Tetrahydrozoline Hydrochloride Click to View Image C13H16N2·HCl 236.74
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. USP Reference standards á11ñ USP Tetrahydrozoline Hydrochloride RS. Identification— A: Infrared Absorption á197Kñ. B: Ultraviolet Absorption á197UñSolution: 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 105for 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