PRODUCT

CEFEPIME FOR INJECTION(Sterile mixture of cefepime hydrochloride and Arginine)

MFG.DATE

Mar.2008

BATCH  NO

2008021301

EXP.DATE

Mar.2010

BATCH

SIZE

113.62KG

ANNLYSED AS PER

USP’27

DATE OF RECEIPT

14.02.2008

DATE OF RELEASE

04.03.2008

Item of analysis

Specification

Results

Appearance

White to pale yellow powder,freely soluble in water

White powder,freely soluble in water

Identification

1)HPLC

conform

2)Positive reaction

Positive reaction

Bacterial endotoxin

It contains not more than 0.06 USP Endotoxin Unit per mg of cefepime

Less than 0.06 USP endotoxin unit per mg of cefepime

PH(100mg of cefepime per ml)

Between 4.0-5.8

4.19

Clarity of solution

conform

conform

Color of solution

conform

conform

Related substances(HPLC)

<=1.0%

0.20

N-nethy1pyrrolidine

<=1.0%

0.01

Water

3.0%～4.5%

3.42

Residue on ignition

<=0.1%

0.04%

Heavy Metals

<=20ppm

<20ppm

Related compounds

1.        Cefepime related compound A

2.        Cefepime related compound B

3.        Any other impurity

Not more than 0.5%

Not more than 0.5%

Not more than 1.0%

0.0%

0.026

0.015

Assay

(C19H24N6O5S2,anhydrous)

78.1～91.1% w/w as cefepime (on anhydrous and arginine free basis

89.14%

conclusion

Conforms to the above standard