Diphenhydramine HCL BP

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Name of Product Diphenhydramine HCL BP
IUPAC Name 2-benzhydryloxy-N,N-dimethylethanamine;hydrochloride
Synonyms Diphenhydramine Hydrochloride, Dimedrol, Carphenamine
CAS No 147-24-0
Molecular Formula C17H22ClNO
Molecular Weight 291.8


SR. No Criteria Limit/Specification
1 Appearance White or almost white, crystalline powder
2 Solubility Very soluble in water, freely soluble in ethanol (96%).
3 Identification
A) IR spectrum
B) Chloride test

-The sample spectrum should be concordant with working standards.
-Should be positive.
4 Appearance of Solution 5.0 % solution is not more intensely coloured than Reference Solution BY6
5 Acidity or Alkalinity NMT 0.5 ml of 0.01M Sodium hydroxide is required to change the colour of the indicator to vellow.
6 Loss on drying NMT 0.5%
7 Related Substances
Impurity A
Any Other Impurity
Total Impurities

-NMT 0.3 %
-NMT 1.0 %
8 Sulphated Ash NMT 0.I %
9 Assay (By Potentiometric Titration) 99.0% to 101.0 % (Calculated on dried substance)
10 Residual Solvent (By GC-HS)
Isopropyl Alcohol

-NMT 360 ppm
-NMT 5000 ppm
-NMT 5000 ppm
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