Duloxetine HCl
Pharmaceutical Premium
Pharmaceutical API

Duloxetine HCl

High-purity pharmaceutical grade Duloxetine 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: C18H19NOS·HCl
CAS Number: 136434-34-9
Molecular Weight: 333.88 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

Antidepressant Drug Manufacturing
SNRI Formulations
Oral Pharmaceutical Products
API Synthesis & Development
Depression Treatment 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 Duloxetine HCl grades tailored for specific pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse antidepressant 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: CNS disorder formulations

Quality Standards

DRAVYOM's pharmaceutical grade Duloxetine HCl 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 Duloxetine HCl exhibits exceptional chemical properties essential for CNS 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): 4.6
pKa: 9.7
Molecular Weight: 333.88 g/mol
Physical Properties
Appearance: White to off-white crystalline powder
Melting Point: 164-166°C
Bulk Density: 0.5-0.7 g/mL
Hygroscopicity: Hygroscopic
Pharmaceutical Performance
Bioavailability: 50% (oral)
Protein Binding: 96%
Half-life: 12 hours
Mechanism: Serotonin-norepinephrine reuptake inhibitor
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 Duloxetine HCl superiority in CNS applications with exceptional dual reuptake inhibition, antidepressant efficacy, and reproducibility across diverse therapeutic protocols.

Dual Reuptake Inhibition

Blocks serotonin and norepinephrine reuptake

Enhances neurotransmission
Balanced Profile

Optimal antidepressant efficacy

Treats depression and anxiety
Stability Profile

Chemical stability: Excellent under storage conditions

Maintains potency for 3 years
Thermal Stability

Melting point: 164-166°C

Stable during pharmaceutical processing
Batch Reproducibility

Variation: ±0.2% between batches

Consistent therapeutic efficacy
Moderate Half-life

12-hour half-life for twice-daily dosing

Optimal dosing schedule

Safety Information

Prescription pharmaceutical ingredient requiring professional handling. Well-established safety profile for CNS therapy. Handle with pharmaceutical-grade safety precautions and ensure proper GMP environmental controls. Clinical monitoring for hepatic function and withdrawal symptoms during therapeutic use.

Prescription Only
Professional Use
Monitor liver function

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 (hygroscopic)
Protect from light
GMP handling required

Chemical Mechanisms & Reaction Pathways

Duloxetine HCl exhibits dual-action antidepressant properties through selective serotonin and norepinephrine reuptake inhibition, modulating neurotransmitter balance in the central nervous system for mood regulation.

SNRI Mechanism

Dual inhibition of serotonin and norepinephrine transporters

Increases synaptic neurotransmitter levels
Mood Enhancement

Balances neurotransmitter systems for therapeutic effect

Provides antidepressant and anxiolytic benefits
Pain Modulation

Descending pain pathway inhibition through CNS action

Dual indication for depression and pain
Selective Action

Minimal activity at other neurotransmitter systems

Reduced side effect profile

Regulatory Compliance & Documentation

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

USP Standards

United States Pharmacopeia CNS drug specifications compliance

EP Monograph

European Pharmacopoeia specifications for SNRI agents

CNS GMP

Specialized GMP compliance for CNS drug manufacturing

ICH Guidelines

International CNS drug development regulatory compliance

CNS DMF

Specialized Drug Master File for CNS applications

Safety Documentation

Comprehensive CNS safety and pharmacovigilance documentation

Technical Support & Value-Added Services

DRAVYOM's CNS pharmaceutical team provides comprehensive formulation support, stability testing, and regulatory services for Duloxetine HCl CNS applications.

CNS Formulation
  • CNS formulation optimization
  • Bioavailability enhancement
  • Extended release development
  • Custom CNS development
CNS Analytics
  • CNS API purity analysis
  • Neurotransmitter activity profiling
  • Stability testing services
  • CNS method validation
Regulatory Support
  • CNS regulatory filing
  • Antidepressant DMF preparation
  • International compliance guidance
  • CNS pharmacovigilance
Supply Solutions
  • CNS pharmaceutical supply chain
  • Specialized packaging solutions
  • Global distribution network
  • Emergency CNS supply

Environmental Impact & Sustainability

Our Duloxetine HCl production emphasizes environmental responsibility through sustainable CNS pharmaceutical manufacturing practices, waste minimization, and comprehensive environmental impact management.

Green Chemistry

Environmentally friendly CNS synthesis and processing methods

Water Conservation

Advanced water treatment and recycling systems

Clean Production

Energy-efficient CNS pharmaceutical manufacturing processes

Waste Reduction

Comprehensive CNS pharmaceutical waste management protocols

ISO 14001

Environmental management system certified production

Sustainable Sourcing

Responsible procurement of CNS pharmaceutical raw materials

Manufacturing Excellence & Quality Control

DRAVYOM's CNS pharmaceutical manufacturing facility employs advanced synthesis technology and continuous monitoring systems to ensure consistent Duloxetine HCl quality and therapeutic performance.

CNS GMP

Specialized CNS manufacturing in controlled environment

Multi-stage purification for CNS grade quality
CNS Testing

Comprehensive testing including assay, impurities, and stability

HPLC verification and CNS activity analysis
Quality Systems

ISO 9001:2015 quality management with CNS compliance

Continuous improvement and CNS validation
CNS Packaging

Pharmaceutical-grade containers with moisture protection

Stability protection and contamination prevention

Market Applications & Performance Data

Comprehensive CNS data demonstrating Duloxetine HCl effectiveness in depression and pain management with quantified performance metrics and clinical validation data.

CNS Formulations
Bioavailability: 50% oral bioavailability Stability: 3-year shelf life validated Compatibility: Excellent with CNS excipients
Therapeutic Applications
Depression: Proven antidepressant efficacy Pain Management: Effective for chronic pain Safety: Well-tolerated CNS profile
Manufacturing Performance
Yield: 97% pharmaceutical grade recovery Purity: >99.5% CNS specification Consistency: 99.8% batch-to-batch reproducibility

DRAVYOM Competitive Advantages

CNS Excellence

Superior CNS pharmaceutical grade with proven therapeutic performance and regulatory compliance

Reliable Supply

Guaranteed CNS supply with strategic inventory management and specialized production scheduling

CNS Expertise

Dedicated CNS pharmaceutical development team with specialized formulation support

Regulatory Compliance

Complete CNS documentation with DMF support and international compliance

Global Standards

International CNS compliance with USP, EP, and ICH guidelines

Partnership Approach

Collaborative CNS relationships with specialized development services