Cephalexin Monohydrate
CAS number:
15686-71-2
Molecular formula:
C16H19N3O5S
molecular weight:
365.4042
Chemical structure:
Details
Product Name
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Cefalexin Powder
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Shelf Life
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2 years
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Tests
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BP2012 Specifications
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Observations
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Appearance
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White or almost white, crystalline powder
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Almost white crystalline
powder
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Solubility
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Sparingly soluble in water,practically insoluble in ethanol(96%)
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Conform
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Identification
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IR spectrum should be concordant with the standard
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Conform
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PH
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4.0 to 5.5
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4.9
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Specific optical rotation
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+149° to +158°(anhydrous substance)
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+155°
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Related substances
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Impurity B:
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Not more than 1.0%(compared to the area of the 2nd peak)
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<1.0%
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Any other impurity:
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Not more than 1.0%(compared to the area of the 1nd peak)
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<1.0%
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Total impurity:
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Not more than 3.0%
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<3.0%
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N,N-Dimethylaniline
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Maximum 20 ppm
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Not used in process
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Water
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4.0%to 8.0%,determined on 0.300 g.
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6.1%
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Sulphated ash
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Maximum 0.2%, determined on 1.0 g.
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<0.1%
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Assay
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95.0% to 102.0% of C16H17N3O4S (anhydrous substance)
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99.5%
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Density
|
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0.27g/ml
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Remark:The product complies as per above BP2012 specifications.
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