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质量报告单
CERTIFICATE OF ANALYSIS
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Product Name |
Ibuprofen(75Grade) |
Batch No. |
20231020 |
|
MFG. Date |
2023.10.20 |
Testing Date |
2023.10.20 |
|
Retest Date |
2023.10.20 |
Standard |
USP36 |
|
ITEMS |
SPECIFICATIONS |
RESULTS |
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Characteristics |
White crystalline powder |
Conforms |
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Solubility |
Practically insoluble in water ;very soluble in alcohol , in methanol ,in acetone, and in chloroform; slightly soluble in ethyl acetate |
Conforms |
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Identification AIR
B.UV
C.HPLC |
a. Sample IR spectrum corresponds to that of the standard |
Conforms |
|
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B. Sample UV spectrum does not differ from that of the standard by more than 3.0% |
Conforms |
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C. Retention time corresponds to that of the standard |
Conforms |
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Water Content |
not more than1.0% |
0.12% |
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Heavy Metals |
not more than0.002% |
＜0.002% |
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Residual on Ignition |
not more than0.5% |
0.02% |
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Chromatographic Purity |
2-[3-(2-methylpropyl)phenyl]propanic acid :not more than0.15% |
0.03% |
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|
2-[4-methyl phenyl]propanic acid :not more than0.15% |
0.0% |
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2-[4-ethyl phenyl]propanic acid :not more than0.15% |
0.01% |
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2-[4-propylphenyl]propanic acid :not more than0.15% |
0.01% |
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2-[4-butylphenyl]propanic acid :not more than0.1% |
0.0% |
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Any unknown impurities not more than 0.05% |
0.02% |
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Total impurities :not more than 0.6% |
0.07% |
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4-Isobutylacetophenone |
Not more than 0.1% |
0.0% |
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Assay(dried basis) |
97.0%-103.0% |
100.1% |
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ADDITIONAL TESTS |
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Residual solvents (Petroleum ether) |
Not more than 250ppm |
79ppm |
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Bulk Density |
0.25-0.50g/ml |
0.43g/ml |
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Tapped density |
0.50-0.75g/ml |
0.64g/ml |
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Median particle size |
60-90um |
89.84um |
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Conclusion |
The product meets USP36 specifications |
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