Oxymetazoline Hydrochloride
Phenol,3-[(4,5-dihydro-1H-imidazol-2-yl)methyl]-6-(1,1-dimethylethyl)-2,4-dimethyl-,monohydrochloride. 6-tert-Butyl-3-(2-imidazolin-2-ylmethyl)-2,4-dimethylphenol monohydrochloride [2315-02-8]. »Oxymetazoline Hydrochloride contains not less than 98.5percent and not more than 101.5percent of C16H24N2O·HCl,calculated on the dried basis.
Packaging and storage
Preserve in tight containers.
Identification
A:
Infrared Absorption á197Mñ.
Solution
:100µg per mL.
Medium:
water.
Absorptivities at 279nm,calculated on the dried basis,do not differ by more than 3.0%.
C:
To a solution of about 50mg in 3mLof water add 1mLof 6Nammonium hydroxide,filter,and acidify the filtrate with nitric acid:the filtrate responds to the tests for Chloride á191ñ.
pHá791ñ:
between 4.0and 6.5,in a solution (1in 20).
Loss on drying á731ñ
Dry it at 105for 3hours:it loses not more than 1.0%of its weight.
Residue on ignition á281ñ:
not more than 0.1%.
Heavy metals,Method IIá231ñ:
0.001%.
Assay
Mobile phase
Prepare a suitable degassed solution of water,methanol,1Msodium acetate,and glacial acetic acid (46:40:10:4).
Standard preparation
Prepare a solution in Mobile phaseof USP Oxymetazoline Hydrochloride RShaving a known concentration of about 0.5mg per mL.
Assay preparation
Transfer about 25mg of Oxymetazoline Hydrochloride,accurately weighed,to a 50-mLvolumetric flask,dissolve in Mobile phase,dilute with Mobile phaseto volume,and mix.
Chromatographic system
(see Chromatography á621ñ)The liquid chromatograph is equipped with a 280-nm detector and a 4.6-mm ×0.25-m column that contains packing L9.The flow rate is about 1mLper minute.Chromatograph five replicate injections of the Standard preparation,and record the peak responses as directed for Procedure:the tailing factor is not more than 2.0and the relative standard deviation is not more than 2.0%.
Procedure
Separately inject equal volumes (about 20µL)of the Standard preparationand the Assay preparationinto the chromatograph,record the chromatograms,and measure the response for the major peak.Calculate the quantity,in mg,of C16H24N2O·HCl in the portion of Oxymetazoline Hydrochloride taken by the formula:
50C(rU/rS),
in which Cis the concentration,in mg per mL,of USP Oxymetazoline RSin the Standard preparation,and rUand rSare the peak responses obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information
Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(PA6)Pharmaceutical Analysis 6
USP28NF23Page 1444
Phone Number:1-301-816-8389
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