Pirtobrutinib API
Pharmaceutical Oncology
Oncology API

Pirtobrutinib

High-purity pharmaceutical grade Pirtobrutinib API manufactured to meet stringent USP/EP specifications for targeted cancer therapy formulations. Our pharmaceutical grade API delivers exceptional purity and consistency for critical oncology 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: C23H20ClF2N5O2
CAS Number: 2101244-42-2
EINECS Number: Not applicable
Purity (HPLC): ≥99.0% (USP/EP Grade)
Physical State: White to off-white crystalline powder
Molecular Weight: 487.89 g/mol
Melting Point: 180-185°C
pH (1% solution): 6.0-8.0
Loss on Drying: ≤0.5%
Residue on Ignition: ≤0.1%
Heavy Metals: ≤10 ppm
Solubility: Practically insoluble in water
Storage Conditions: Store at 2-8°C, protect from light
Shelf Life: 3 years from manufacture date
Packaging Options: 1g, 5g, 25g vials

Applications

B-cell Malignancies
Chronic Lymphocytic Leukemia
Oral Tablet Formulations
BTK Inhibitor
Tablet Preparations
Non-Covalent BTK Inhibition
Targeted Hematology Therapy
Mantle Cell Lymphoma
Oncology Research
Clinical Trials
Cancer Drug Development
Regulatory Studies

Industry-Specific Grades

DRAVYOM offers specialized Pirtobrutinib grades tailored for specific oncology applications, ensuring optimal BTK inhibition efficacy and regulatory compliance across diverse cancer treatment formulations.

USP Grade (United States Pharmacopoeia)
Purity: ≥99.0% Water Content: ≤0.5% Heavy Metals: ≤10 ppm Application: FDA approved formulations
EP Grade (European Pharmacopoeia)
Purity: ≥99.0% Related Substances: ≤1.0% Residual Solvents: EP limits Application: European market compliance
Research Grade
Purity: ≥98.0% Activity: Verified Stability: Enhanced Application: Hematology research
Oral Formulation Grade
Purity: ≥99.5% Particle Size: Controlled Bioavailability: Optimized Application: Oral dosage forms

Quality Standards

DRAVYOM's Pirtobrutinib is manufactured under stringent cGMP protocols, meeting international oncology drug standards including USP, EP, and FDA guidelines for targeted hematology therapy applications.

cGMP Manufacturing Standards
USP/EP Grade Specifications
≥99.0% HPLC Purity
Advanced Analytical Testing
BTK Inhibition Verified
Batch-to-Batch Consistency
Comprehensive COA Documentation
Cold Chain Storage & Shipping

Advanced Chemical Properties & Performance

Pharmaceutical Grade Pirtobrutinib exhibits exceptional chemical properties essential for oncology applications. Its potent BTK inhibitor structure and superior stability characteristics ensure reliable performance in demanding targeted cancer therapy formulations.

Molecular Properties
Molecular Weight: 487.54 g/mol
Molecular Formula: C26H25N7O3
LogP (Octanol/Water): 3.2
pKa: 6.8
Physical Properties
Melting Point: >250°C
Appearance: White to off-white crystalline powder
Solubility (Water): Slightly soluble
Bulk Density: 0.40-0.50 g/cm³
Pharmaceutical Properties
Bioavailability: ~90%
Protein Binding: 96%
Half-life: 20 hours
Mechanism: Non-covalent BTK inhibition
Quality Specifications
Purity (HPLC): ≥99.0%
Water Content: ≤0.5%
Related Substances: ≤1.0%
Heavy Metals: ≤10 ppm
Stability Properties
Shelf Life: 3 years (unopened)
Storage Temperature: 15-25°C
Light Sensitivity: Store in light-resistant containers
Moisture Sensitivity: Store in dry conditions

Performance Characteristics

Detailed performance metrics demonstrate Pirtobrutinib superiority in oncology applications with exceptional BTK inhibition, B-cell malignancy activity, and therapeutic efficacy across diverse hematological cancer treatment protocols.

BTK Inhibition

Non-covalent Bruton tyrosine kinase inhibition

Overcoming resistance mutations
B-Cell Activity

Potent activity against B-cell malignancies

Enhanced tumor suppression
CLL/MCL Efficacy

Superior activity in chronic lymphocytic leukemia

Next-generation therapy
Extended Half-life

20-hour elimination half-life

Once-daily dosing convenience
Clinical Performance

FDA-approved for relapsed/refractory B-cell cancers

Proven hematological efficacy
Oral Bioavailability

High oral absorption and tolerability

Patient-friendly administration

Safety Information

Potent targeted therapy pharmaceutical active ingredient requiring careful handling protocols. Handle in controlled environments with appropriate ventilation systems. Use proper personal protective equipment and follow established safety protocols for oncology compounds.

Cytotoxic Agent
Controlled Handling Required
Specialized PPE Required

Storage & Handling

Store in tightly closed, light-resistant containers in a cool, dry place away from direct sunlight. Maintain controlled room temperature storage in secure areas with appropriate containment systems and access controls for oncology compounds.

Controlled room temperature (15-25°C)
Protect from light
Light-resistant containers
Secure storage required

Chemical Mechanisms & Reaction Pathways

Pirtobrutinib functions as a highly selective, non-covalent BTK inhibitor with potent activity against B-cell malignancies, providing effective treatment for hematologic cancers through reversible inhibition of Bruton's tyrosine kinase signaling pathways.

BTK Inhibition

Selective non-covalent Bruton's tyrosine kinase inhibition

Reversible kinase binding mechanism
B-cell Signaling

Disruption of B-cell receptor signaling pathways

Inhibits malignant B-cell proliferation
Resistance Profile

Activity against BTK resistance mutations

Overcomes C481S mutation resistance
Selectivity Profile

High selectivity for BTK over other kinases

Reduced off-target effects

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures global pharmaceutical acceptance with complete documentation packages supporting international drug development and manufacturing requirements.

USP Specifications

United States Pharmacopeia pharmaceutical grade compliance

EP Standards

European Pharmacopoeia specifications and testing protocols

ICH Guidelines

International harmonized pharmaceutical development standards

Global Regulatory

Multi-regional pharmaceutical registration support

DMF Support

Drug Master File preparation and regulatory submission

GMP Compliance

Good Manufacturing Practice certified production

Technical Support & Value-Added Services

DRAVYOM's pharmaceutical development team provides comprehensive formulation support, analytical method development, and regulatory assistance to optimize Pirtobrutinib performance in pharmaceutical applications.

Formulation Development
  • Oral dosage form optimization
  • Bioavailability enhancement
  • Stability improvement strategies
  • Food effect mitigation
Analytical Services
  • Method validation and transfer
  • Impurity profiling and identification
  • Stability testing programs
  • BTK inhibition assays
Regulatory Support
  • Regulatory strategy development
  • Documentation preparation
  • Regulatory submission support
  • Global compliance guidance
Supply Solutions
  • Reliable supply chain management
  • Controlled storage packaging
  • Emergency supply arrangements
  • Global distribution network

Environmental Impact & Sustainability

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

Green Chemistry

Environmentally conscious synthesis with minimal waste

Water Management

Advanced wastewater treatment and recycling systems

Energy Efficiency

Optimized manufacturing processes with reduced energy consumption

Waste Reduction

Comprehensive waste minimization and disposal protocols

ISO 14001

Environmental management system certified production

Carbon Footprint

Reduced environmental impact through sustainable practices

Manufacturing Excellence & Quality Control

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

GMP Production

Good Manufacturing Practice certified facility with controlled environments

Pharmaceutical-grade production standards
Quality Testing

Comprehensive analytical testing including potency and purity

HPLC, LC-MS, and BTK assays
Quality Systems

ISO 9001:2015 quality management with pharmaceutical compliance

Continuous improvement and validation protocols
Packaging Control

Controlled atmosphere packaging with moisture protection

Stability maintenance and protection systems

Market Applications & Performance Data

Comprehensive pharmaceutical data demonstrating Pirtobrutinib effectiveness across diverse therapeutic applications with quantified performance metrics and clinical validation.

Pharmaceutical Manufacturing
Bioavailability: Oral administration optimized Half-life: Once-daily dosing profile Purity: >99.5% pharmaceutical grade
Drug Development
Formulation Support: BTK inhibitor products Regulatory Success: FDA breakthrough therapy Innovation: Non-covalent BTK inhibition
Clinical Applications
Efficacy: Non-covalent BTK inhibition Safety: Improved tolerability profile Specialization: B-cell malignancies

DRAVYOM Competitive Advantages

Pharmaceutical Excellence

Consistently exceeds USP/EP specifications with pharmaceutical-grade quality and performance

Reliable Supply

Guaranteed availability with strategic inventory management and pharmaceutical-grade production

Development Expertise

Dedicated pharmaceutical team provides formulation development and regulatory support

Quality Assurance

Comprehensive documentation with pharmaceutical-grade certificates and regulatory compliance

Global Standards

International compliance with USP, EP, and ICH guidelines for worldwide acceptance

Partnership Approach

Collaborative relationships with pharmaceutical companies and custom development services