Cephradine

ITEMS

STANDARD

RESULTS

Appearance

White to off-white, crystalline powder. Sparingly soluble in water, very slightly soluble in alcohol and in chloroform, practically insoluble in ether.

Off-white powder

Solubility

Complies

Identification

The IR spectrum confirm to that of reference standard

Complies

Crystallinity

Meet the requirements

Complies

PH

3.5 to 6.0

4.8

Specific optical rotation

+80.0° to +90.0°

+86°

Water

Not more than 4.3%

0.043

Limit of Cephalexin

Not more than 5.0%

0.013

Related substance

 7-ADCA

NMT 1.0%

0.00002

 Any other impurity

NMT 2.0%

0.014

 Total

NMT 2.5%

0.015

N,N-Dimethylaniline

Not more than 20 ppm

Not found

Acetone

NMT 0.3%

0.000002

Dichloromethane

NMT 0.06%

Not found

Sulphated ash

NMT 0.2%

0.0008

Assay

99.0% to 105.0%

Cephalosporin Sterile list :

No.

product name

CAS No.

Quality Standard

Packing

Documentation

1

Cefepime Hydrochloride (Arginine)

123171-59-5

USP30, SFDA Standard(Test Run)

25KG/Drum

GMP

2

 Ceftazidime

72558-82-8

CP2005    

25KG/Drum

GMP

3

Cefotaxime Sodium

68401-82-1

USP31,JP15     

25KG/Drum

GMP

4

Cefoperazone Sodium

62893-20-3

CP2005 

25KG/Drum

GMP

5

Cefuroxime Sodium

56238-63-2

USP30,CP2005   

25KG/Drum

GMP

6

Ceftriaxone sodium

73384-59-5

EP6 / USP30 / CP2005

25KG/Drum

GMP