items

standard

result

appearance

white to off-white crystalline powder

white crystalline powder

identification

consistent with the corresponding control

conform

acidity

1.0ml/g(0.010mol/l naoh) max

conform

alkalinity

1.0ml/g(0.010mol/l hcl) max

conform

loss on drying

0.5% max

0.02%

residue on ignition

0.1% max

0.02%

chlorides

0.014%(140ppm) max

0.014% max

heavy metals

0.001%(10ppm) max

0.001% max

related compounds

impurity a :0.2% max

0.05% max

impurity b(isb) :0.2% max

0.05% max

any other impurity:0.2% max

0.05% max

total impurity:0.5% max

0.05%

assay

96.0%~102.0%

99.30%

residual solvents

chlorobenzene:360ppm max

30ppm max

methanol:3000ppm max

300ppm max

ethano:5000ppm max

500ppm max

conform with usp37