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
By chloride test

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 0.10%                         
Not more than 0.5%

Not more than  0.1%
Not more than 0.10% Not more than 0.5%

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%