February 17, 2025

Cephalexin Monohydrate

Product Name Cefalexin Powder
Shelf Life 2 years
Tests BP2012  Specifications Observations
Appearance White or almost white, crystalline powder

Almost white crystalline

powder

Solubility Sparingly soluble in water,practically insoluble in ethanol(96%) Conform
Identification IR spectrum should be concordant with the standard Conform
PH 4.0 to 5.5 4.9
Specific optical rotation +149° to +158°(anhydrous substance) +155°
Related substances
Impurity B: Not more than 1.0%(compared to the area of the 2nd peak) <1.0%
Any other impurity: Not more than 1.0%(compared to the area of the 1nd peak) <1.0%
Total impurity: Not more than 3.0% <3.0%
N,N-Dimethylaniline Maximum 20 ppm Not used in process
Water 4.0%to 8.0%,determined on 0.300 g. 6.1%
Sulphated ash Maximum 0.2%, determined on 1.0 g. <0.1%
Assay 95.0% to 102.0% of C16H17N3O4S (anhydrous substance) 99.5%
Density 0.27g/ml
Remark:The product complies as per above BP2012 specifications.

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