56180-94-0 Acarbose C25H43NO18
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Items |
Specification |
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Characters |
White or yellowish amorphous powder , hygroscopic. |
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Identification |
a. HPLC |
The principal peak in the chromatogram obtained with the test solution is similar in retention time and size to the principal peak in the chromatogram obtained with reference solution. |
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b. IR |
Consistent with reference standard |
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Specific optical rotation |
+168°~+183° (anhydrous substance) |
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water |
≤4.0% |
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pH |
5.5~7.5 |
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Absorbance |
≤0.15. NMT 0.15 at 425nm. |
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Sulphated ash |
≤0.2% |
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Heavy Metals |
≤20ppm |
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Related Substances |
Total Impurity |
≤3.0% |
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Any Impurity |
≤0.2% |
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Impurity A |
≤0.6% |
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Impurity B |
≤0.5% |
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Impurity C |
≤1.5% |
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Impurity D |
≤1.0% |
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Impurity E |
≤0.2% |
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Impurity F |
≤0.3% |
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Impurity G |
≤0.3% |
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Impurity H |
≤0.2% |
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Assay (anhydrous substance) |
96.0%~102.0% |
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Microbiological purity |
Not more than 1000 aerobic bacteria per 1 g |
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Not more than 100 fungi per 1 g |
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Absence of Escherichia coli per 1 g |
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Conclusion |
Conform to the EU Specification |
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