Active Pharmaceutical Ingredient

Dasatinib Monohydrate

Also known as: Sprycel

CAS: 863127-77-9 Antineoplastic / Tyrosine Kinase Inhibitor IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Dasatinib Monohydrate API — Mediocon Inc
Dasatinib Monohydrate — Pharmaceutical Grade API

Product Overview

CAS No: 863127-77-9  |  MF: C22H28ClN7O3S·H2O  |  MW: 506.03

Dasatinib Monohydrate is a pharmaceutical-grade active ingredient classified as Antineoplastic / Tyrosine Kinase Inhibitor. Mediocon Inc supplies high-purity Dasatinib Monohydrate API conforming to IP / BP / EP / USP specifications, manufactured in our GMP-certified facility in Aurangabad, Maharashtra, India.

Dasatinib Monohydrate works by tyrosine kinase inhibitor mechanism to provide therapeutic efficacy. It is used as a critical raw material in finished dosage form manufacturing for global pharmaceutical markets.

Key Features

  • High-purity pharmaceutical grade API
  • IP/BP/EP/USP compliant
  • Full CoA and MSDS documentation
  • GMP certified manufacturing

Applications

  • Chronic myeloid leukemia (CML)
  • Acute lymphoblastic leukemia (ALL)
  • Philadelphia chromosome-positive malignancies
  • Hematology research

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 NameDasatinib Monohydrate
CAS Number863127-77-9
Molecular FormulaC22H28ClN7O3S·H2O
Molecular Weight506.03
CategoryAntineoplastic / Tyrosine Kinase Inhibitor
AppearanceWhite to off-white crystalline powder
GradeIP / BP / EP / USP
Batch NoDAS2503021
Mfg DateMAR 2025
Exp DateFEB 2030
Quantity25.00 Kg
Gross Weight26.00 Kg

Analytical Specifications

ParameterSpecification
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Packing25 kg HDPE drums / as per requirement
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