Product Name
|
Cefradine
|
Shelf Life
|
2 years
|
Tests
|
BP2012 Specifications
|
Results
|
Appearance
|
White or slightly yellow powder,hygroscopic powder.
|
White powder,
hygroscopic powder.
|
|
Solubility
|
Slightly soluble in water,practically insoluble in ethanol 96 percent and in hexane.
|
Conform
|
|
Identification
|
IR spectrum should match with that of standard
|
Conform
|
|
Clarity of solution
|
Solution S is not more opalescent than reference suspension II
|
Conform
|
|
Absorbance at 450nm
|
Not more than 0.6
|
0.3
|
pH
|
Between 3.0 and 6.0
|
4.7
|
|
Specific optical rotation
|
Between +80.0°and +90.0°(anhydrous substance)
|
+85°
|
|
Related substances
|
|
|
|
Impurity B
|
Maximum0.25%
|
＜0.25%
|
|
Impurities A, C, D, E, F, G
|
Maximum0.25%
|
＜0.25%
|
|
Any other impurity
|
Maximum0.5%
|
＜0.5%
|
|
Total impurity
|
Maximum2.0%
|
＜2.0%
|
N,N-Dimethylaniline
|
Maximum 20 ppm
|
Not used in process
|
Water
|
Maximum 6.0%，determined on 0.300 g.
|
4.3%
|
|
Sulphated ash
|
Maximum 0.2%
|
＜0.1%
|
|
Assay
|
|
|
|
cefradine
|
Minimum 90.0%
|
96.8%
|
|
cefalexin
|
Maximum 5.0%
|
1.5%
|
|
4′,5′-dihydrocefradine
|
Maximum 2.0 %
|
1.0%
|
|
Sum of cefradine, cefalexin and 4′,5′-dihydrocefradine
|
Minimum 96.0%.and maximum 102.0%(anhydrous substance)
|
99.3%
|
