|
Item |
Standard |
Results |
Remark |
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Appearance |
Yellow crystalline powder |
Conforms |
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Solubility |
Freely soluble in Water, sparingly soluble in ethanol |
Conforms |
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Identification |
A-The retention time of the main peak is consistent with that of main peak in the control map |
Conforms |
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B-Color reaction: Conforms |
Conforms |
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C-Chloride reaction: Conforms |
Conforms |
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pH |
2.3 ~ 2.9 |
2.6 |
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Water |
≤ 2.0% |
0.75% |
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Light absorbing impurities |
430nm: ≤ 0.50 %(Calculated on anhydrous substance) |
0.12 |
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Light absorbing impurities |
490nm: ≤ 0.20 %(Calculated on anhydrous substance) |
0.10 |
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Sulfated ash |
≤ 0.2 % |
0.13% |
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Residual Methanol |
≤ 0.3% |
0.15% |
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Impurity |
Impurity A ≤0.5% |
0.17% 0.32% |
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Impurity B ≤1.0% |
0.70% |
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Impurity C ≤2.0% |
1.35% |
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Impurity D ≤0.2% |
ND |
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Impurity E ≤0.2% |
ND |
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Any other impurity ≤0.1% |
ND |
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Sum of impurities D,E&F ≤1.0% |
0.04% |
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Total impurities ≤3.5% |
2.26% |
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Assay (on dry basis) |
94.5-102.0% |
95.8% |
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Conclusion |
The batch product complies with BP2019/EP10.0 Standard |
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