文件由newp0rt1于东部时间2011年11月26日星期六.pdfVIP

Accessed from 128.83.63.20 by nEwp0rt1 on Sat Nov 26 23:43:55 EST 2011 USP 35 Official Monographs / Oxycodone 4173 Dissolution 711— ASSAY Medium: water; 500 mL. • PROCEDURE Apparatus 2: 50 rpm. Buffer solution: 2 g/L of sodium heptanesulfonate in water. Add 13.3 mL/L of glacial acetic acid, and adjust with 5 N Time: 45 minutes. sodium hydroxide solution to a pH of 3.50 ± 0.05. Procedure—Determ he amount of C H NO · HCl dis- 18 21 4 phase: Acetonitrile and Buffer solution (1:3) solved by employing UV absorption at about 225 nm on Standard solution: 0.036 mg/mL of USP Oxycodone RS in filtered portions of the solution under test, suitably diluted with phase Dissolution Medium, if necessary, omparison with a Standard Sample stock solution: Transfer 10 Tablets into an appropri- solution having a known concentration of USP Oxycodone RS in ate volumetric flask, add a volume of a mixture of methanol 0.1 N hydrochloric acid. and acetonitrile (1:1), equivalent to 50% of the volumetric Tolerances—Not less than 70% (Q) of the labeled amount of flask volume, sonicate for 10 min, and stir for 20 min. Dilute C H NO · HCl is dissolved in 45 minutes.