Naphazoline Hydrochloride
;)
1H-Imidazole,4,5-dihydro-2-(1-naphthalenylmethyl)-,monohydrochloride.
2-(1-Naphthylmethyl)-2-imidazoline monohydrochloride [550-99-2].
»Naphazoline Hydrochloride contains not less than 98.0percent and not more than 100.5percent of C14H14N2·HCl,calculated on the dried basis.
Packaging and storage—
Preserve in tight,light-resistant containers.
Identification—
A:
Infrared Absorption á197Kñ.
Solution:
20µg per mL.
Medium:
methanol.
Absorptivities at 280nm,calculated on the dried basis,do not differ by more than 3.0%.
C:
Asolution (1in 100)responds to the tests for Chloride á191ñ.
pHá791ñ:
between 5.0and 6.6,in a 1in 100solution in carbon dioxide-free water,and the solution is clear and colorless.
Loss on drying á731ñ—
Dry it at 105
for 2hours:it loses not more than 0.5%of its weight.
for 2hours:it loses not more than 0.5%of its weight.
Residue on ignition á281ñ:
not more than 0.2%.
Ordinary impurities á466ñ—
Test solution:
methanol.
Standard solution:
methanol.
Eluant:
a mixture of methanol,glacial acetic acid,and water (8:1:1).
Visualization:
2.
Assay—
Dissolve about 300mg of Naphazoline Hydrochloride,accurately weighed,in 50mLof glacial acetic acid,and add 10mLof mercuric acetate TSand 1drop of crystal violet TS.Titrate (see Titrimetry á541ñ)with 0.1Nperchloric acid VSto a blue-green endpoint.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 24.67mg of C14H14N2·HCl.
Auxiliary Information—
Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(PA6)Pharmaceutical Analysis 6
USP28–NF23Page 1333
Phone Number:1-301-816-8389