Active Pharmaceutical Ingredient

Crizotinib

Also known as: Xalkori

CAS: 877399-52-5 Oncology / ALK Inhibitor USP / BP / IP / EP Bulk Supply Available
Crizotinib API Manufacturer India | Mediocon Inc
Crizotinib — Pharmaceutical Grade API

Product Overview

CAS No: 877399-52-5  |  MF: C₂₁H₂₅ClFN₅O  |  MW: 450.91 g/mol

Crizotinib is a small-molecule tyrosine kinase inhibitor targeting ALK (anaplastic lymphoma kinase), ROS1, and MET receptors. It is primarily used in the treatment of ALK-positive or ROS1-positive non-small cell lung cancer (NSCLC). Mediocon Inc supplies pharmaceutical-grade Crizotinib meeting USP, BP, EP, and IP standards for bulk pharma manufacturing.

Key Features

  • Analgesic, antipyretic & anti-inflammatory
  • USP/BP/IP compliant quality
  • Widely used in cardiovascular therapy
  • Suitable for tablet and effervescent formulations

Applications

  • Non-small cell lung cancer (NSCLC)
  • ALK-positive & ROS1-positive tumors
  • MET amplification or exon 14-mutated NSCLC
  • Clinical research oncology formulations

Why Choose Mediocon

  • ISO 9001:2015 & GMP certified manufacturing
  • Consistent batch-to-batch quality with full CoA
  • Export-ready documentation: COO, MSDS, DMF
  • Flexible MOQ for both R&D and commercial scale
  • Dedicated QA support for regulatory filings

Product Specifications

Product NameCrizotinib
Also Known AsXalkori
CAS Number877399-52-5
Molecular FormulaC₂₁H₂₅ClFN₅O
Molecular Weight450.91 g/mol
CategoryALK/ROS1/MET Tyrosine Kinase Inhibitor / Antineoplastic
AppearanceWhite to Off-White Crystalline Powder
GradeUSP / BP / IP / EP

Analytical Specifications

ParameterSpecification
Assay99.0% Min.
Loss on DryingNMT 0.5%
Melting PointN/A (amorphous)
Heavy MetalsNMT 20 ppm
pHN/A
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Packing25 kg HDPE drums / as per requirement
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