Azilsartan Impurity 16

China [CN]

Quality Control Key Parameters

Detection Method: High-performance liquid chromatography (HPLC) is used, employing a C18 column (e.g., Inertsil ODS-3, 250×4.6mm, 5μm), with a gradient elution using acetonitrile-phosphate buffer (pH 3.0) as the mobile phase. The detection wavelength is 254nm, and the LOQ is typically ≤0.05%.

Limit Requirements:  Referencing ICH Q3A, the limit for a single unknown impurity is generally ≤0.10%, while known specific impurities must comply with drug registration standards, typically controlled at 0.05% - 0.15%.

Reference Standard Specifications: Commercially available reference standards typically have a purity of 95% - 98% (HPLC), packaged in 10mg, 25mg, 50mg, etc., and include COA, NMR, MS, and HPLC chromatograms, used for method validation and impurity quantification.

Physicochemical Properties (1586011-04-2)

Appearance: White to off-white powder

Solubility: Easily soluble in DMSO, slightly soluble in methanol and acetonitrile, sparingly soluble in water

Density: 1.25±0.1 g/cm³ (predicted value)

Boiling Point: 658.9±65.0 °C (predicted value)

pKa: 15.84±0.50 (predicted value)