Famotidine API
Pharmaceutical Premium
Pharmaceutical API

Famotidine

High-purity pharmaceutical grade Famotidine API manufactured to meet stringent USP/EP specifications for H2 receptor antagonist and acid reduction 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: C8H15N7O2S3
CAS Number: 76824-35-6
Molecular Weight: 337.45 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 (15-25°C)
Packaging Options: 1kg, 5kg pharmaceutical containers

Applications

Antacid Drug Manufacturing
Gastric Acid Reduction Formulations
H2 Receptor Antagonist Products
API Synthesis & Development
Gastroenterology 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 Famotidine grades tailored for specific pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse gastric acid reduction and H2 receptor antagonist 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: Antacid formulations

Quality Standards

DRAVYOM's pharmaceutical grade Famotidine 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
Ultra-Low Impurities
Batch-to-Batch Consistency
Traceable Certificate of Analysis
Temperature-Controlled Logistics

Advanced Chemical Properties & Performance

Pharmaceutical grade Famotidine exhibits exceptional chemical properties essential for antacid therapy applications. Its ultra-pure composition and precise molecular structure ensure reliable performance in demanding pharmaceutical formulations and research applications.

Analytical Properties
Solubility (Water): Slightly soluble
LogP (octanol/water): -0.64
pKa: 7.1
Molecular Weight: 337.43 g/mol
Physical Properties
Appearance: White to pale yellow crystalline powder
Melting Point: 163-164°C
Bulk Density: 0.5-0.7 g/mL
Hygroscopicity: Slightly hygroscopic
Pharmaceutical Performance
Bioavailability: 40-45% (oral)
Protein Binding: 15-20%
Half-life: 2.5-3.5 hours
Mechanism: H2 receptor antagonist
Purity Specifications
Assay (HPLC): ≥99.0%
Related Substances: ≤0.5% total
Water Content: ≤1.0% (Karl Fischer)
Residue on Ignition: ≤0.2%
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 Famotidine superiority in antacid applications with exceptional H2 receptor antagonism, gastric acid suppression, and reproducibility across diverse therapeutic protocols.

H2 Receptor Antagonism

High affinity for H2 receptors

Effective acid suppression
Gastric Protection

Potent gastric acid reduction

Ulcer healing promotion
Stability Profile

Chemical stability: Excellent under storage conditions

Maintains potency for 3 years
Thermal Stability

Melting point: 163-164°C

Stable during pharmaceutical processing
Batch Reproducibility

Variation: ±0.1% between batches

Consistent therapeutic efficacy
Dosing Flexibility

Multiple dosing options available

Twice daily to once daily

Safety Information

Pharmaceutical ingredient requiring professional handling protocols. Well-established safety profile for antacid therapy applications. Handle with appropriate pharmaceutical-grade safety precautions and ensure proper GMP environmental controls. Clinical monitoring for drug interactions and renal function during therapeutic use.

Pharmaceutical Grade
Professional Use
Monitor renal 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
Protect from light
GMP handling required

Chemical Mechanisms & Reaction Pathways

Famotidine exhibits H2 receptor antagonist properties through selective histamine H2 receptor binding, reducing gastric acid secretion and providing effective treatment for gastroesophageal reflux disease, peptic ulcers, and hyperacidity conditions.

H2 Receptor Antagonism

Selective histamine H2 receptor competitive inhibition

Blocks gastric acid secretion
Gastric Protection

Reduces gastric acid production and pepsin activity

Promotes ulcer healing
Long-Acting Profile

Extended duration of action up to 12 hours

Twice-daily dosing convenience
Potent Activity

High potency H2 receptor antagonist

Effective at low doses

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures gastric pharmaceutical manufacturing access with complete documentation packages supporting international standards and H2 receptor antagonist development.

USP Standards

United States Pharmacopeia gastric drug specifications

EP Monograph

European Pharmacopoeia specifications for H2 receptor antagonists

Gastric GMP

Specialized GMP for gastric drug manufacturing

ICH Guidelines

International gastric drug development regulatory compliance

Gastric DMF

Drug Master File for gastric applications

Safety Documentation

Comprehensive gastric safety and pharmacovigilance documentation

Technical Support & Value-Added Services

DRAVYOM's gastric pharmaceutical team provides comprehensive formulation support, stability testing, and regulatory services for Famotidine H2 receptor antagonist applications.

Gastric Formulation
  • H2 receptor antagonist formulation optimization
  • Tablet and capsule development
  • Bioavailability enhancement
  • Custom gastric development
Analytical Services
  • API purity and potency analysis
  • Gastric impurity profiling
  • Stability testing protocols
  • Method validation support
Regulatory Support
  • Gastric regulatory filing
  • DMF preparation and maintenance
  • International compliance guidance
  • Gastric pharmacovigilance
Supply Solutions
  • Gastric pharmaceutical supply chain
  • Custom packaging solutions
  • Global distribution network
  • Emergency gastric supply

Environmental Impact & Sustainability

Our Famotidine 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 Famotidine quality and gastric therapeutic performance.

Pharmaceutical GMP

Advanced manufacturing in controlled clean-room environment

Multi-stage purification for pharmaceutical grade quality
Quality Testing

Comprehensive testing including assay, impurities, and stability

HPLC verification and gastric analysis
Quality Systems

ISO 9001:2015 quality management with pharmaceutical compliance

Continuous improvement and pharmaceutical validation
Pharmaceutical Packaging

Pharmaceutical-grade containers with moisture protection

Stability protection and contamination prevention

Market Applications & Performance Data

Comprehensive gastric data demonstrating Famotidine effectiveness in acid-related disorders with quantified performance metrics and clinical validation data.

Gastric Formulations
Bioavailability: 40-50% oral bioavailability Stability: 3-year shelf life validated Compatibility: Excellent with tablet excipients
Therapeutic Applications
GERD: Proven gastroesophageal reflux disease relief Ulcers: Effective peptic ulcer treatment Safety: Well-tolerated H2 receptor antagonist
Manufacturing Performance
Yield: 95% pharmaceutical grade recovery Purity: >99.5% pharmaceutical specification Consistency: 99.8% batch-to-batch reproducibility

DRAVYOM Competitive Advantages

Gastric Excellence

Superior pharmaceutical grade with proven H2 receptor antagonist activity and regulatory compliance

Reliable Supply

Guaranteed gastric supply with strategic inventory management and specialized production scheduling

Gastric Expertise

Dedicated gastric pharmaceutical development team with specialized H2 antagonist formulation support

Regulatory Compliance

Complete gastric documentation with DMF support and international compliance

Global Standards

International pharmaceutical compliance with USP, EP, and ICH guidelines

Partnership Approach

Collaborative gastric relationships with specialized development services