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Specifications

Cefeprime dihydrochloride
CAS NO: 123171-59-5
Chemical Name:
1-[[(6R,7R)-7-[2-(2-Amino-4-thiazolyl)glyoxylamido]-2-carboxy-8-oxo-5-thia-1-zabicyclo[4.2.0]oct-2-en-3-yl]methyl]-1-methylpyrrolidiniumchloride,72-(Z)-(O-methyloxime),monohydrochloride,
Molecular Formula: C19H24N6O5S2.2ClH.H2O
Molecular Weight: 571.50.
Appearance: white crystalline powder
Identification: Infrared
Packing: 10kg/Tin
Storage: It should be stored at dry, cool and avoid right.
Source of Test Method: USP 30
Contents of Testing
Requirements
Results of Analysis
Description
White to yellowish or crystalline Powder
Meets the requirements
Identification
Meets the requirements
Meets the requirements
Water
3.0-4.5%
3.2%
Crystallinity
Meets the requirements
Meets the requirements
Bacterial endotoxins
<0.04EU/mg
Meets the requirements
Residue on Ignition
≤0.1%
0.08%
Sterility
Meets the requirements
Meets the requirements
N-methylpyrrolidine
≤0.3%
Not detected
Heavy Metals
≤20ppm
<20ppm
Related compounds
Cefepime related compound A
≤0.3%
Not detected
Cefepime related compound B
≤0.2%
Not detected
Any other impurity
≤0.1%
0.04
Assay
825~911ug/mg
856 ug/mg