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品名 Name |
Tetracaine HCl 鹽酸丁卡因 |
生產日期 MFG.Date |
2020.09.15 |
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批號 Batch No. |
00905 |
報告日期 Report Date |
2020.09.19 |
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檢驗依據 Inspection basis |
USP42 |
復驗期至 Retest Date |
2023.08 |
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Items |
QUALITY STANDARDS |
RESULTS |
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Description 性狀 |
本品白色結晶性粉末，無臭。 Fine white crystalline odorless powder, Has a slightly bitter taste followed by a sense of numbness. |
符合規定 Complies |
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Solubility 溶解性 |
在水中易溶，在乙醇中溶解，乙醚和苯中不溶 Very soluble in water, soluble in alcohol, insoluble in ether and in benzene |
符合規定 Complies |
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鑒別 Identification |
A.紅外應與對照品一致 By IR, should be corresponds to the standard solution. |
符合規定 Complies |
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B. 應顯氯化物的鑒別反應 Should identify significant chloride reaction |
符合規定 Complies |
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C. 含量測定項下，樣品中主峰的保留時間與對照品 一致 The retention time of the major peak of the sample solution corresponds to that of the Standard solution, as obtained in tha Assay. |
符合規定 Complies |
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Heavy metal 重金屬 |
≤10ppm |
Complies 符合規定
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Residue on ignition 熾灼殘渣 |
≤ 0.1% |
0.080% |
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Related Substances 有關物質 |
Aminobenzoic acid ≤ 0.4% Related compound B ≤ 0.4% Related compound C ≤ 0.4% Individual unspecified impurity ≤ 0.4% Total impurity ≤ 0.8% |
Not detected 0.020% 0.020% 0.046% 0.16% |
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水分 Water |
≤2.0% |
0.13% |
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熔點 Melting range |
About 148℃ |
147℃～148℃ |
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殘留溶劑 Residual Solvents |
乙醇 Ethanol≤0.5% |
0.049% |
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丙酮 Acetone≤0.5% |
未檢出Not detected |
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甲苯 Toluine ≤ 0.089% |
未檢出Not detected |
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含量 Assay |
98.0～102.0% |
100.16% |
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結論 Conclusion |
The Sample Complies With Specification of USP42 |
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