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Oxymetazoline Hydrochloride


Product Description


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

Specifications

GradesUSPBP/EP
Description 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 IR
IR 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 IR
IR 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 µg/ml in water)
Absorptivities at 279 nm, calculated on the dried basis, should not differ by more than 3.0 %.
-
c) By Chloride test
A curdy white precipitate should form, which settles in the test tube, indicating the presence of chlorides ions.
c) By Chloride test
A 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 BY7
Acidity/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 B
Ph.Eur. Impurity C
Ph.Eur. Impurity D
Ph.Eur. Impurity E
Any unspecified
Total
-

Not more than 0.1
Not more than 0.10
Not more than 0.10
Not more than 0.10
Not more than 0.10
Not more than 0.10
Not more than 0.5
Loss on drying (% w/w, determined on 1 g at 105oC, for 3 hrs) Not more than 1.0Not more than 1.0
Sulphated 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, µg/g)
Methanol
Acetone
Isopropyl alcohol
Ethyl acetate
Dimethyl sulfoxide
Toluene
Additional solvent
Benzene
-

Not more than 1000
Not more than 1000
Not more than 1000
Not more than 1000
Not more than 1000
Not 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

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