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