Usp - cloridrato de verapamil - monografia da droga

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C27H38N2O4·HCl

491.06

Benzeneacetonitrile, -[3-[[2-(3,4-dimethoxyphenyl)ethyl]methylamino]propyl]-3,4-dimethoxy- -(1methylethyl)-, monohydrochloride, (±)-. (±)-5-[(3,4-Dimethoxyphenethyl)methylamino]-2-(3,4-dimethoxyphenyl)-2-isopropylvaleronitrile monohydrochloride [152-11-4].

» Verapamil Hydrochloride contains not less than 99.0 percent and not more than 100.5 percent of C27H38N2O4·HCl, calculated on the dried basis.
Packaging and storage— Preserve in tight, light-resistant containers. Store at 25 , excursions permitted between 15 and 30 . USP Reference standards B RS. Identification— A: Infrared Absorption 197K . 11 — USP Verapamil Hydrochloride RS. USP Verapamil Related Compound

B: The retention time of the major peak for verapamil in the chromatogram of the Test preparation corresponds to that exhibited in the chromatogram of Standard preparation B, as obtained in the test for Chromatographic purity. C: It responds to the tests for Chloride Melting range pH 191 .

741 : between 140 and 144 .

791 : between 4.5 and 6.5, in a solution, prepared with gentle heating, containing 50 mg per mL. 731 — Dry it at 105 for 2 hours: it loses not more than 0.5% of its weight. 281 : not more than 0.1%.

Loss on drying

Residue on ignition

Chromatographic purity— Aqueous solvent mixture— Prepare a 0.015 N sodium acetate solution containing about 33 mL of glacial acetic acid per L. Mobile phase— Prepare a filtered and degassed mixture of Aqueous solvent mixture, acetonitrile, and 2aminoheptane (70:30:0.5). Make adjustments if necessary (see System Suitability under Chromatography 621 ).