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TESTING ITEMS |
SPECIFICATIONS |
RESULTS |
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Appearance |
white or almost white powder |
Conforms |
|
Identification |
IR: the infrared absorption spectrum exhibits maximum only at the same wavelengths as that of the standard sample |
Conforms |
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It gives reaction of chlorides |
Conforms |
|
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Solubility |
Freely soluble in anhydrous ethanol and in methanol, slightly soluble in acetone, very slightly or slightly soluble in water |
Conforms |
|
Loss on drying |
≤0.50% |
0.05% |
|
Sulphated ash |
≤0.10% |
0.04% |
|
Related substances |
Impurity B ≤0.15% |
N.D. |
|
Impurity E ≤0.05% |
N.D. |
|
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Unspecified impurity ≤0.10% |
0.06% |
|
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Total impurities ≤0.30% |
0.20% |
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Assay(dried substance) |
99.0%~101.0% |
99.5% |
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Residual solvents |
Ethyl Acetone ≤5000ppm |
121ppm |
|
Isopropyl alcohol ≤5000ppm |
N.D. |
|
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Trichloromethane ≤60ppm |
3ppm |
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Conclusion: The Product Conforms to USP/EP.
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