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鹽酸乙胺丁醇,1070-11-7,東康源質檢單
CERTIFICATE OF ANALYSIS
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Name of product |
Ethambutol HCl |
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Batch No. |
20230312 |
Quantity |
1000kgs |
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Manufacture date |
2023/03/12 |
Expiry date |
2026/03/11 |
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Test standard |
USP35 |
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Test Items |
Standard |
Result |
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|
Characters |
A white crystalline powder with moisture absorbency, Odorless or almost odorless. |
conforms |
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Identification |
conforms |
conforms |
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|
Specific rotation |
+6.0°- +6.7° |
+6.3° |
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Loss on drying |
≤0.5% |
0.2% |
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Heavy metals |
≤20ppm |
＜20ppm |
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Limit ofaminobutanol |
≤1.0% |
＜1.0% |
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Ordinary impurities |
conforms |
conforms |
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Assay |
98.0%-100.5% |
99.5% |
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Conclusion |
The results conform with USP35 standard |
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