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CERTIFICATE OF ANALYSIS
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Product Name |
Trimethoprim |
Batch No. |
20200525 |
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Batch Quantity |
25kgs |
Net weight |
25kg/drum |
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Manufacture date |
May 25,2020 |
Expiry date |
May 24,2022 |
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Analysis date |
May 25,2020 |
Release date |
May 25,2020 |
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Pharmacopoeial Standard |
BP2010 |
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ITEMS |
SPECIFICATIONS |
RESULTS |
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Characters |
A white or yellowish-white powder |
Yellowish-white powder |
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Solubility |
Very slightly soluble in water, slightly soluble in alcohol, practically insoluble in ether |
Very slightly soluble in water, slightly soluble in alcohol, practically insoluble in ether |
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Melting point |
199-203℃ |
200.0-200.5℃ |
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The infrared absorption spectrum |
Is concordant with the spectrum of trimethoprim EPCRS |
Is concordant with the spectrum of trimethoprim EPCRS |
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Appearance of solution |
Not more intensely colored than reference solution BY7 |
Less intensely colored than reference solution BY7 |
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Heavy metals |
≤20ppm |
<20ppm |
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Related substances |
≤0.2% |
<0.2% |
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Loss on drying |
≤1.0% |
0.2% |
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Sulphated ash |
≤0.1% |
0.02% |
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Assay |
98.5-101.0% |
99.8% |
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Results |
The commodity meets the standard of BP2010 |
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