氢氯噻嗪盐酸普萘洛尔缓释胶囊USP标准.docVIP

Propranolol Hydrochloride and Hydrochlorothiazide Extended-Release Capsules ? Propranolol Hydrochloride and Hydrochlorothiazide Extended-Release Capsules contain not less than 90.0 percent and not more than 110.0 percent of the labeled amounts of propranolol hydrochloride (C16H21NO2·HCl) and hydrochlorothiazide (C7H8ClN3O4S2). Packaging and storage— Preserve in well-closed containers. USP Reference standards 11— USP Benzothiadiazine Related Compound A RS . USP Hydrochlorothiazide RS. USP Propranolol Hydrochloride RS. Identification— A: Transfer the contents of a number of Capsules, equivalent to about 100 mg of hydrochlorothiazide, to a 20-mesh sieve. Break up any large lumps with the aid of a spatula, and collect the powder that passes through the sieve. [note—Retain the material on the screen for Identification test B.] Transfer the powder that passed through the sieve to a screw-capped, 35-mL centrifuge tube, add 5 mL of solvent hexane, and shake for 5 minutes. Centrifuge, and discard the solvent. To the residue in the centrifuge tube add 10 mL of 1 N sodium hydroxide, shake, and filter, collecting the filtrate in a separator. Wash the filter with 5 mL of water, and collect the washing in the separator. Add 50 mL of ether to the separator, shake for 2 minutes, and allow the phases to separate. Drain the aqueous layer into a beaker, adjust with 6 N hydrochloric acid to a pH of about 2, induce crystallization by scratching the inner surface of the beaker with a glass rod, and allow to stand until crystallization is complete. Collect the crystals on a filter, and dry at 105 for 30 minutes. Grind the crystals to a fine powder: the IR absorption spectrum of a mineral oil dispersion of the powder so obtained exhibits maxima only at the same wavelengths as that of a similar preparation of USP Hydrochlorothiazide RS. B: Wash the material retained on the screen from Identification test A with a small amount of water, discarding the washings. Transfer the particles