Diphenhydramine Hydrochloride 147-24-0
Items | Specification | Results |
Appearance | White or almost white crystalline powder | Complies |
Solubility | Very soluble in water,freely soluble in alcohol | Complies |
Identification | UV | Complies |
IR | Complies | |
It responds to the tests for chloride | Complies | |
Melting range | 168-172°C | 168-169°C |
Appearance of solution | Clear, NMTBY6 | Complies |
Acidity or alkalinity | NMT 0,5ml ofO.OlM NaOH | Complies |
Related substance | Impurity A: 0.5% max | 0.04% |
Any other unspecified impurity: 0.3% max | Not Detected | |
Total impurities: 1.0% max | 0.04% | |
Loss on drying | 0.5% max | 0.2% |
Sulphated ash | 0.1% max | 0.04% |
Assay(Dried substance) | 99.0^101.0% | 100.8% |
Residual solvent | Ethanol: 0.5% (5000ppm) max | 0.03% |
Toluene: 0.089% (890ppm) max | 0.0004% |
Diphenhydramine Hydrochloride 147-24-0
Items | Specification | Results |
Appearance | White or almost white crystalline powder | Complies |
Solubility | Very soluble in water,freely soluble in alcohol | Complies |
Identification | UV | Complies |
IR | Complies | |
It responds to the tests for chloride | Complies | |
Melting range | 168-172°C | 168-169°C |
Appearance of solution | Clear, NMTBY6 | Complies |
Acidity or alkalinity | NMT 0,5ml ofO.OlM NaOH | Complies |
Related substance | Impurity A: 0.5% max | 0.04% |
Any other unspecified impurity: 0.3% max | Not Detected | |
Total impurities: 1.0% max | 0.04% | |
Loss on drying | 0.5% max | 0.2% |
Sulphated ash | 0.1% max | 0.04% |
Assay(Dried substance) | 99.0^101.0% | 100.8% |
Residual solvent | Ethanol: 0.5% (5000ppm) max | 0.03% |
Toluene: 0.089% (890ppm) max | 0.0004% |
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