Description

Alpelisib (BYL719) is a potent, selective, and orally bioavailable phosphatidylinositol 3-kinase (PI3K) inhibitor, specifically targeting the p110α isoform. This compound is a critical small molecule active pharmaceutical ingredient (API) for targeted cancer therapy development, offering a mechanism to address tumors with PIK3CA mutations. It is essential for pharmaceutical R&D teams, clinical research organizations (CROs), and manufacturers focused on developing and producing innovative oncology treatments, particularly for breast cancer and other solid tumors.

Application

• Primary Active Pharmaceutical Ingredient (API) for the formulation of targeted oncology drugs.
• Key reference standard and impurity marker in analytical method development and quality control for pharmaceutical manufacturing.
• Critical research tool for in vitro and in vivo studies investigating the PI3K/AKT/mTOR signaling pathway in cancer biology.
• Development of combination therapies for hormone receptor-positive (HR+), HER2-negative advanced or metastatic breast cancer with PIK3CA mutations.
• Pre-clinical research into other solid tumors where PI3K pathway dysregulation is a driver.
• Use in biochemical assays for high-throughput screening and drug discovery programs targeting kinase inhibition.

Basic Information

Product Name	Alpelisib (BYL719)
CAS No.	1217486-61-7
Molecular Formula	C19H22F3N5O2S
Molecular Weight	441.47 g/mol
Synonyms	BYL-719; BYL719; Alpelisibum; NVP-BYL719; 2-(6-Amino-8-[(6-fluoro-2-methyl-1H-indol-5-yl)oxy]-1,3-benzothiazol-2-yl)propan-2-ol; PI3K inhibitor BYL719; PI3Kα inhibitor; PIK3CA inhibitor; 5-[2-(2-Amino-1,3-benzothiazol-6-yloxy)-6-fluoro-3-methyl-1H-indol-5-yloxy]-2,2-dimethylpentanenitrile (obsolete)
EINECS	Contact for details

Quality Control

Our Alpelisib is manufactured under strict quality management systems to ensure the highest standards for pharmaceutical research and development. Each batch is subjected to comprehensive analytical testing, including identity confirmation, purity assay, and detailed impurity profiling. A Certificate of Analysis (COA) is provided with every shipment, detailing results against stringent in-house specifications aligned with ICH guidelines. We support development from pre-clinical to commercial scale with consistent quality and full traceability.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled under dry conditions to maintain stability and potency. For long-term storage, consider desiccants and inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥98.0%
Water Content (KF)	≤1.0%
Residue on Ignition	≤0.1%
Heavy Metals	≤20 ppm
Related Substances (HPLC)	Individual impurity: ≤0.5%; Total impurities: ≤2.0%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.