Ilaprazole sodium

China [CN]

II. Physicochemical Properties (Dihydrate, for Injection)

Parameter | Data

Appearance | White to off-white loose lumps or powder

Solubility | Very soluble in water (>100 mg/mL), easily soluble in methanol, slightly soluble in ethanol; aqueous solution is stable at pH 4-8, easily degraded under strong acid conditions

Dissociation Constant (pKa) | 8.8 (pyridine ring), improved plasma stability after increased water solubility

Melting Point | 210-215℃ (decomposition)

Stability | Stable for 24 months at 25℃/60% RH, store in a sealed, cool, and dry place; aqueous solution should be prepared immediately before use, avoid strong light and high temperature

Chiral Characteristics | Contains 1 chiral center (sulfinyl S atom), is a racemate (R/S configuration), optical purity >99.5%

Partition Coefficient (logP) | 3.2 (anhydrous form, predicted value)

BCS Classification | Not applicable (injectable dosage form, BCS classification is not required)