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
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
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