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CERTIFICATE OF ANALYSIS
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Product Name |
Paracetamol |
Batch No |
220305 |
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Quantity |
8000kg |
Test Date |
Mar.05,2022 |
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MFG. Date |
Mar.05,2022 |
Exp Date |
Mar.04,2024 |
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Quality Standard |
BP2010/USP35 |
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Test Items |
Specification |
Test Results |
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Characteristics |
A white crystalline powder |
A white crystalline powder |
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Identification |
Positive |
Positive |
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Melting range |
168~172℃ |
169.2~170.3℃ |
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Related substance |
Impurity J not more than 10ppm |
<10ppm |
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Impurity K not more than 50ppm |
<50ppm |
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Impurity F not more than 0.05% |
<0.05% |
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Any other impurity not more than 0.05% |
<0.05% |
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|
<0.1% |
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Heavy metals |
Not more than 20ppm |
<10ppm |
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Loss on drying |
Not more than 0.5% |
0.1% |
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Sulphated ash |
Not more than 0.1% |
0.03% |
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|
Assay |
99.0~101.0% |
99.8% |
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Conclusion |
Complies with BP2010/USP35 |
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Total of other impurity not more than 0.1%
