ITEM

SPECIFICATIONS

RESULTS

DESCRIPTION

Appearance:White or almost white powder.

Solubility: slightly soluble in water, freely soluble in methanol, sparingly soluble in anhydrous ethanol, slightly soluble in 2-propanol

White powder

Conforms

IDENTIFICATION

Infrared spectrum corresponds to that of EP RS

Conforms

OPTICAL ROTATION

-0.10°~+0.10°

0.00°

Water

≤0.5%

0.11%

Residue on Ignition

≤0.2%

0.05%

Heavy metals

≤0.002%

Conforms

Related substances

Impurity D: NMT 0.3%

Impurity A: NMT 0.15%

Impurity E: NMT 0.15%

Impurity F: NMT 0.15%

Any unspecified impurity: NMT 0.1%

Total impurities: NMT 0.8%

Impurity D: 0.005%

Impurity A: N/D

Impurity E: N/D

Impurity F: 0.03%

Largest unknown impurity: 0.007%

Total impurities: 0.06%

Assay

97.0%~102.0%(anhydrous substance)

99.9%

Residual Solvent

Ethanol≤2000 ppm

400ppm

Conclusion: Quality comply with EP7.4