Tests Item

Standard

Appearance

White Or Almost White Crystalline Powder

Solubility

Practically insoluble in water,very slightly soluble in methylene chloride and acetone,  practically insoluble in ethanol(96percent),It dissolves in dilute solutions of alkali hydroxides.

Identification

A:Ultraviolet and visible absorption spectrophometry:Absorption maxima at 266nm and 274nm,Absorbance ratio A226/A274=2.0 to 2.4   B:Infrared absorption spectrophometry:Comparison glipizide CRS   C:Thin-layer chromatography:The principal spot in the chromatogram obtained with the test solution is similar in position and size to the principal spot in the chromatogram obtained with the reference solution

Loss on dying

NMT0.5%

Residue on ignition

NMT0.2%

Related substances

Impurity A:NMT0.3%          Impurity D: NMT0.1%

Impurity E:NMT0.1%      Any unspecified impurity:NMT 0.1%

Total impurities:NMT 0.5%

Impurity B

NMT100ppm

Impurity C

NMT0.1%

Residual solvents

Methanol≤3000ppm

Acetone≤5000ppm

Tetrahydrofuran≤720ppm

Assay

98.0%~102.0%(on the dried basis)