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CAS NO:
93479-97-1
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Basic Info
CAS Number
93479-97-1
Pharmacopoeia
In-house Standards
Grade
food grade, pharmaceutical grade
Is Manufacturer
No
Samples Provided
NO
Product Description
Glimepiride
CAS No.: 93479-97-1
Appearance: white cyrstalline Powder
Assay(HPLC):99.59%
|
Product Name |
Glimepiride |
Batch No |
20110701 |
|
|
Produce Date |
2011 07 07 |
Report Date |
2011 07 09 |
|
|
Packing Standard |
20kg/drum |
Quantity |
20kg |
|
|
Ref Standard |
USP29 Standard |
Retest Date |
2013 07 07 |
|
|
Results Of Analysis Tests |
||||
|
Test Item |
Analysis Specification |
Result |
||
|
Description |
White to off white power |
white power |
||
|
Identification |
IR (similar to standard) |
Conforms |
||
|
Related substances by HPLC |
||||
|
Impurity A(Cis-isomer) |
≤0.8% |
0.13% |
||
|
Impurity B |
≤0.4% |
0.16% |
||
|
Impurity C |
≤0.1% |
0.05% |
||
|
Impurity D |
≤0.2% |
0.11% |
||
|
Any other impurity |
≤0.1% |
0.08% |
||
|
Total impurity |
≤0.5% |
0.23% |
||
|
Heavy metals |
≤10ppm |
<10ppm |
||
|
Loss on drying |
≤0.5% |
0.19% |
||
|
Sulphated ash |
≤0.1% |
0.07% |
||
|
Assay(HPLC) |
98.0%~102.0% |
99.59% |
||
|
Residual solvents |
To comply the test as pre USP<467> |
Complies |
||
|
Conclusion |
The results Conform with USP29 Standard |
|||
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