With an aim to cater the diverse range of needs of clients, we are presenting our clients pure Oxymetazoline HCl. The offered chemical is globally used for treating nasal congestion and pregnancy problems and is highly demanded in pharmaceutical industry. It is processed under the stern guidance of our experts utilizing optimum grade chemical substances. Further, Oxymetazoline HCl is made available for our prestigious clients at industry leading prices.
Features:
Purity
Accurate composition
Precise pH value
Long shelf life
Specifications:
Grades | USP | BP/EP |
Description | A white to practically white, fine crystalline powder. Is hygroscopic. | A white or almost white crystalline powder. |
Solubility | Soluble in water, in alcohol, practically insoluble in benzene, in chloroform and in ether. | Freely soluble in water and in ethanol (96%). |
Melting Point | Should melts at about 300oC with decomposition. | - |
Identification | a) 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 0.10 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 1.0 | Not 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, g/g) Methanol Acetone Isopropyl alcohol Ethyl acetate Dimethyl sulfoxide Toluene Additional solventBenzene | - | 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