Ambroxol HCl API
Pharmaceutical Premium
Pharmaceutical API

Ambroxol HCl

High-purity pharmaceutical grade Ambroxol HCl API manufactured to meet stringent USP/EP specifications for respiratory and mucolytic treatment formulations. Our pharmaceutical grade API delivers exceptional purity and consistency for critical drug manufacturing applications.

  • USP/EP Grade Quality Standards
  • High Purity ≥99.0% (HPLC)
  • Comprehensive Analytical Documentation
  • Regulatory Compliance Support
  • cGMP Manufacturing Standards
  • Pharmaceutical Grade Packaging
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Technical Specifications

Chemical Formula: C13H18Br2N2O·HCl
CAS Number: 23828-92-4
Molecular Weight: 414.57 g/mol
Purity (HPLC): ≥99.0% (pharmaceutical grade)
Physical State: 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: 25kg, 50kg pharmaceutical drums

Applications

Expectorant Pharmaceutical Formulations
Respiratory Drug Manufacturing
Oral Pharmaceutical Products
API Synthesis & Development
Mucolytic 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 Ambroxol HCl 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: Oral dosage forms

Quality Standards

DRAVYOM's pharmaceutical grade Ambroxol 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 Ambroxol HCl exhibits exceptional chemical properties essential for respiratory 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): 2.8
pKa: 8.8 ± 0.1
UV λmax: 244 nm (water)
Physical Properties
Melting Point: 235-240°C
Bulk Density: 0.5-0.7 g/mL
Crystalline Form: White crystalline powder
Hygroscopicity: Slightly hygroscopic
Pharmaceutical Performance
Bioavailability: 60-70%
Protein Binding: 85%
Half-life: 7-12 hours
Metabolism: Hepatic (demethylation)
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: 5 years (unopened)
Light Sensitivity: Protect from light
Temperature Stability: Stable 15-25°C
pH Stability Range: 4.0-7.0

Performance Characteristics

Detailed performance metrics demonstrate pharmaceutical grade Ambroxol HCl superiority in respiratory applications with exceptional mucolytic activity, precision, and reproducibility across diverse respiratory treatment protocols and research procedures.

Pharmaceutical Performance

Assay: ≥99.0% active pharmaceutical ingredient

Exceptional purity for respiratory formulations
Mucolytic Activity

Efficacy: Superior mucus clearance properties

Enhanced respiratory function support
Dissolution Rate

Solubility: Freely soluble in water

Rapid dissolution characteristics
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

5 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

Ambroxol HCl exhibits mucolytic and expectorant properties through surfactant secretion stimulation and lysosomal enzyme activation, enabling precise respiratory applications with predictable pharmacokinetic pathways and quantitative mucus clearance mechanisms.

Surfactant Stimulation

Enhanced pulmonary surfactant production and secretion

Quantitative respiratory improvement
Lysosomal Activation

Stimulation of lysosomal enzyme activity for mucus breakdown

Essential for mucolytic efficacy
Ciliary Function

Enhancement of ciliary beat frequency and clearance

Enables effective respiratory clearance
Anti-inflammatory Effects

Reduction of inflammatory mediators in respiratory tract

Comprehensive respiratory protection

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 Ambroxol HCl 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 Ambroxol HCl 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 Ambroxol HCl 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 Ambroxol HCl 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: 500+ 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