58-73-1 Diphenhydramine 2-benzhydryloxyethyldimethylamine
ITEMS |
STANDARDS |
RESULTS |
Characteristics |
White or almost white,crystalline powder |
A white crystalline powder |
Identification |
A. IR: Comport with the reference; B. The retention time comport to the reference C. The Chloride Reaction |
Complies Complies
Complies |
Acidity or alkalinity |
≤0.5ml of 0.01M NaOH |
0.47ml |
Loss on drying |
≤0.5% |
0.15% |
Residue on ignition |
≤0.1% |
0.08% |
Related substance |
Impurity A≤0.5% Impurity B≤0.3% Impurity C≤0.3% Impurity D≤0.3% Impurity E≤0.3% Any other unspecified impurity≤0.1% Total≤1.0% |
0.05% N.D. N.D. 0.03% N.D. N.D. 0.08% |
Residue solvent |
Toluene≤890ppm Ethanol≤5000ppm |
12.5ppm 207.0ppm |
Assay |
98.0~102.0%(dried) |
99.57% |
Conclusion |
The above product conforms to First Supplement to USP36. |
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