79350-37-1 CEFIXIME Cefiximide USP
Name of Product |
Cefixime trihydrate |
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Lot No. |
KWK1605825 |
Quantity. |
25kgs |
Test date |
May,08,2016 |
Report date |
Jun,14,2016 |
Mfg date |
May,08,2016 |
Retest. date |
Apr,2018 |
Quality Standard |
USP34 |
Tests |
Standards |
Results |
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Appearance |
White or light yellow crystalline powder |
Light yellow crystalline powder |
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Identification (IR) |
corresponding |
complies |
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Specific rotation |
Between-75°and-88° |
-81° |
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pH |
Between2.6 and 4.1 |
3.6 |
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crystallinity |
Meets the requirements |
complies |
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water |
Between9.0% and 12.0% |
10.8% |
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Chromatographic purity Any individual impurity Total impurities |
Not more than 1.0% Not more than 2.0% |
0.09% 0.09% |
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Residual solvent Acetone Ethyl acetate |
Not more than 0.5% Not more than 0.5% |
Not detected 0.3% |
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Heavy metals |
Not more than 10pm |
<10pm |
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Tapped density |
0.7—0.8 g/ml |
0.74g/ml |
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Bulk density |
|
0.65g/ml |
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Assay On the anhydrous basis |
Between 950μg/mg and1030μg/mg |
985μg/mg |
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Conclusion: The material complies with USP34 |
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Prepared |
liwei |
checker |
Cheng ze |
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