Acarbose 99% acarbose high purity acarbose
Item |
Specification |
Results |
|
Characters |
White or yellowish, amorphous powder, hygroscopic. Very soluble in water, soluble in methanol, practically insoluble in methylene chloride. |
Complies |
|
Identification |
As per EP8.0 |
Complies |
|
Absorbance |
Max. 0.15 at 425nm for solution S. |
0.02% |
|
Assay(on anhydrous basis) |
95.0-102% |
99.2% |
|
Water |
4.0% max |
2.1% |
|
Specific optical rotation |
+168 - +183° |
+168° |
|
Sulfated ash |
0.2% max |
0.2% |
|
pH |
5.5-7.5 |
7.0 |
|
Heavy metals |
20ppm max |
Complies |
|
Related substance |
Impurity A |
Max 0.6% |
0.5% |
|
Impurity B |
Max 0.5% |
Negative |
|
Impurity C |
Max 1.5% |
0.1% |
|
Impurity D |
Max 1.0% |
0.4% |
|
Impurity E |
Max 0.2% |
Negative |
|
Impurity F |
Max 0.3% |
Negative |
|
Impurity G |
Max 0.3% |
Negative |
|
Impurity H |
Max 0.2% |
Negative |
|
Any other impurities |
Each impurities max 0.2% |
Complies |
Total impurities |
3.0% max |
1.1% |
|
Total plate connt |
≤1000cfu/g |
<10cfu/g |
|
Mould |
≤100cfu/g |
<10cfu/g |
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