Cefuroxime Acid
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Title CEFUROXIME ACID |
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Formula |
C16H16N4O8S |
Structural formula:
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Molecular weight |
424.40 |
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IUPAC name |
Z)-(6R,7R)-3-(carbamoyloximethyl)-7-[2-(2-furil)-2-(metoxy-imino)acetamide]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxilic acid |
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CAS number |
55268-75-2 |
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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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Identification IR |
Spectrophotometric (IR) |
Positive |
Internal |
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Water content (400 mg) |
Titrimetric (KF) |
Not more than 1.0% |
Internal |
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Color (10% w/v in NaHCO3 5% w/v, Abs450 nm) |
Spectrophotometric (UV) |
Not more than 0.045 AU |
Internal |
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Assay (on anhydrous substance) |
HPLC |
Not less than 98.0% |
Internal |
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Impurities (area %): maximum unknown |
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Not more than 0.10% |
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I. SMIA |
HPLC |
Not more than 0.10% |
Internal |
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7-ACA |
Not more than 0.10% |
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A. cefuroxima decarbamoile |
Not more than 0.3% |
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B. 7-ACA-SMIA (cefuracetime) + E. Cefuroxime isomer E |
Not more than 0.5% |
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C. 7-ADCA-SMIA |
Not more than 0.3% |
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H. Lactone |
Not more than 0.5% |
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Total impurities |
Not more than 1.5% |
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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 0.05 EU/mg |
Internal |
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