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品名(name) |
马来酸噻吗洛尔（Timolol Maleate） |
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报告编号( Analytical Report No.) |
20220316 |
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批号（Batch No.） |
20220316 |
化验单号（Analytical Report No.) |
20220316 |
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数量（Batch Quantity） |
100kg |
送检日期（Date Of Sampling） |
2022/03/16 |
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规格(Specification) |
1kg |
报告日期(Date Of Reporting) |
2022/03/18 |
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依据(According As) |
USP34 |
有 效 期(Date Of Expiry) |
2024/03/16 |
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检验项目（Text ltems） |
标准规定(Specification) |
检验结果(Result)
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性状(Description) |
White to practically white, odorless or practically Odorless ,Power |
Practically White crystalline Power |
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鉴别 (Identfication) |
Shall comply with USP34 tests,A and B |
Complies |
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旋光度 (Specific rotation) |
Between -11.7º and -12.5º |
-11.8 º |
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炽灼残渣 (Residue on ignition) |
Not more than 0.1% |
0.07% |
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重金属 （Heavy Metal） |
Not more than 0.002% |
<0.002% |
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干燥失重 (Loss on drying) |
Not more than 0.5% |
0.04% |
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pH(20mg/ml) |
Between 3.8 and 4.3 |
4.1 |
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色谱纯度（Chromatographic purity) |
No secondary spot is more intense than 0.4% and the sum of the intensities of the secondary spots,excluding any having intensities less than 0.1%, does not exceed 1.0%
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CComplies
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含量测定 （Assay） |
Not less than 98.0% and not more than 101.0% |
99.6%
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结论(Conclusion) |
符合规定 In conformity with USP34
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