Category:
Sera and Vaccines
CAS NO:
21187-98-4
Standard:
ChP,USP,BP,EP,
ITEMS |
RESULTS |
Characteristics |
A white powder |
Solubility |
Practically insoluble in water: freely soluble in methylene chloride; Sparingly soluble in acetone(96%); slightly soluble in alcohol (96%) |
M.P |
164.0-164.5°C |
Identification |
Conform to the spectrum of the CRS Gliclazide |
Heavy metals |
<10ppm |
Impurity B |
0.3ppm |
Related substances |
<0.10% |
<0.10% |
|
0.13% |
|
Loss on drying |
0.1% |
Sulphated ash |
0.01% |
Residual solvents |
Below LOQ |
Below LOQ |
|
Assay (on dried basis) |
99.5% |
Conclusion
|
The test results conform with EP/BP/CP
|