Bilastine API
Pharmaceutical Premium
Pharmaceutical API

Bilastine

High-purity pharmaceutical grade Bilastine 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
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Technical Specifications

Chemical Formula: C28H37N3O3
CAS Number: 202189-78-4
Molecular Weight: 463.61 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: 5kg, 25kg pharmaceutical containers

Applications

Antihistamine Drug Manufacturing
Allergy Treatment Formulations
Oral Pharmaceutical Products
API Synthesis & Development
H1 Antihistamine 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 Bilastine grades tailored for specific pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse antihistamine 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: Antihistamine formulations

Quality Standards

DRAVYOM's pharmaceutical grade Bilastine 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 Bilastine exhibits exceptional chemical properties essential for antihistamine applications. Its ultra-pure composition and precise molecular structure ensure reliable performance in demanding pharmaceutical formulations and research applications.

Analytical Properties
Solubility (Water): Sparingly soluble
LogP (octanol/water): 2.5
pKa: 2.0, 9.7
UV λmax: 237, 289 nm
Physical Properties
Melting Point: 204-208°C
Bulk Density: 0.4-0.6 g/mL
Crystalline Form: White to off-white crystalline powder
Hygroscopicity: Non-hygroscopic
Pharmaceutical Performance
Bioavailability: 61%
Protein Binding: 84-90%
Half-life: 14.5 hours
Elimination: Renal and fecal
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: 3 years (unopened)
Light Sensitivity: Protect from light
Temperature Stability: Stable 15-30°C
Container Compatibility: HDPE, glass containers

Performance Characteristics

Detailed performance metrics demonstrate pharmaceutical grade Bilastine superiority in antihistamine applications with exceptional H1 receptor selectivity, stability, and reproducibility across diverse pharmaceutical formulations and therapeutic protocols.

H1 Receptor Selectivity

IC50: 1.2 nM for H1 receptors

Highly selective antihistamine action
Tablet Stability

Stable in solid dosage forms for 36 months

Excellent pharmaceutical stability
Bioavailability

61% oral bioavailability achieved

Good absorption characteristics
Temperature Stability

Stable under ambient conditions

Consistent performance 15-30°C
Batch Reproducibility

Variation: ±0.5% between batches

Exceptional lot-to-lot consistency
Shelf Stability

3 years under proper storage conditions

Extended pharmaceutical grade integrity

Safety Information

Handle with standard pharmaceutical safety precautions. Use appropriate personal protective equipment including safety goggles, gloves, and protective clothing. Avoid inhalation of powder and ensure adequate ventilation in work areas. Follow established pharmaceutical handling protocols.

Caution
Avoid Inhalation
Wear Gloves

Storage & Handling

Store in original containers in a cool, dry place protected from light and moisture. Keep containers tightly closed and maintain pharmaceutical storage conditions. Use appropriate handling equipment and ensure controlled environment.

Store at 15-30°C
Protect from light
Protect from moisture
Keep containers tightly closed

Chemical Mechanisms & Reaction Pathways

Bilastine exhibits selective H1 histamine receptor antagonist properties through non-sedating antihistamine structure, enabling precise allergic reaction control with predictable mast cell stabilization pathways and quantitative symptom relief mechanisms.

H1 Receptor Blockade

Selective antagonism of peripheral H1 histamine receptors

Quantitative inhibition of allergic response
Non-Sedating Action

Minimal central nervous system penetration

Essential for daytime allergy management
Mast Cell Stabilization

Prevention of histamine release from mast cells

Enables prophylactic allergy control
Rapid Onset

Fast-acting relief with sustained duration

Predictable 24-hour efficacy

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 Bilastine 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 Bilastine 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 Bilastine 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 Bilastine effectiveness across diverse therapeutic applications with quantified performance metrics and clinical study validations.

Pharmaceutical Manufacturing
Purity: >99.5% pharmaceutical grade Bioavailability: Consistent antihistamine levels Stability: 36+ months under controlled conditions
Research Institutions
Clinical Studies: 250+ 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