Cefotaxime Sodium

CAS number：63527-52-6

Molecular formula：C16H17N5O7S2

molecular weight：455.46500

Chemical structure：

Product Name	Cefotaxime Sodium
Shelf life	2 years
Test items	Standard	Test results
Description	White,off-white to pale yellow crystalline powder,ordorless,or slight special ordor	White,crystalline powder slight special ordor
Clarity and color solution	1.The solution is clear 2.Absorbance≤0.20	Conforms 0.08
Identification	1.IR spectrum is concordant with RS	Conforms
	2.The retention time of the principal peak in HPLC Chromatogram is identical with RS	Conforms
	3.It responds to the tests for sodium	Conforms
Specific optical rotation	+58.0o-+64.0o	+60.0o
pH	4.5-6.5	5.6
Loss on drying	≤3.0%	2.1%
Chromatogram purtiy Individual impurity Total impurities	≤1.0% ≤3.0%	0.41% 1.68%
Sterility	Conforms	Conforms
Bacterial endotoxins	≤0.20EU/mg	Conforms
Visible particles	≤0.20EU/mg	Conforms
Particulate matter	≥10μm: ≤2000pc/g ≥25μm: ≤200pc/g	330pc/g 30pc/g
Residue solvent	Conforms	Conforms
Bulk Density	≥0.45g/ml	0.47g/ml
Tapped Density	≥0.65g/ml	0.68g/ml
Assay	It contains the equivalent of not less than 916μg/mg and not more than 964μg/mg of cefotaxime,C16H17N5O7S2 calculated on the anhydrate basis.	943μg/mg
CONCLUSION:THE RESULTS CONFORM WITH USP 35 STANDARD

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