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Tetrahydrozoline Hydrochloride
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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 98.0 percent and not more than 100.5 percent of C13H16N2·HCl, calculated on the dried basis.
Packaging and storage— Preserve in tight containers.
Identification—
Solution: 250 µg per mL.
Medium: water.
Absorptivities at 264 nm and 271 nm, calculated on the dried basis, do not differ by more than 4.0%.
C: A solution (1 in 200) responds to the tests for Chloride 191.
Loss on drying 731— Dry it at 105 for 2 hours: it loses not more than 1.0% of its weight.
Residue on ignition 281: not more than 0.1%.
Heavy metals 231— Dissolve 0.40 g in 23 mL of water, and add 2 mL of 1 N acetic acid: the limit is 0.005%.
Ordinary impurities 466—
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.]
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay— Transfer about 400 mg of Tetrahydrozoline Hydrochloride, accurately weighed, to a 250-mL beaker, and dissolve in 60 mL of glacial acetic acid, heating if necessary. Add 5 mL of acetic anhydride, 5 mL of mercuric acetate TS, and 3 drops of quinaldine red TS, and titrate with 0.1 N perchloric acid VS. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 23.67 mg of C13H16N2·HCl.
Auxiliary Information— Staff Liaison : Feiwen Mao, M.S., Senior Scientific Associate
Expert Committee : (MDOOD05) Monograph Development-Ophthalmics Oncologics and Dermatologicals
USP29–NF24 Page 2105
Phone Number : 1-301-816-8320