Active Pharmaceutical Ingredient

Ibrutinib

Also known as: Imbruvica

CAS: 936563-96-1 BTK Inhibitor / Antineoplastic IP / BP / EP / USP Bulk Supply Available
Ibrutinib API Manufacturer India | Mediocon Inc
Ibrutinib — Pharmaceutical Grade API

Product Overview

CAS No: 936563-96-1  |  MF: C₂₅H₂₄N₆O₂  |  MW: 440.50 g/mol

Ibrutinib is a first-in-class Bruton's tyrosine kinase (BTK) inhibitor used in the treatment of B-cell malignancies including mantle cell lymphoma, CLL, and Waldenström's macroglobulinemia. Mediocon Inc supplies high-purity Ibrutinib API meeting IP/BP/EP/USP standards.

Key Features

  • First-in-class BTK inhibitor
  • IP/BP/EP/USP compliant quality
  • High chemical purity >99%
  • Suitable for oncology formulations

Applications

  • Chronic lymphocytic leukemia (CLL)
  • Mantle cell lymphoma
  • Waldenström's macroglobulinemia
  • Small lymphocytic lymphoma

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 NameIbrutinib
Also Known AsImbruvica
CAS Number936563-96-1
Molecular FormulaC₂₅H₂₄N₆O₂
Molecular Weight440.50 g/mol
CategoryBTK Inhibitor / Antineoplastic
AppearanceWhite to Off-white Crystalline Powder
GradeIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
Assay98.0% – 102.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
pHN/A
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Packing25 kg HDPE drums / as per requirement
💬
Mediocon AI
Hello 👋 How can I help you today?