Item

Standards

Results

Characters

White or almost white crystalline powder

White crystalline powder

Identification

Infrared absorption:

Must similar to reference standard

Conforms

Ultraviolet absorption:

Must similar to reference standard

Conforms

Test for potassium: Must be positive

Positive

Water

NMT 0.5%

0.1%

Heavy metals

NMT 0.001%

Conforms

Chromatographic purity

Any individual impurity NMT 0.2%

0.01%

Total impurities NMT 0.5%

0.04%

Residual solvents

Cyclohexane NMT 0.1%

0.007%

Isopropyl alcohol NMT 0.2%

0.03%

Assay(HPLC)

98.5~101.0%

99.2%