Active Pharmaceutical Ingredient

Alpelisib

Also known as: Piqray

CAS: 1217486-61-7 PI3K Inhibitor / Oncology GMP Standard Bulk Supply Available
Alpelisib API Manufacturer India | Mediocon Inc
Alpelisib — Pharmaceutical Grade API

Product Overview

CAS No: 1217486-61-7  |  MF: C₁₉H₂₂F₃N₅O₂S  |  MW: 441.47 g/mol

Alpelisib is a phosphatidylinositol-3-kinase alpha (PI3Kα) inhibitor indicated for the treatment of PIK3CA-mutated, hormone receptor-positive, HER2-negative advanced breast cancer. Mediocon Inc supplies pharmaceutical-grade Alpelisib for licensed oncology API manufacturers.

Key Features

  • Selective PI3Kα inhibitor
  • GMP compliant manufacturing
  • Used in breast cancer targeted therapy
  • Effective against PIK3CA mutations

Applications

  • HR+/HER2- advanced breast cancer
  • Combination fulvestrant therapy
  • PIK3CA mutation-positive cancer
  • Targeted 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 NameAlpelisib
Also Known AsPiqray
CAS Number1217486-61-7
Molecular FormulaC₁₉H₂₂F₃N₅O₂S
Molecular Weight441.47 g/mol
CategoryPI3K Inhibitor / Oncology Agent
AppearanceWhite to Off-white Powder
GradeIn-house GMP Standard

Analytical Specifications

ParameterSpecification
Assay98.0% – 102.0%
Loss on DryingNMT 1.0%
Melting PointN/A
Heavy MetalsNMT 10 ppm
pHN/A
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Packing1 kg foil pouches / as per requirement
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