MemantineHydrochlorideTablets（盐酸美金刚片）USP39.pdf

Accessed from 10.6.1.1 by ebsc0sa on Wed Jul 13 23:50:04 EDT 2016 First Supplement to USP 39–NF 34 Official Monographs / Memantine 8087 Table 1 Chromatograph the Identification solution, and identify Time Solution A Solution B the components on the basis of their relative retention (min) (%) (%) times, given in Table 2. Calculate the percentage of each impurity in the por- 0 30 70 tion of Lufenuron taken: 5 30 70 15 10 90 Result = (r /r ) × ( C /C ) × (1/F) × 100 U S S U 17 10 90 rU = peak response of each impurity from the Diluent: Acetonitrile and water (70:30) Sample solution System suitability solution: 0.4 mg/mL of USP rS = peak response of lufenuron from the Diluted Lufenuron RS and 0.14 mg/mL of USP Lufenuron Re- standard solution lated Compound G RS in Diluent. Sonicate if necessary CS = concen