cefepime
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Certification of Analysis
 
 
Product Name
Cefepime hydrochloride 
Catalog No
SC-19596
CAS Number
88040-23-7
Quantity
10g
Batch No
20130117
Product Date
2013.01.17
Date of analysis
2013.01.17

 
 
 
 
 
 
 
 
 
 
Items of analysis
Specification
Results
Appearance 
Off-white to yellowish crystalline powder       
Off-white crystalline powder     
Chemical reaction (1)
should be positive
Positive
HPLC
the retention time of the main peak in 
the preparation of assay correspond
with the main peak in the
chromatogram of the standard preparation
Conforms
Chemical reaction (2)
should be positive
Positive
Ph 
1.6-2.1
1.9
Clarity 
≤1#
Clear
Color 
≤Y8# or YG8#
≤4#
Water
3.0-4.5%
4.4%
Residual solvent
Methanol≤0.3%
Acetone≤0.5%
Dichloromethane≤0.06%
0.2%
0.0%
0.0%
N-methylpyrrolidine
≤0.5%
0%
Related substance
Individual impurity≤0.5%
Total impurity≤1.0%
0.1%
0.3%
Heavy metal
≤20ppm
Conforms
Residual on ignition
≤0.1%
0.1%
Particulate matter
Should conform
Conforms
Assay
98.0%min
99.5%
Attention
Protect from the light and Store in a cool dry place.
Remark
For Laboratory use only, not for drug, household or other use
Conclusion
Conform with specification

 
Analyst: Carlos Lin                                              Check: Sally Chen                                                           Date: 2013-01-17
 

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