Tetrahydrozoline Hydrochloride
(tet'' ra hye droz' oh leen hye'' droe klor' ide).
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. [noteCover the thin-layer chromatographic plate with a glass plate to slow fading of the spots. ]
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
Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 4819
|