Home » Sourcing Solutions » Diphenhydramine HCL BP
PRODUCT SPECIFICATIONS | |
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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 |
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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 |
-NMT0.5% -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) Monochlorobenzene Acetone Isopropyl Alcohol |
-NMT 360 ppm -NMT 5000 ppm -NMT 5000 ppm |