Erlotinib Hydrochloride USP/EP
Pharmaceutical USP/EP
Pharmaceutical API

Erlotinib Hydrochloride USP/EP

High-purity pharmaceutical grade Erlotinib Hydrochloride manufactured under stringent cGMP conditions. This EGFR inhibitor API is essential for oncology applications, particularly in non-small cell lung cancer treatment, providing reliable quality and regulatory compliance.

  • USP/EP Grade Pharmaceutical API
  • cGMP Manufacturing Standards
  • ≥98.5% Purity (HPLC)
  • Comprehensive COA Documentation
  • EGFR Inhibitor for Oncology
  • Regulatory Compliance Ready
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Technical Specifications

Chemical Formula: C22H23N3O4·HCl
CAS Number: 183319-69-9
Molecular Weight: 429.90 g/mol
Purity (HPLC): ≥98.5% (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: ≤1.5% total impurities
Storage Conditions: Store in cool, dry place (15-30°C)
Packaging Options: 100g, 500g pharmaceutical containers

Applications

Cancer Therapy Manufacturing
EGFR Inhibitor Formulations
Oral Pharmaceutical Products
API Synthesis & Development
Lung Cancer Treatment
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 Erlotinib Hydrochloride grades tailored for specific pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse oncology drug manufacturing applications.

USP Grade (Pharmaceutical)
Purity: ≥98.5% (HPLC) Water Content: ≤0.5% Heavy Metals: ≤10 ppm Application: Pharmaceutical formulations
EP Grade (European Pharmacopoeia)
Purity: ≥98.5% (pharmaceutical) Related Substances: ≤1.5% Residue on Ignition: ≤0.1% Application: European market compliance
Research Grade
Purity: ≥97.0% (analytical) Water Content: ≤1.0% Particle Size: Controlled Application: R&D, method development
GMP Grade
Purity: ≥99.0% (pharmaceutical) Endotoxins: ≤2.5 EU/mg Microbial Limits: Compliant Application: Oncology formulations

Quality Standards

DRAVYOM's pharmaceutical grade Erlotinib 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
≥98.5% Pharmaceutical Purity
Advanced Analytical Testing
Comprehensive Impurity Control
Batch-to-Batch Consistency
Complete Documentation Package
Temperature-Controlled Logistics

Advanced Chemical Properties & Performance

Pharmaceutical grade Erlotinib Hydrochloride exhibits exceptional chemical properties essential for oncology 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): 3.5
pKa: 5.4
Molecular Weight: 429.90 g/mol
Physical Properties
Appearance: White to off-white crystalline powder
Melting Point: 178-180°C
Bulk Density: 0.5-0.7 g/mL
Hygroscopicity: Hygroscopic
Pharmaceutical Performance
Bioavailability: 76% (oral)
Protein Binding: 95%
Half-life: 24-36 hours
Mechanism: EGFR tyrosine kinase inhibitor
Purity Specifications
Assay (HPLC): ≥98.5%
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 acidic conditions

Performance Characteristics

Detailed performance metrics demonstrate pharmaceutical grade Erlotinib Hydrochloride superiority in oncology applications with exceptional EGFR inhibition, targeted therapy efficacy, and reproducibility across diverse therapeutic protocols.

EGFR Inhibition

Selective EGFR tyrosine kinase inhibition

Blocks tumor growth signals
Targeted Therapy

Selective for EGFR-mutated cancers

Precision oncology treatment
Stability Profile

Chemical stability: Excellent under storage conditions

Maintains potency for 3 years
Thermal Stability

Melting point: 178-180°C

Stable during pharmaceutical processing
Batch Reproducibility

Variation: ±0.1% between batches

Consistent therapeutic efficacy
Oral Bioavailability

76% oral bioavailability

Convenient oral administration

Safety Information

Prescription pharmaceutical ingredient requiring professional handling. Well-established safety profile for oncology therapy. Handle with pharmaceutical-grade safety precautions and ensure proper GMP environmental controls. Clinical monitoring for skin reactions and hepatic function during therapeutic use.

Prescription Only
Professional Use
Monitor skin reactions

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

Erlotinib Hydrochloride exhibits targeted cancer therapy properties through selective EGFR tyrosine kinase inhibition, blocking cancer cell growth signals and inducing apoptosis in EGFR-positive tumors.

EGFR Inhibition

Selective inhibition of epidermal growth factor receptor

Blocks oncogenic signaling pathways
Tyrosine Kinase Blockade

Prevents autophosphorylation of EGFR tyrosine kinase

Disrupts tumor growth signals
Targeted Therapy

Specifically targets EGFR-positive cancer cells

Precision oncology approach
Apoptosis Induction

Induces programmed cell death in cancer cells

Selective cancer cell targeting

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures targeted therapy pharmaceutical manufacturing access with complete documentation packages supporting international standards and EGFR inhibitor development.

USP Standards

United States Pharmacopeia targeted therapy specifications

EP Monograph

European Pharmacopoeia specifications for EGFR inhibitors

Oncology GMP

Specialized GMP for targeted therapy manufacturing

ICH Guidelines

International targeted therapy regulatory compliance

Oncology DMF

Drug Master File for targeted therapy applications

Safety Documentation

Comprehensive targeted therapy safety documentation

Technical Support & Value-Added Services

DRAVYOM's targeted therapy pharmaceutical team provides comprehensive formulation support, stability testing, and regulatory services for Erlotinib Hydrochloride oncology applications.

Targeted Therapy Formulation
  • EGFR inhibitor formulation optimization
  • Bioavailability enhancement
  • Tablet formulation development
  • Custom oncology development
Analytical Services
  • API purity and potency analysis
  • Targeted therapy impurity profiling
  • Stability testing protocols
  • Method validation support
Regulatory Support
  • Targeted therapy regulatory filing
  • DMF preparation and maintenance
  • International compliance guidance
  • Pharmacovigilance support
Supply Solutions
  • Targeted therapy supply chain
  • Custom packaging solutions
  • Global distribution network
  • Emergency supply arrangements

Environmental Impact & Sustainability

Our Erlotinib 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 Erlotinib Hydrochloride quality and targeted therapy performance.

Controlled Production

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 targeted therapy analysis
Quality Systems

ISO 9001:2015 quality management with oncology compliance

Continuous improvement and targeted therapy validation
Pharmaceutical Packaging

Pharmaceutical-grade containers with moisture protection

Stability protection and contamination prevention

Market Applications & Performance Data

Comprehensive targeted therapy data demonstrating Erlotinib Hydrochloride effectiveness in EGFR-positive cancer treatment with quantified performance metrics and clinical validation data.

Targeted Therapy Formulations
Bioavailability: 60% oral bioavailability Stability: 3-year shelf life validated Compatibility: Excellent with tablet excipients
Clinical Applications
NSCLC: Proven efficacy in non-small cell lung cancer EGFR-positive: Selective targeting of mutated tumors Safety: Well-tolerated targeted therapy profile
Manufacturing Performance
Yield: 95% pharmaceutical grade recovery Purity: >99.5% targeted therapy specification Consistency: 99.8% batch-to-batch reproducibility

DRAVYOM Competitive Advantages

Targeted Therapy Excellence

Superior targeted therapy pharmaceutical grade with proven EGFR inhibition and regulatory compliance

Reliable Supply

Guaranteed availability with strategic inventory management and targeted therapy production scheduling

Oncology Expertise

Dedicated targeted therapy development team with specialized formulation support

Regulatory Compliance

Complete targeted therapy documentation with DMF support and international compliance

Global Standards

International oncology compliance with USP, EP, and ICH guidelines

Partnership Approach

Collaborative oncology relationships with specialized development services