Active Pharmaceutical Ingredient

Palbociclib

Also known as: Ibrance

CAS: 571190-30-2 CDK4/6 Inhibitor IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Palbociclib API — Mediocon Inc
Palbociclib — Pharmaceutical Grade API

Product Overview

CAS No: 571190-30-2  |  MF: C₂₄H₂₉N₇O₂  |  MW: 447.54 g/mol

Palbociclib is a pharmaceutical-grade active ingredient classified as a CDK4/6 Inhibitor and Antineoplastic Agent. Mediocon Inc supplies high-purity Palbociclib API conforming to IP / BP / EP / USP specifications, manufactured in our GMP-certified facility in Aurangabad, Maharashtra, India.

Palbociclib selectively inhibits cyclin-dependent kinases 4 and 6, blocking cancer cell cycle progression from G1 to S phase. It is primarily used in combination with hormone therapy for the treatment of HR-positive, HER2-negative advanced breast cancer.

Key Features

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

Applications

  • HR+/HER2- breast cancer
  • Metastatic breast cancer (combination therapy)
  • CDK4/6-driven tumors research
  • Oncology formulation development

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 NamePalbociclib
Also Known AsIbrance
CAS Number571190-30-2
Molecular FormulaC₂₄H₂₉N₇O₂
Molecular Weight447.54 g/mol
CategoryCDK4/6 Inhibitor — Antineoplastic Agent
AppearanceOff-white to yellow powder
SolubilitySlightly soluble in water; soluble in organic solvents
GradeIP / BP / EP / USP

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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