Xylometazoline Hydrochloride

IP

BP/EP

USP NF

Description

White or almost white crystalline powder

White or almost white crystalline powder

White to off white, odourless crystalline powder

Identification

-  

By UV

Appearance of Solution

-

Clear and not more intensely collared than reference solution Y6

-

Solubility

Freely soluble in water, in ethanol (96%) and in methanol

Freely soluble in water, in ethanol (96%) and in methanol

Soluble in water; freely soluble in alcohol; sparingly soluble in chloroform; practically insoluble in benzene and in ether

pH

5.0 to 6.6

-

5.0 to 6.6

Acidity/Alkalinity

-

Not more than 0.2 mL of 0.01 NaOH is required to change color of the indicator to yellow

-

Related Substances/Impurities (% by HPCL) Xylometazoline Impurity A Any other impurity Total impurities

-

Not more than 0.2%
Not more than 0.2%
Not more than 0.5%

Not more than 0.2%
Not more than 0.10%
Not more than 0.5%

Residue on Ignition

-

-

Max 0.1%

Iron

50 ppm

-

-

Heavy Metals 

-

-

-

Sulphated ash

Max 0.1%

Max 0.1%

-

Sulphates

200 ppm

-

-

Loss on drying

Max 0.5%

Max 0.5%

Max 0.5%

Assay on dried basis

99.0 % to 101.0%

99.0 % to 101.0%

98.0% to 102.0%