Loratadine API
Pharmaceutical Premium
Pharmaceutical API

Loratadine

High-purity pharmaceutical grade Loratadine API manufactured to meet stringent USP/EP specifications for antihistamine and allergy 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
Request Quote Technical Support

Technical Specifications

Chemical Formula: C22H23ClN2O2
CAS Number: 79794-75-5
EINECS Number: 279-157-2
Molecular Weight: 382.88 g/mol
Physical State: White to off-white crystalline powder
Purity (HPLC): ≥99.0% (USP/EP Grade)
Melting Point: 134-136°C
pH (1% solution): 4.0-6.0
Loss on Drying: ≤0.5%
Residue on Ignition: ≤0.1%
Heavy Metals (as Pb): ≤10 ppm
Related Substances: ≤1.0% (total impurities)
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

Oral Tablet Formulations
Syrup Formulations
Antihistamine Therapy
Allergy Treatment
Allergy Research
Hospital Allergy Units
Pharmaceutical Manufacturing
H1 Antihistamine Medications
Immunology Research
Clinical Trials
Regulatory Submissions
Reference Standards

Industry-Specific Grades

DRAVYOM offers specialized Loratadine grades tailored for specific antihistamine pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse allergy medication manufacturing 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) Impurities: Individual ≤0.5% Loss on Drying: ≤0.5% Application: EU regulatory submissions
Antihistamine Research Grade
Purity: ≥99.5% (HPLC) Water Content: ≤0.2% Residue on Ignition: ≤0.05% Application: Allergy research
Reference Standard Grade
Purity: ≥99.8% (HPLC) Certified Analysis: COA included Traceability: NIST traceable Application: Analytical standards

Quality Standards

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

cGMP Certified Manufacturing
USP/EP Grade Specifications
≥99.0% HPLC Purity
Advanced Analytical Testing
Ultra-Low Impurity Levels
Batch-to-Batch Consistency
Comprehensive Certificate of Analysis
Temperature-Controlled Logistics

Advanced Chemical Properties & Performance

Loratadine exhibits exceptional pharmaceutical properties essential for antihistamine applications. Its ultra-pure composition and precise molecular structure ensure reliable performance in demanding pharmaceutical formulations and allergy treatments.

Pharmaceutical Properties
Molecular Weight: 382.88 g/mol
Solubility (Water): Poorly soluble
Partition Coefficient: LogP = 5.2
Bioavailability: ≥80% oral absorption
Physical Properties
Melting Point: 134-136°C
Appearance: White to off-white powder
Crystalline Form: Stable polymorphic form
Bulk Density: 0.35-0.55 g/mL
Formulation Performance
Dissolution Rate: ≥75% in 45 minutes
Tablet Hardness: 4-8 kp compatible
Compressibility: Good with binders
Flow Properties: Fair to good
Purity Specifications
Total Impurities: ≤2.0%
Related Substances: ≤0.5% individual
Heavy Metals: ≤10 ppm
Residual Solvents: ICH Q3C compliant
Stability Properties
Shelf Life: 5 years (unopened)
Light Sensitivity: Protect from light
Temperature Stability: Stable 15-30°C
Humidity Sensitivity: Store below 65% RH

Performance Characteristics

Detailed performance metrics demonstrate Loratadine superiority in pharmaceutical applications with exceptional efficacy, bioavailability, and reproducibility across diverse formulation types and therapeutic protocols.

Therapeutic Performance

Bioavailability: ≥80% oral absorption

Excellent antihistamine efficacy
Dissolution Rate

Release: ≥75% in 45 minutes

Consistent drug release profile
Analytical Performance

Purity: ≥98.0% HPLC

Superior analytical precision
Stability Performance

Shelf life: 5 years under proper storage

Extended pharmaceutical integrity
Batch Reproducibility

Variation: ±2.0% between batches

Exceptional lot-to-lot consistency
Processing Performance

Compressibility: Good with proper binders

Superior manufacturing efficiency

Safety Information

Pharmaceutical grade material requiring appropriate handling procedures. Use standard pharmaceutical safety protocols including proper ventilation, protective equipment, and trained personnel. Follow all applicable regulatory guidelines for pharmaceutical manufacturing and handling.

Pharmaceutical Material
Trained Personnel Required
cGMP Compliance

Storage & Handling

Store in original pharmaceutical packaging in a controlled environment. Maintain temperature and humidity conditions as specified. Protect from light and moisture. Use appropriate material handling equipment and ensure proper documentation for pharmaceutical traceability and regulatory compliance.

Controlled temperature (15-30°C)
Humidity control (≤65% RH)
Protect from light
Complete documentation required

Chemical Mechanisms & Reaction Pathways

Loratadine exhibits selective antihistamine activity through specific H1 receptor antagonism, enabling precise allergy therapeutic applications with predictable pharmacokinetic and pharmacodynamic pathways.

H1 Receptor Binding

Selective antagonism of peripheral H1 histamine receptors

Prevents histamine-mediated allergic responses
Non-Sedating Mechanism

Minimal blood-brain barrier penetration prevents CNS effects

Selective peripheral antihistamine activity
Metabolic Pathway

Hepatic metabolism via CYP3A4 to active desloratadine

Extended therapeutic duration
Binding Selectivity

High selectivity for H1 receptors over other histamine subtypes

Minimized off-target effects

Regulatory Compliance & Documentation

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

USP Specifications

United States Pharmacopeia pharmaceutical grade standards compliance

EP Standards

European Pharmacopoeia specifications for pharmaceutical manufacturing

cGMP Manufacturing

Current Good Manufacturing Practice certified production facility

ICH Guidelines

International Conference on Harmonisation quality standards

DMF Support

Drug Master File documentation for regulatory submissions

Quality Documentation

Complete analytical documentation package with stability data

Technical Support & Value-Added Services

DRAVYOM's pharmaceutical development team provides comprehensive formulation support, analytical method development, and regulatory guidance to optimize Loratadine performance in your specific pharmaceutical applications.

Formulation Development
  • Dosage form optimization support
  • Excipient compatibility studies
  • Bioavailability enhancement guidance
  • Custom formulation protocols
Analytical Services
  • Certificate of Analysis verification
  • Custom impurity profiling
  • Method validation support
  • Stability testing programs
Technical Support
  • Pharmaceutical troubleshooting consultation
  • cGMP compliance guidance
  • Process optimization support
  • Quality system implementation
Supply Solutions
  • Consistent batch scheduling
  • Emergency supply arrangements
  • Custom packaging options
  • Global pharmaceutical distribution

Environmental Impact & Sustainability

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

Waste Minimization

Optimized synthesis with minimal pharmaceutical waste generation

Water Treatment

Advanced pharmaceutical wastewater treatment and recycling systems

Green Chemistry

Environmentally conscious synthesis with emission controls

Safe Disposal

Comprehensive guidance for pharmaceutical waste management

ISO 14001

Environmental management system certified pharmaceutical production

Carbon Footprint

Reduced carbon footprint through process optimization

Manufacturing Excellence & Quality Control

DRAVYOM's state-of-the-art pharmaceutical manufacturing facility employs advanced synthesis technology and continuous monitoring systems to ensure consistent Loratadine quality and performance across all production batches.

Production Process

Advanced synthesis and purification in controlled cGMP environment

Multi-stage crystallization for pharmaceutical grade quality
Quality Testing

Comprehensive analytical testing protocol including related substances analysis

HPLC verification and spectroscopic analysis
Quality Systems

ISO 9001:2015 quality management with pharmaceutical manufacturing accreditation

Continuous improvement and process validation
Packaging Control

Pharmaceutical-grade containers with controlled atmosphere packaging

Moisture protection and contamination prevention

Market Applications & Performance Data

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

Pharmaceutical Manufacturing
Bioavailability: >95% oral absorption Stability: 5+ years shelf life Purity: >99.5% pharmaceutical grade
Clinical Development
Efficacy: Proven antihistamine applications Safety: Well-established safety profile Regulatory: Multiple country approvals
Manufacturing Scale
Capacity: Multi-ton annual production Consistency: <0.1% batch-to-batch variation Compliance: 100% cGMP adherence

DRAVYOM Competitive Advantages

Superior Purity

Consistently exceeds USP/EP specifications with ultra-low impurities and exceptional pharmaceutical 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

Comprehensive certificates with complete analytical data and regulatory documentation

Global Standards

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

Partnership Approach

Collaborative relationships with pharmaceutical companies and custom API development services