Very soluble in ethanol (95%), freely soluble in water, and practically insoluble in diethyl ether.
Solubility (USP)
Soluble in water, in alcohol, and in chloroform; slightly soluble in ether
Solubility (BP, EP)
Very soluble in water and in ethanol (96%), freely soluble in methylene chloride
Identification 1 : (JP)
Develops a red color.
Identification A : (BP, EP)
158-164°C (after drying at 105°C for 4 h)
Identification A : (USP)
A white precipitate which is insoluble in 2N nitric acid but soluble in 6N ammonium hydroxide, is formed
Identification 2 : (JP)
The chloroform layer turns colorless.
Identification B, TLC (BP, EP)
The principal spot in the chromatogram obtained with the test solution is similar in position and size to the principal spot in the chromatogram obtained with the reference solution
Identification B, FTIR (USP)
Matches with the standard pattern
Identification 3, UV (JP)
Both spectra exhibit similar intensities of absorption at the same wavelengths.
Identification C (BP, EP)
A blue colour develops in the lower layer
Identification C (USP)
The retention time of the major peak of the sample solution corresponds to the standard solution, as obtained in the assay
Identification 4 (JP)
A white precipitate is produced. This precipitate does not dissolve on addition of dilute nitric acid, but dissolves on addition of ammonia TS.
Identification D : chlorides (BP, EP)
The solution gives reaction (a) of chlorides
Melting point (JP)
158-164°C (after drying)
Appearance of solution (BP, EP)
Solution S (10% solution)is clear and not more intensely coloured than reference solution Y6
Ammonium (JP)
The evolving gas dose not change moistened red litmus paper to blue.
Loss on drying (at 105°C, 4h) : (JP, BP, EP, USP)
<= 5.00%
Residue on ignition (JP, USP)
<= 0.10%
Acidity or alkalinity (BP, EP)
Complies
Volatile bases and salts of volatile bases (EP, BP)
<= 0.0050%
Sulfated ash (BP, EP)
<= 0.10%
Residue on ignition (USP)
<= 0.10%
Organic impurities, system suitability, HPLC : RSD (USP)
<= 5.0%
Organic impurities, HPLC : total impurities (USP)
<= 1.0%
Assay, system suitability, HPLC : Resolution (USP)
>= 7.0 between the benzethonium and methylbenzethonium peak