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IP
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BP/EP
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USP
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A White or almost white, crystalline powder; odorless or almost odorless.
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White to off-white, odorless crystalline powder
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White to off-white, odorless crystalline powder
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Solubility
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Freely soluble in Water, in alcohol and in methanol. Practically insoluble in ether
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Soluble in water, freely soluble in alcohol, Sparingly soluble in chloroform, practically insoluble in benzene and in ether
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Soluble in water, freely soluble in alcohol, Sparingly soluble in chloroform, practically insoluble in benzene and in ether
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Identification
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a) By IR (KBr)
IR spectrum of sample recorded as KBr should exhibit maxima and minima at the same wavelengths as that of the similar preparation of IR spectra of Xylometazoline Hydrochloride working standard.
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a) By IR
IR Spectrum of test sample is concordant with IR Spectrum of Xylometazoline Hydrochloride WS.
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a) By IR
IR Spectrum of test sample is concordant with IR Spectrum of Xylometazoline Hydrochloride WS.
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b) by UV
An absorbance should be maximum at about 265 nm and minimum at about 257 nm with two inflections at about 270 nm and 275 nm.
Absorbance at about 265 nm, about 0.5
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b) by TLC
The principle spot obtained in test solution is similar in position and size to the principle spot in the chromatogram obtained with Xylometazoline Hydrochloride WS.
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b) By TLC
The size ,intensity and Rf value of principal spot obtained from The test solution correspond to those of the principal spot obtained from the Xylometazoline Hydrochloride WS-solution.
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c) By chemical test
A violet color should produce.
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c) Melting Point
Melts at 300 OC with decomposition
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c) Melting Point
Melts above 300ºC with decomposition
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d) Test for Chloride
A curdy white precipitate should form, which settles in the test tube, indicating presence of chloride ions.
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-
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-
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pH (5.0 % w/v solution in water)
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Between 5.0 to 6.6
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-
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Between 5.0 & 6.6
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Appearance of solution
(5.0% in water)
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5.0 % solution in water is clear
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Acidity/Alkalinity
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Not more than 0.2 ml 0.01 M NaOH is required.
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N-(2-Aminoethyl)-4-tert butyl-2,6-xylylacetamide by TLC
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Any spot corresponding to N-(2-Aminoethyl)-4-tert butyl-2,6-xylylacetamide in the chromatogram obtained with the test solution should not more intense than the spot in the chromatogram obtained with the reference solution (0.5%)
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-
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Related substances
(%, by HPLC)
Xylometazoline impurity A
Any other impurity
Total impurities
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(%, by HPLC)
Not more than 0.2
Not more than 0.1
Not more than 0.5
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(by TLC)
Not more than 0.2 %
Not more than 0.2 %
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Iron (ppm)
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Not more than 50
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-
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Sulphates (ppm)
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Not more than 200
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-
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Sulphated ash (%w/w, determined on 1g)
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Not more than 0.1
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Not more than 0.1 %
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Residue on Ignition
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-
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-
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Not more than 0.1 %
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Chromatographic Purity
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-
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-
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Loss on drying (%w/w, determined on 1g at 105ºC, for 4 hr.)
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Not more than 0.5
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Assay (%w/w C16H24N2HCl , on dried basis)
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(by Titrimetry)
Not less than 99.0 and Not more than 101.0
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(by Potentiometer)
Between 99.0 % and 101.0 %
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(by Potentiometer)
Between 99.0 % and 101.0 %
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Residual Solvents
(by GC, µg/g)
Methanol
Acetone
Isopropyl alcohol
Tert butyl alcohol
Ethyl acetate
Benzene
Methyl iso butyl ketone
Toluene
m-Xylene
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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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