Oxymetazoline Hydrochloride
IP | USP-NF | BP/EP |
|
Description | White or almost white powder | White to practically white, fine crystalline powder | White or almost white crystalline powder. |
Identification | By TLC | ||
Solubility | Freely soluble in water and in ethanol | Soluble in water and in alcohol; practically insoluble in benzene, in chloroform and in ether | Freely soluble in water and in ethanol (96%) |
Melting point | - | Should melts at about 3000C with decomposition | - |
pH (5% w/v solution in water) | 4.5 to 6.5 | Between 4.0 and 6.5 | - |
Appearance of solution (5% w/v solution in water) | - | - | Clear and not more intensely coloured than reference solution BY7 |
Acidity / Alkalinity | - | - | Not more than 0.4 ml of 0.01 M sodium hydroxide require changing the color of the indicator to yellow |
Related substances/ Impurities(% w/w, by HPCL) Impurity A Any unspecified Total | - | Not more than 0.15% | Not more than 0.1% |
Loss on drying (% w/w determined on 1 g at 1050C, for 3 hrs | Note more than 1.0% | Not more than 1.0 % | Not more than 1.0% |
Sulphated ash | Note more than 0.1% | - | Not more than 0.1 % |
Residue on Ignition | - | Not more than 0.1 | - |
Heavy Metals | 10 ppm | Not more than 0.001 | - |
Assay ( % w/w by Titrimetry, as C16H24N2O,HCl on dried basis ) | 98.5% to 101.5% | 98.5% to 101.5% | 99.0% to 101.0% |