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Cefepime Arginine
| ITEMS | LIMIT |
| Description | White to pale yellow powder; Freely soluble in water |
| Identification | The intensity and Rf of the spot in the chromatogram of the test solution correspond with the chromatogram of the standard solution |
| The retention time of the main peak in the preparation of assay correspond with the main peak in the chromatogram of the standard preparation | |
| pH | 4.0-6.0 |
| Water | ≤4.0% |
| Incineration residue | ≤0.1% |
| Heavy metals | ≤0.002% |
| Strange Particals | Should Complies |
| Solubility | 1.98g/6ml of purificated water dissolves within 1 minute max |
| Bulk density | 0.30-0.45g/ml |
| Tapped density | 0.45-0.60g/ml |
| Color of solution | ≤0.1; (10% w/v) Less than Au to 450nm |
| N-Methylpyrrolidone | ≤1.0% |
| Related compounds | |
| A & B | NMT 0.5% |
| Any other impurity | NMT 0.5% |
| Cefepime Assay | 49.8 – 56.6% on dry basis |
| L-Arginine Assay | 35.8 – 40.7 on dry basis |
| Bacterial endotoxins | NMT 0.06 USP UE/mg of Cefepim |
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