Tetrahydrozoline Hydrochloride
;)
1H-Imidazole,4,5-dihydro-2-(1,2,3,4-tetrahydro-1-naphthalenyl)-,monohydrochloride.
2-(1,2,3,4-Tetrahydro-1-naphthyl)-2-imidazoline monohydrochloride [522-48-5].
»Tetrahydrozoline Hydrochloride contains not less than 98.0percent and not more than 100.5percent of C13H16N2·HCl,calculated on the dried basis.
Packaging and storage—
Preserve in tight containers.
Identification—
A:
Infrared Absorption á197Kñ.
Solution:
250µg per mL.
Medium:
water.
Absorptivities at 264nm and 271nm,calculated on the dried basis,do not differ by more than 4.0%.
C:
Asolution (1in 200)responds to the tests for Chloride á191ñ.
Loss on drying á731ñ—
Dry it at 105
for 2hours:it loses not more than 1.0%of its weight.
for 2hours:it loses not more than 1.0%of its weight.
Residue on ignition á281ñ:
not more than 0.1%.
Heavy metals á231ñ—
Dissolve 0.40g in 23mLof water,and add 2mLof 1Nacetic acid:the limit is 0.005%.
Ordinary impurities á466ñ—
Test solution:
methanol.
Standard solution:
methanol.
Eluant:
a mixture of methanol,glacial acetic acid,and water (8:1:1).
Visualization:
3,followed by overspraying with hydrogen peroxide TS.[NOTE—Cover the thin-layer chromatographic plate with a glass plate to slow fading of the spots.]
Assay—
Transfer about 400mg of Tetrahydrozoline Hydrochloride,accurately weighed,to a 250-mLbeaker,and dissolve in 60mLof glacial acetic acid,heating if necessary.Add 5mLof acetic anhydride,5mLof mercuric acetate TS,and 3drops of quinaldine red TS,and titrate with 0.1Nperchloric acid VS.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 23.67mg of C13H16N2·HCl.
Auxiliary Information—
Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(PA6)Pharmaceutical Analysis 6
USP28–NF23Page 1892
Phone Number:1-301-816-8389