Dorzolamide Hydrochloride USP/EP
Pharmaceutical USP/EP
Pharmaceutical API

Dorzolamide Hydrochloride USP/EP

High-purity pharmaceutical grade Dorzolamide Hydrochloride manufactured under stringent cGMP conditions. This carbonic anhydrase inhibitor API is essential for glaucoma treatment, particularly in ocular hypertension and intraocular pressure reduction, providing reliable quality and regulatory compliance.

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

Chemical Formula: C10H16N2O4S3·HCl
CAS Number: 120279-96-1
Molecular Weight: 360.90 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: 100g, 500g pharmaceutical containers

Applications

Ophthalmic Drug Manufacturing
Carbonic Anhydrase Inhibitor
Topical Ophthalmic Products
API Synthesis & Development
Glaucoma 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 Dorzolamide Hydrochloride grades tailored for specific pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse ophthalmic 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: Ophthalmic formulations

Quality Standards

DRAVYOM's pharmaceutical grade Dorzolamide Hydrochloride 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 Dorzolamide Hydrochloride exhibits exceptional chemical properties essential for ophthalmic 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): -0.75
pKa: 6.0
Molecular Weight: 360.90 g/mol
Physical Properties
Appearance: White to off-white crystalline powder
Melting Point: 252-254°C
Bulk Density: 0.5-0.7 g/mL
Hygroscopicity: Hygroscopic
Pharmaceutical Performance
Bioavailability: Topical ophthalmic
Protein Binding: 33%
Half-life: 147 days (cornea)
Mechanism: Carbonic anhydrase 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 Dorzolamide Hydrochloride superiority in ophthalmic applications with exceptional carbonic anhydrase inhibition, intraocular pressure reduction, and reproducibility across diverse therapeutic protocols.

IOP Reduction

Potent carbonic anhydrase inhibition

Reduces intraocular pressure
Long Duration

Extended corneal residence time

Sustained therapeutic effect
Stability Profile

Chemical stability: Excellent under storage conditions

Maintains potency for 3 years
Thermal Stability

Melting point: 252-254°C

Stable during pharmaceutical processing
Batch Reproducibility

Variation: ±0.2% between batches

Consistent therapeutic efficacy
High Solubility

Excellent water solubility

Suitable for ophthalmic formulations

Safety Information

Prescription pharmaceutical ingredient requiring professional handling. Well-established safety profile for ophthalmic therapy. Handle with pharmaceutical-grade safety precautions and ensure proper GMP environmental controls. Clinical monitoring for ocular and systemic effects during therapeutic use.

Prescription Only
Professional Use
Monitor ocular effects

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

Dorzolamide Hydrochloride exhibits carbonic anhydrase inhibition properties specifically targeting CA-II enzyme in the ciliary body, reducing aqueous humor production and lowering intraocular pressure.

CA-II Inhibition

Selective inhibition of carbonic anhydrase II enzyme

Reduces aqueous humor formation
IOP Reduction

Decreases intraocular pressure through fluid dynamics

Provides glaucoma therapeutic effect
Selective Action

Preferential binding to ocular carbonic anhydrase

Minimal systemic effects
Topical Efficacy

Direct ocular application for targeted therapy

Enhanced local bioavailability

Regulatory Compliance & Documentation

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

USP Standards

United States Pharmacopeia ophthalmic drug specifications

EP Monograph

European Pharmacopoeia specifications for glaucoma agents

Ophthalmic GMP

Specialized GMP for ophthalmic drug manufacturing

ICH Guidelines

International ophthalmic drug development regulatory compliance

Ophthalmic DMF

Drug Master File for ophthalmic applications

Safety Documentation

Comprehensive ophthalmic safety and pharmacovigilance documentation

Technical Support & Value-Added Services

DRAVYOM's ophthalmic pharmaceutical team provides comprehensive formulation support, stability testing, and regulatory services for Dorzolamide Hydrochloride ophthalmic applications.

Ophthalmic Formulation
  • Ophthalmic formulation optimization
  • Bioavailability enhancement
  • Sterility testing protocols
  • Custom ophthalmic development
Analytical Services
  • API purity and potency analysis
  • Ophthalmic impurity profiling
  • Sterility and endotoxin testing
  • Method validation support
Regulatory Support
  • Ophthalmic regulatory filing
  • DMF preparation and maintenance
  • International compliance guidance
  • Pharmacovigilance support
Supply Solutions
  • Sterile pharmaceutical supply chain
  • Custom packaging solutions
  • Global distribution network
  • Emergency supply arrangements

Environmental Impact & Sustainability

Our Dorzolamide Hydrochloride production emphasizes environmental responsibility through sustainable pharmaceutical manufacturing practices, waste minimization, and comprehensive environmental impact management.

Green Chemistry

Environmentally friendly synthesis and processing methods

Water Conservation

Advanced water treatment and recycling systems

Clean Production

Energy-efficient pharmaceutical manufacturing processes

Waste Reduction

Comprehensive pharmaceutical waste management protocols

ISO 14001

Environmental management system certified production

Sustainable Sourcing

Responsible procurement of pharmaceutical raw materials

Manufacturing Excellence & Quality Control

DRAVYOM's pharmaceutical manufacturing facility employs advanced synthesis technology and continuous monitoring systems to ensure consistent Dorzolamide Hydrochloride quality and ophthalmic therapeutic performance.

Sterile Production

Advanced sterile manufacturing in controlled clean-room environment

Multi-stage purification for ophthalmic grade quality
Quality Testing

Comprehensive testing including assay, sterility, and endotoxins

HPLC verification and ophthalmic analysis
Quality Systems

ISO 9001:2015 quality management with ophthalmic compliance

Continuous improvement and ophthalmic validation
Ophthalmic Packaging

Sterile pharmaceutical-grade containers with moisture protection

Sterility protection and contamination prevention

Market Applications & Performance Data

Comprehensive pharmaceutical data demonstrating Dorzolamide Hydrochloride effectiveness in ophthalmic applications with quantified performance metrics and clinical validation data.

Ophthalmic Formulations
Bioavailability: High topical ocular absorption Stability: 2-year shelf life validated Compatibility: Excellent with ophthalmic excipients
Therapeutic Applications
Glaucoma: Proven IOP reduction efficacy Ocular Safety: Well-tolerated ophthalmic profile Efficacy: Sustained therapeutic response
Manufacturing Performance
Yield: 98% pharmaceutical grade recovery Purity: >99.5% ophthalmic specification Consistency: 99.8% batch-to-batch reproducibility

DRAVYOM Competitive Advantages

Ophthalmic Excellence

Superior ophthalmic pharmaceutical grade with proven therapeutic performance and regulatory compliance

Reliable Supply

Guaranteed availability with strategic inventory management and ophthalmic production scheduling

Formulation Expertise

Dedicated ophthalmic pharmaceutical development team with specialized sterile formulation support

Regulatory Compliance

Complete ophthalmic documentation with DMF support and international compliance

Global Standards

International ophthalmic compliance with USP, EP, and ICH guidelines

Partnership Approach

Collaborative relationships with ophthalmic manufacturers and custom development services