Piqray Description

PIQRAY 50 mg tablet: Light pink, unscored, round and curved with bevelled edges, imprinted with "L7" on one side and "NVR" on the other side.
PIQRAY 150 mg tablet: Pale red, unscored, ovaloid and curved with bevelled edges, imprinted with "UL7" on one side and "NVR" on the other side.
PIQRAY 200 mg tablet: Light red, unscored, ovaloid and curved with bevelled edges, imprinted with "YL7" on one side and "NVR" on the other side.
Each tablet contains 50 mg, 150 mg or 200 mg of alpelisib.
Chemical name (IUPAC): (2S)-N¹-{4-Methyl-5-[2-(1,1,1-triflu ro-2-methylpropan-2-yl)pyridin-4-yl]-1,3-thiazol-2-yl}pyrrolidine-1,2-dicarboxamide.
Molecular formula: C₁₉H₂₂F₃N₅O₂S.
Relative molecular mass: 441.47.
Alpelisib is a white to almost white powder at room temperature. It is sparingly soluble in methanol, acetone, and absolute ethanol; it is insoluble/practically insoluble in water, and demonstrates pH-dependent aqueous solubility. Alpelisib is most soluble at pH 1 and has two experimentally determined dissociation constants with pKa values of 3.3 and 9.4. The pH of a 1.0% (m/v) solution of alpelisib in water/ethanol (50:50 v/v) is approximately 6.2. In an n-octanol/pH 6.8 buffer system, alpelisib has a log D of 2.8. Alpelisib is optically active.
Chemical Abstracts Service (CAS) number: 1217486-61-7.
Excipients/Inactive Ingredients: microcrystalline cellulose, mannitol, sodium starch glycollate, hypromellose, magnesium stearate (vegetable source), macrogol, iron oxide red CI77491, iron oxide black CI77499, titanium dioxide (E171), and purified talc.