Oxymetazoline Hydrochloride Pharma Grade

Grade

                BP

                      EP

               USP

Description

White or almost white, crystalline powder.

white or almost white, crystalline powder

A white to practically off white, fine crystalline powder. Is hygroscopic.

Solubility

Freely soluble in water and in ethanol

freely soluble in water and in ethanol (96 per cent)

Soluble in water, in alcohol, practically insoluble in benzene, in chloroform and in ether.

Melting Point

Should melts at about 300C with decomposition.

Identification

a) By IR

IR spectrum of sample recorded as Nujol mull should exhibit transmission minima (absorption maxima) at the same wavelengths to those in the spectrum obtained with the Oxymetazoline hydrochloride-working standard.

b) By Assay (HPLC)

The retention time of the major peak of the sample solution should correspond to that of the standard solution, as obtained in the assay.

c) By Chloride test

A curdy white precipitate should form, which settles in the test tube, indicating the presence of chlorides ions.

Appearance of Solution

The solution is clear and not more intensely colored than reference solution BY7

The solution is clear and not more intensely colored than reference solution BY7

pH (5 % w/v solution in water)

Between 4.0 and 6.5

Acidity /Alkalinity

Not more than 0.4 mL of0.01 M sodium hydroxide

Not more than 0.4 mL of 0.01 M sodium hydroxide

Water

maximum 0.3 %

Loss on drying (% w/w, determined on 1 g at 105⁰C, for 3 hrs)

maximum 1.0 per cent,

Not more than 1.0

Sulphated Ash

Maximum0.1 percent

maximum 0.1 per cent

Residue on Ignition (%w/w, determined on 1 g)

Not more than 0.1

Assay (% w/w, by HPLC as C₁₆H₂₄N₂O.HCl on dried basis)

99.0 per cent to 101.0 per cent

99.0 per cent to 101.0 per cent

Not less than 98.5 and Not more than 101.5

Residual Solvent (by GC, g/g)

Methanol

Acetone

Isopropyl alcohol

Ethyl acetate

Dimethyl sulfoxide

Toluene

Additional Solvent

Benzene

Not more than 1000

Not more than 1000

Not more than 1000

Not more than 1000

Not more than 1000

Not more than 500

Not more than 2

Organic impurities (w/w)

Related compound A

Any individual impurity

Total impurities

0.15

0.10

0.50