Items

SPECIFICATIONS

Description

White or almost white crystalline powder

Solubility

Practically insoluble in water or ethanol, slightly soluble in rare hydrochloric acid

Identification

(A) IR

Should be indentical to that of RS

(B)HPLC

Should be indentical to that of RS

UV

Maximum absorption: 266nm and 325nm

The clearity and color of the sodium hydroxide solution

Meets the requirements

Chromatographic purity

Any individual impurity: NMT 0.3%

Total impurities: NMT 1.0%

Residual solvents

Methanol: NMT 0.3%

Ethyl acetate: NMT 0.5%

DMF: NMT 0.088%

Acetic acid: NMT0.5%

Chloride

Meets the requirement (less than 0.014%)

Water

NMT 2.0%

Residue on ignition

NMT 0.2%

Heavy metals

NMT 20PPM

Assay

98.5%-101.5% of C12H9N3O(on dried basis)

Bacterial endotoxins

NMT 100EU/mg

Microbial count

NMT 100CFU/g