Cefotaxime Acid
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Title CEFOTAXIME ACID |
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Formula |
C16H17N5O7S2 |
Structural formula:
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Molecular weight |
455.47 |
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IUPAC name |
(6R, 7R)-3-[(acetyloxy)methyl]-7-[[(Z)-2-(2-aminothiazol-4-yl)-2-(methoxyimino)acetyl]amino]-8-oxo-5-thia-1-azabicyclo4.2.0oct-2-ene-2-carboxylic acid |
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CAS number |
63527-52-6 |
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test |
method |
specification |
ref. MeTH. |
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Description |
Visual |
white or almost white crystalline powder |
Internal |
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Water content (300 mg) |
Titrimetric (KF) |
Not more than 3.0% |
Internal |
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Color (10% w/v in NaHCO3 4.6% w/v, Abs430nm) |
Spectrophotometric (UV) |
Not more than 0.100 AU |
Internal |
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Clarity (1.0 g + 184 mg NHCO3 + 10 ml H2O + 1ml glacial acetic acid; verify immediately) |
Visual |
Not more than RSI |
Internal |
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Assay (on as is base) |
HPLC |
Not less than 90.0% |
Internal |
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Impurities (area %): maximum unknown |
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Not more than 0.10% |
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ATMAA-carboxamide |
HPLC |
Not more than 0.2% |
Internal |
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7-ACA |
Not more than 0.35% |
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B. Desacetyl cefotaxime |
Not more than 0.5% |
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A. Desacetoxy cefotaxime |
Not more than 0.6% |
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E. Desacetylcefotaxime lactone |
Not more than 0.3% |
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D. E-cefotaxime |
Not more than 0.3% |
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F. Cefotoxime dimer |
Not more than 0.2% |
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G. ATA-cefotaxime |
Not more than 0.2% |
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C. Impurity C |
Not more than 0.5% |
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Specified impurity rrt 2.6 - 2.8 |
Not more than 0.5% |
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Total impurities |
Not more than 3.0% |
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Residual solvents |
GC |
Complying to ICH limit |
EP |
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Any Other Relevant Residual from synthesis |
Not applicable |
Complies* |
Not applicable |
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Bacterial Endotoxins |
LAL test (Gel clot) |
Less than 0.025 EU/mg |
Internal |
