Xylometazoline Hcl Ip

We are known for manufacturing, exporting, distributing, trading and supplying Xylometazoline HCL IP to our customers in Bhavnagar, Gujarat, India.

Specifications:
A White or almost white, crystalline powder; odorless or almost odorless
Solubility:Freely soluble in Water, in alcohol and in methanol. insoluble 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.
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
c) By chemical test: A violet color should produce.
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
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: NMT 0.2
Any other impurity: NMT 0.1
Total impurities(%, by HPLC): NMT 0.5
Iron (ppm): Max. 50
Sulphates (ppm): Max. 200
Sulphated ash (%w/w, determined on 1g): Max 0.1