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By certification 
Cefotaxime Sodium Salt Sterile CAS 64485-93-4 
Product Name: Cefotaxime Sodium Salt Sterile
Synonyms: Cefotaximum Natricum
CAS Number: 64485-93-4
Characteristics: A white or slightly yellow powder
Content:
(1) USP Specification: 916µg/mg ~ 964µg/mg, calculate cefotaxime (C16H17N5O7S2)
(2) BP and EP Specification: 96%~101%
Formula: C16H16N5NaO7S2
Package: 5KG/TIN,2TIN/CARTON
Usage: Cefotaxime Sodium Salt Sterile is used to make injections. Its main ability is to kill bacterial by break the cell walls. Then the bacterial dies. Please follow usage dosage and instructions.
COA—Cefotaxime Sodium
TEST |
REFERENCE |
RESULTS |
Description |
A white to slight yellow powder or crystalline powder. Freely soluble in water, sparingly soluble in methanol insoluble in ethanol or chloroform |
Complies |
Specific optical rotation |
+55°~ +64° |
+60° |
Specific absorbance |
360~390 |
381 |
|
Identification |
The HPLC RT should correspond to that of reference standard |
Complies |
The IR spectrum should match with that of reference atandard |
Complies | |
Yields the flame reaction of sodium salts |
Complies | |
PH |
4.5~6.5 |
6.1 |
Clarity of solution |
≤ 0.5 # |
≤ 0.25# |
Light absorption |
≤ 0.20 |
≤ 0.06 |
Related substances |
Individual Impurity not more than 1.0%; Total impurities not more than 3.0% |
Complies |
Particulate matter |
≥ 10um ≤6000/g ≥ 25um ≤600/g |
110/g 16/g |
Cefotaxime polymer |
≤ 0.5% |
0.07% |
Visible parlicles |
≤ 5 /3g |
Complies |
Sterility |
Should be sterile |
sterile |
Bacterial endotoxins |
< 0.050 EU/mg |
Complies |
Water |
≤ 6.0% |
1.0% |
2-Ethylhexanoic acid |
≤ 0.5% |
0% |
Residual solvents |
Methanol ≤ 0.3% Ethanol ≤ 0.5% Acctone ≤0.5% |
Complies Complies Complies |
Specific volume |
Report the result |
3.0ml/g |
Assay (Cefuroxime) |
Not less than 86.0% of Cefuroxime on the anhydrous basis |
95.9% |
Assay (Cefuroxime Sodium) |
96% ~ 102% |
99.9% |
