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Naphazoline Hydrochloride
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C14H14N2·HCl 246.74

1H-Imidazole, 4,5-dihydro-2-(1-naphthalenylmethyl)-, monohydrochloride.
2-(1-Naphthylmethyl)-2-imidazoline monohydrochloride [550-99-2].
» Naphazoline Hydrochloride contains not less than 98.0 percent and not more than 100.5 percent of C14H14N2·HCl, calculated on the dried basis.
Packaging and storage— Preserve in tight, light-resistant containers.
Identification—
Solution: 20 µg per mL.
Medium: methanol.
Absorptivities at 280 nm, calculated on the dried basis, do not differ by more than 3.0%.
C: A solution (1 in 100) responds to the tests for Chloride 191.
pH 791: between 5.0 and 6.6, in a 1 in 100 solution in carbon dioxide-free water, and the solution is clear and colorless.
Loss on drying 731 Dry it at 105 for 2 hours: it loses not more than 0.5% of its weight.
Residue on ignition 281: not more than 0.2%.
Ordinary impurities 466
Test solution: methanol.
Standard solution: methanol.
Eluant: a mixture of methanol, glacial acetic acid, and water (8:1:1).
Visualization: 2.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay— Dissolve about 300 mg of Naphazoline Hydrochloride, accurately weighed, in 50 mL of glacial acetic acid, and add 10 mL of mercuric acetate TS and 1 drop of crystal violet TS. Titrate (see Titrimetry 541) with 0.1 N perchloric acid VS to a blue-green endpoint. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 24.67 mg of C14H14N2·HCl.
Auxiliary Information— Staff Liaison : Feiwen Mao, M.S., Senior Scientific Associate
Expert Committee : (MDOOD05) Monograph Development-Ophthalmics Oncologics and Dermatologicals
USP29–NF24 Page 1480
Pharmacopeial Forum : Volume No. 31(4) Page 1093
Phone Number : 1-301-816-8320