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Cefepime Hydrochloride or Cefepime Hcl with L-Arginine Sterile Injection Grade
CAS 123171-59-5 
Product Name: Cefepime Hydrochloride L-Arginine Sterile Injection Grade
Synonyms: Cefepime Hcl, Cefpime Hydrochloride Arginine
CAS Number: 123171-59-5
Characteristics: A white to slight yellow powder
Content: 825µg/mg ~ 911µg/mg Cefepime (C19H24N6O5S2)
Formula: C19H25ClN6O5S2·HCl·H2O
Molecular Weight: 571.50
Standard: USP38
HSCODE: 2941905990
Package: 5KG/Tin, 2Tin/Carton; 10Kg/Tin/Carton
Usage: Cefepime Hydrochloride (Cefepime Hcl) is usually not in pure form. In our everyday life, It will add some L-Arginine to make Cefepime Hydrochloride L-Arginine Sterile for injection. Cefepime Hydrochloride (Cefepime Hcl) is a raw material belongs to cephalosporin-antibiotic.
COA—Cefepime Hydrochloride L-Arginine Sterile Injection GradeTesting Item |
Standard |
Result |
Appearance |
A white to slight yellow powder |
Complies |
Identification |
Should Comply |
Complies |
PH |
4.0~6.0 |
4.8 |
Clarity of solution |
≤ 1 # |
Clear |
Colour of solution |
≤ Y7 or YG7 or OY7 |
< YG2 |
Water |
≤ 4.0% |
2.2% |
Related substances |
Related Compound A ≤ 0.5% |
0.01% |
Related Compound B ≤ 0.5% |
0.01% |
|
Any other individual Impurity ≤ 0.5% |
0.04% |
|
Total Impurity ≤ 2.0% |
0.20% |
|
N-Methylpyrrolidine |
≤ 1.0% |
Complies |
Uniformity of dosage units |
Sample there different points, and the assay difference should not more than 1.5% |
Argine±0.2% Cefepime±0.2% |
Visible particles |
Should comply |
Complies |
Particulate matter |
≥ 10um ≤3000/g ≥ 25um ≤300/g |
38/g 2/g |
Bacterial endotoxins |
< 0.060 EU/mg |
Complies |
Sterility |
Should be sterile |
Complies |
Assay |
34.05%~ 42.0% of Arginine ≥ 83.0 of Cefepime |
Argine±36.9% Cefepime±85.5% |
