRAVYOM's state-of-the-art controlled substance manufacturing facility employs advanced security measures and continuous monitoring systems to ensure consistent Pharmaceutical Grade Tapentadol HCl quality and regulatory compliance.

Secure Production

High-security manufacturing with controlled access and monitoring

DEA-compliant facility with enhanced security protocols
Quality Testing

30-point pharmaceutical testing protocol including polymorphic analysis

HPLC verification and chiral purity assessment
Quality Systems

Enhanced cGMP compliance with controlled substance requirements

Continuous monitoring and validated processes
Secure Packaging

Tamper-evident packaging with chain of custody tracking

Enhanced security and environmental protection

Market Applications & Performance Data

Comprehensive clinical and pharmaceutical data demonstrating Pharmaceutical Grade Tapentadol HCl effectiveness across diverse pain management applications with quantified therapeutic metrics.

Immediate Release
Onset: 30-60 minutes therapeutic effect Bioavailability: 32% oral absorption Duration: 4-6 hours pain relief
Extended Release
Duration: 12-hour therapeutic coverage Compliance: Improved dosing schedule Efficacy: Consistent pain control
Clinical Applications
Chronic Pain: Proven long-term efficacy Acute Pain: Effective post-operative management Neuropathic: Dual mechanism benefits

DRAVYOM Competitive Advantages

Superior Purity

Consistently exceeds pharmacopeial specifications with optimal polymorphic control and impurity profile

Secure Supply

Guaranteed availability with enhanced security protocols and controlled substance compliance

API Expertise

Specialized controlled substance manufacturing with comprehensive regulatory support

Quality Assurance

Enhanced testing protocols with complete documentation and regulatory compliance

Global Standards

International compliance with USP, EP, and controlled substance regulations worldwide

Partnership Approach

Collaborative relationships with pharmaceutical companies and comprehensive development support