Items

Requirements

Results

Appearance

White to off white powder

White powder

Solubility

Practically insoluble in water, soluble in dimethylformamide, 

slightly soluble in ethanol(96%) and in methanol

Confirms

Identification

A. M.P. 244~248ºC

244.5~245.5ºC

B. IR should comply

Confirms

C. TLC should comply

Confirms

D. It gives the reaction of non-nitrogen substituted barbiturates.

Confirms

Clarity of solution

The solution is clear and not more intensely colored than

 reference solution Y6

Confirms

Related substance

Total impurities≤0.5%

≤0.29%

Individual impurity≤0.25%

≤0.18%

Loss on drying

≤0.5%

0.07%

Sulphated ash

≤0.1%

≤0.05%

Heavy metal

≤20ppm

<20ppm

Assay

99.0%~101.0%

99.49%

Conclusion: This product conforms to the EP7.0 detection.