Category:
Prophylactic Biological Products
CAS NO:
21187-98-4
Standard:
ChP,USP,BP,EP,
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Basic Info
CAS Number
21187-98-4
Pharmacopoeia
ChP,USP,BP,EP
Grade
Pharmaceutical Grade
Is Manufacturer
YES
Packaging & Delivery
Packaging Specification
25kg/fiber drum or 25kg/carton
Delivery Cycle
1 week
Product Description
|
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
|
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