交联聚维酮-USP35.pdf

Accessed from 128.83.63.20 by nEwp0rt1 on Tue Nov 29 21:22:37 EST 2011 NF 30 Official Monographs / Crospovidone 1775 F = factor converting glycolic acid to sodium and yeasts count does not exceed 100 cfu/g. It meets the glycolate, 12.9 requirements of the tests for absence of Escherichia coli. W1 = weight of glycolic acid in the specimen (mg), • PH 〈791〉: The pH of the dispersion is 5.0–7.0. Mix 1 g with determined from the standard curve and the 100 mL of water for 5 min. absorbance of the Sample solution • SETTLING VOLUME b = percentage of Loss on Drying, determined Analysis: To 75 mL of water in a 100-mL graduated separately cylinder, add 1.5 g of it in 0.5-g portions, shaking W2 = weight of the specimen taken (g) vigorously after each addition. Add water to make 100 mL, Acceptance criteria: The sum of the percentages of shake again until all of the powder is homogeneously sodium chloride and sodium glycolate is NMT 0.5%. distributed, and allow to stand for 4 h. Note the volume of the settled mass. SPECIFIC TESTS Acceptance criteria: The volume of the settled mass is • CONTENT OF WATER-SOLUBLE MATERIAL 10.0–30.0 mL Analysis: Disp