Anish Chemicals

Chitra GIDC, Bhavnagar, Gujarat

We supply Oxymetazoline Hydrochloride that is made by the experts by using approved Pharmaceutical materials that are imported from the reliable vendors of the industry. The Oxymetazoline Hydrochloride, we formulate is demanded for its purity and accurate composition. Molecular Formula : C16H24N2O.HCl Molecular Weight : 296.84 SpecificationsGradesUSPBP/EPDescription A white to practically white, fine crystalline powder. Is hygroscopic.A white or almost white crystalline powder.SolubilitySoluble in water, in alcohol, practically insoluble in benzene, in chloroform and in ether.Freely soluble in water and in ethanol (96%).Melting PointShould melts at about 300oC with decomposition.-Identificationa) By IRIR 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.a) By IRIR spectrum of sample recorded as KBr should exhibit transmission minima (absorption maxima) at the same wavelengths to those in the spectrum obtained with the Oxymetazoline hydrochloride working standard.b) By UV (100 g/ml in water)Absorptivities at 279 nm, calculated on the dried basis, should not differ by more than 3.0 %.-c) By Chloride testA curdy white precipitate should form, which settles in the test tube, indicating the presence of chlorides ions.c) By Chloride testA curdy white precipitate should form, which settles in the test tube, indicating the presence of chlorides ions.pH (5 % w/v solution in water)Between 4.0 and 6.5-Appearance of solution (5 % w/v solution in water)-Solution S should be clear and not more intensely coloured than reference solution BY7Acidity/Alkalinity-Not more than 0.4 ml of 0.01 M of sodium hydroxide require to change the colour of the indicator to yellow. Related Substances (% w/w, by HPLC)Ph.Eur. Impurity A Ph.Eur. Impurity BPh.Eur. Impurity CPh.Eur. Impurity DPh.Eur. Impurity EAny unspecifiedTotal -
Not more than 0.1Not more than 0.10Not more than 0.10Not more than 0.10Not more than 0.10Not more than 0.10Not more than 0.5Loss on drying (% w/w, determined on 1 g at 105oC, for 3 hrs) Not more than 1.0Not more than 1.0Sulphated ash (% w/w, determined on 1.0g)-Not more than 0.1 Residue on Ignition (%w/w, determined on 1 g)Not more than 0.1-Heavy metals (%w/w)Not more than 0.001-Assay (% w/ w, By Titrimetry, as C16H24N2O.HCl on dried basis)-Not less than 99.0 and Not more than 101.0 Assay (% w/w, by HPLC as C16H24N2O.HCl on dried basis)Not less than 98.5 and Not more than 101.5 -Residual solvent (by GC, g/g)MethanolAcetoneIsopropyl alcoholEthyl acetateDimethyl sulfoxideTolueneAdditional solventBenzene-
Not more than 1000Not more than 1000Not more than 1000Not more than 1000Not more than 1000Not more than 500
Not more than 2 For BP/EP

• Impurity A = N-(2-aminoethyl)-2-[4-(1, 1-dimethylethyl)-3-hydroxy-2, 6-dimethylphenyl] acetamide
• Impurity B = Xylometazoline or (2-[4-(1, 1-dimethylethyl)-2, 6-dimethylbenzyl]-4, 5-dihydro-1H-imidazole)
• Impurity C=2- [4-(1, 1-dimethylethyl)-3-hydroxy-2, 6-dimethylphenyl] acetamide
• Impurity D = [4-(1, 1-dimethylethyl)-3-hydroxy-2, 6-dimethylphenyl] acetic acid
• Impurity E = [4-(1, 1-dimethylethyl)-3-hydroxy-2, 6-dimethylphenyl] acetonitrile