Xylometazoline Hydrochloride

                                           Grade

IP

BP

EP

USP

Description

 A white or almost white crystalline powder.

White to off-white, odourless crystalline powder

White to off-white, odourless crystalline powder

A White to off white, odourless crystalline powder.

Solubility

Freely soluble in ethanol (95%), soluble in water and in chloroform, practically insoluble in ether

Soluble in water, freely soluble in alcohol, Sparingly soluble in chloroform, practically insoluble in benzene and in ether

Soluble in water, freely soluble in alcohol, Sparingly soluble in chloroform, practically insoluble in benzene and in ether

Soluble in water, Freely soluble in alcohol, Sparingly soluble in chloroform and Practically insoluble in benzene and ether.

Melting Point

-

-

-

Should be melts at 300⁰C with decomposition.

Identification

a)  By IR Spectrophotometry

IR spectrum of test sample is concordant with IR spectrum of Xylometazoline WS.

IR Spectrum of test sample is concordant with IR Spectrum of Xylometazoline Hydrochloride WS.

IR Spectrum of test sample is concordant with IR Spectrum of Xylometazoline Hydrochloride WS.

IR spectrum of sample recorded as Nujol oil should exhibit maxima and minima at the same wavelengths as that of the similar preparation of IR spectra of Xylometazoline Hydrochloride working standard.

B: By UV

An absorbance A 0.05% soln in 0.1 M HCl shows an absorption maximum at about 265 nm & a minimum at about 257 nm with two inflections at about 270 nm & 275 nm, absorbance at about 265 nm, about 0.5

d) by UV

The solution shows no fluorescence or at most the same fluorescence as a blank solution prepared in the same manner. The identification is not valid unless a solution prepared in the same manner using naphazoline hydrochloride CRS instead of the substance to be examined shows a distinct bluish fluorescence when examined under UV light at 365 nm.

d) by UV

The solution shows no fluorescence or at most the same fluorescence as a blank solution prepared in the same manner. The identification is not valid unless a solution prepared in the same manner using naphazoline hydrochloride CRS instead of the substance to be examined shows a distinct bluish fluorescence when examined under UV light at 365 nm.

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c) By chemical test

A violet colour develops.

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d) Test for Chloride

Gives reaction of chlorides

It gives reactions of Chloride salts

It gives reactions of Chloride salts

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e) By TLC

-

The principle spot obtained in test solution is similar in position, colour and size to the principle spot in the chromatogram obtained with Xylometazoline Hydrochloride WS.

The principle spot obtained in test solution is similar in position, colour and size to the principle spot in the chromatogram obtained with Xylometazoline Hydrochloride WS.

The Rf value of the principle spot in the chromatogram of the identification preparation should be corresponds to that of standard preparation A as obtained in the test for chromatographic purity

pH

(5.0 % w/v solution in water)

5.0 to 6.6

Between 5.0 to 6.6

Acidity/Alkalinity

-

Not more than 0.2 ml 0.01 M NaOH is required to change the colour of the indicator to yellow

Not more than 0.2 ml 0.01 M NaOH is required to change the colour of the indicator to yellow

-

Appearance of solution

-

The solution is clear & not more intensely coloured then reference solution Y₆

The solution is clear & not more intensely coloured then reference solution Y₆

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Related substances by HPLC

Impurity A

Unspecified impurity

Total impurities

Not more than 0.2 %

Not more than 0.1 %

Not more than 0.5 %

Not more than 0.2 %

Not more than 0.1 %

Not more than 0.5 %

Not more than 0.2

Not more than 0.1

Not more than 0.5

Iron (ppm)

Max. 50 ppm

-

-

-

Sulphates (ppm)

Max. 200 ppm

-

-

-

Sulphated ash

Not more than 0.1%

Not more than 0.1 %

Not more than 0.1 %

Loss on drying

Not more than 0.5%

Not more than 0.5 %

Not more than 0.5 %

Not more than 0.5

Residual on  ignition

-

-

-

Not more than 0.1

Chromatographic purity by TLC.

-

-

-

The sum of the intensities of all secondary spots obtained from the test solution corresponds to not more than 1.0 %.

Assay by Potentiometer

Between 99.0 and 101.0% calculated on dried basis

by Potentiometer)

Between 99.0 % and 101.0 %

by Potentiometer)

Between 99.0 % and 101.0 %

Not less than 98.0 and Not more than 102.0

Residual Solvents

(by GC, g/g)

Methanol

Acetone

Isopropyl alcohol

Tert butyl alcohol

Ethyl acetate

Benzene

Methyl iso butyl ketone

Toluene

m-Xylene

        -

Not more than 3000

Not more than 3000

Not more than 3000

Not more than 3000

Not more than 3000

Not more than 2

Not more than 500

Not more than 890

Not more than 500

Not more than 3000

Not more than 3000

Not more than 3000

Not more than 3000

Not more than 3000

Not more than 2

Not more than 500

Not more than 890

Not more than 500

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