Original
By certification 
Cefuroxime Sodium Salt Sterile CAS 56238-63-2 
Product Name: Cefuroxime Sodium Salt Sterile
Synonyms: Cefuroximum natricum
CAS Number: 56238-63-2
Characteristics: White or almost white powder.
Assay and Potency: 855µg/mg ~ 1000µg/mg calculated by Cefuroxime (C16H16N4O8S) in USP;
96%~102% in BP standard
Formula: C16H15N4NaO8S
Package: “10Kg/Tin/Ctn” or “7Kg/Tin, 2Tins/Ctn”
Usage: Cefuroxime Sodium is a cef anti-Bacterial substance with a broad spectrum. It is mainly used to produce Cefuroxime Sodium intravenous Injections.
RS of Cefuroxime Sodium:
COA—Cefuroxime Sodium Sterile
TEST |
REFERENCE |
RESULTS |
Description |
A white to slight yellow powder |
Complies |
Identification |
The retention time of sample corresponds to the retention time of cefuroxime RS. |
Complies |
Yields the flame reaction of sodium salts |
Complies |
|
PH |
6.0~8.5 |
7.1 |
Clarity of solution |
≤ 1 # |
|
Color of solution |
≤ Y6 or YG6 |
≤ 2 # |
Water |
≤ 3.5% |
2.1% |
Residual solvents |
Methanol ≤ 0.3% Ethanol ≤ 0.5% Acctone ≤0.5% |
0.08% 0.19% 0.19% |
Bacterial endotoxins |
< 0.10 EU/mg |
Complies |
Sterility |
Should be sterile |
sterile |
Related substances |
Individual Impurity ≤ 1.0%; Total impurities ≤ 3.0% |
Complies Complies |
Cefuroxime polymer |
≤ 0.2% |
0.02% |
Visible parlicles |
≤ 5 /3g |
Complies |
2-Ethylhexanoic acid |
≤ 0.5% |
0% |
Assay(Cefuroxime) |
855ug/mg ~ 1000ug/mg |
949ug/mg |
Conclusion: The product complies as per above USP38 specifications. |
