盐酸左旋咪唑

Items

Specifications

Results

Appearance

White or almost white crystalline powder

White crystalline powder

Specific Optical Rotation

﹣121°  to ﹣128°

﹣125°

Infrared absorption spectrophotometry

IR spectrophotometry similar to which of Levamisole Hydrochloride CRS

Conforms

Chlorides

It gives reaction of chlorides

Conforms

pH

3.0 to 4.5

4.18

Related substance

Impurities A,B,C,D,E: For each impurity, not more than 0.2%.

A:0.02%,

B:＜0.01%,

C:ND,

D:0.01%,

E:＜0.01%

Other individual unspecified impurities: not more than 0.10%.

<0.05%

Total of all impurities: not more than 0.3%.

0.04%

Heavy metals

≤20ppm

＜20ppm

Loss on drying

≤0.5%

0.10%

Sulfated ash

≤0.1%

0.05%

Assay (calculated on the dried basis)

98.5% to 101.0%

100.0%

Conclusion

The product complies to the standard of BP/EP