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Cefuroxime Sodium USP 23
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| TESTS | SPECIFICATIONS |
| Description | White or Yellowish white powder |
|
Identification (HPLC) |
Exhibits a major peak for Cefuroxime (USP) |
| pH | 6.0 - 8.5 |
| Water (K.F) | NMT 3.5 % |
| Specific Rotation | Between +59.0¨¬ and +66.0¨¬ |
|
Absorbance |
Color (430nm,
10%) : NMT 0.150
Clarity (600nm, 10%) : NMT 0.050% |
| Sterility | Meet the requirement under Sterility test (USP) |
| Bacterial Endotoxin | Meet the requirements under Bacterial Endotoxins NMT 0.1EU/mg (USP) |
| Particulate Matter | Meet the requirements under small-volume Injections (USP) |
| Toxicity | Meet the requirements under tests |
| Organic solvent (GC) | Total NMT 0.5% |
| Potency (as anhydrous basis, HPLC) | 900 ~ 1000§¶/§· (as cefuroxime) |