Product name: Cefamandole Nafate (sterile)

Expiry date: 3 Years

Test Item

Acceptance Criteria

Description

A white or almost white crystalline powder

Specific optical rotation

-35.0°~-44.0°

Identification

1.     The retention time of the major peak for cefazolin in the Sample corresponds to that of the standard solution, as obtained in the Assay.

2.     The absorbance should be maximum in 269±2nm.

3.     The IR spectrum should match with that of reference

4.     Yields the flame reaction of sodium salts.

pH

4.0~6.5

Clarity of solution

≤1#

Absorbance (475nm)

≤0.03

Cefamandole nafate

Not more than 9.5 on the anhydrous basis.

Related substances

Any impurity≤1.0%

Total impurities≤3.0%

Residual solvents

Methanol≤0.3%

Acetone≤0.5%

Ethyl acetate≤0.5%

Isopropanol≤0.5%

Acetonitrile≤0.041%

Dichloromethane≤0.06%

2-Ethylhexanoic acid

≤0.3%

Water

≤1.0%

Particulate contamination

No visible foreign matter.

Particulate matter

≥10um    ≤6000/g

≥25um    ≤600/g

Heavy metal

≤0.001%

Bacterial endotoxins

Less than 0.15EU/mg of cefamandole.

Sterility

Should be sterile

Assay

Not less than 84.0% and not more than 93.0% of cefamandole on the anhydrous basis.

Specific volume

Report the result

Conclusion

The product complies referred above ChP2015 specification.