Our firm is betrothed in offering supreme quality Xylometazoline HCl to our esteemed clients. It helps to decrease nasal congestion and is demanded in pharmaceutical industry to make medicines for treatment of high blood pressure. This chemical is formulated at our well equipped formulating unit under the stern guidance our dexterous professionals. The offered Xylometazoline HCl is available in a variety of packaging options to meet the diverse needs of our clients. This extract is strictly tested by our team of quality analysts prior to dispatch from our end.
Features:
High effectiveness
Longer shelf life
Purity
Accurate composition
Specifications:
Grades | IP | BP/EP | USP |
Description | A White or almost white, crystalline powder; odorless or almost odorless. | White to off-white, odorless crystalline powder | White to off-white, odorless crystalline powder |
Solubility | Freely soluble in Water, in alcohol and in methanol. 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 |
Identification | 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. | a) By IR IR Spectrum of test sample is concordant with IR Spectrum of Xylometazoline Hydrochloride WS. | a) By IR IR Spectrum of test sample is concordant with IR Spectrum of Xylometazoline Hydrochloride WS. |
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 | 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. | 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. | |
c) By chemical test A violet color should produce. | c) Melting Point Melts at 300oC with decomposition | c) Melting Point Melts above 300oC with decomposition | |
d) Test for Chloride A curdy white precipitate should form, which settles in the test tube, indicating presence of chloride ions. | - | - | |
pH (5.0 % w/v solution in water) | Between 5.0 to 6.6 | - | Between 5.0 & 6.6 |
Appearance of solution (5.0% in water) | | 5.0 % solution in water is clear | |
Acidity/Alkalinity | | Not more than 0.2 ml 0.01 M NaOH is required. | |
N-(2-Aminoethyl)-4-tert butyl-2,6-xylylacetamide by TLC | 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%) | - | |
Related substances (%, by HPLC) Xylometazoline impurity A Any other impurity Total impurities | (%, by HPLC) Not more than 0.2 Not more than 0.1 Not more than 0.5 | (by TLC) Not more than 0.2 % Not more than 0.2 % | |
Iron (ppm) | Not more than 50 | - | |
Sulphates (ppm) | Not more than 200 | - | |
Sulphated ash (%w/w, determined on 1g) | Not more than 0.1 | Not more than 0.1 % | |
Residue on Ignition | - | - | Not more than 0.1 % |
Chromatographic Purity | - | - | Complies with standard |
Loss on drying (%w/w, determined on 1g at 105oC, for 4 hr.) | Not more than 0.5 | Not more than 0.5 % | Not more than 0.5 % |
Assay (%w/w C16H24N2HCl , on dried basis) | (by Titrimetry) Not less than 99.0 and Not more than 101.0 | (by Potentiometer) Between 99.0 % and 101.0 % | (by Potentiometer) Between 99.0 % and 101.0 % |
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 2 Not more than 500 Not more than 890 Not more than 500 | | |
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