Tests	BP2012 Specifications	Observations
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
Indent cation	1R spectrum should match with that of standard	Conform
Appearance of solution
Clarity of solution	Solution S is not more opalescent than referenee suspension 11	Conform
Absorbance al 450 nm	Not more than 0.6	0.3
pH	Between 3.0 and 6.0	4.9
Specific optical rotation	Between +80.0°and +90.0°(anhydrous substance)	+84°
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%
MN-Dimethylani1ine	Maximum 20 ppm	Not used in process
Water	Maximum 6.0%, determined on 0.300 g.	4.1%
Sulphated ash	Maximum 0.2%	0.1%
Assay
cefradine	Minimum 90.0%	96.5%
cefalexi n	Maximum 5.0%	1.5%
4',5'-dihydrocefradine:	Maximum 2.0 %	1.6%
Sum of cefradine. cefalexin and 4',5'-dihydrocefradine	Minimum 96.0%.and maximum 102.0%(anhydrous substance)	99.6%
Tapped Density		0.94g/ml
Remark: The product complies as per above BP2012 specifications.

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