醋酸纤维素美国药典标准.docxVIP

▲Cellulose Acetate Cellulose acetate. Cellulose,diacetate [9035-69-2]. Cellulose,triacetate [9012-09-3]. ?Cellulose Acetate is partially or completely acetylated cellulose」t contains not less than 29.0percent and not more than 44.8percent,by weight,of acetyl (C2H3O)groups,calculated on the dried basis」ts acetyl content is not less than 90.0percent and not more than 110?0percent of that indicated on the label. 醋酸纤维素是部分或全部乙酰化的纤维素。按干燥品计含乙酰基 29.0%?44.8%,乙酰基含量应为标示量的90.0%?110.0%。 Packaging and storage— Preserve in tight containers. 包装与储存密闭储存 Labeling— The labeling states the nominal percentage content of acetyl. 标签一一注明乙酰基的标示含量 USP Reference standards〈11〉一 USP Cellulose /Ace朽fe RS. Identification— Prepare a solution of Cellulose Acetate (1in 10),previously dried,in dioxane.Spread 1drop of the solution on a sodium chloride plate,place a second sodium chloride plate over it,and spread the specimen between the plates.Separate the plates, heat them both at 105Qfor 1 hour,a nd reassemble the dried plates:the IR absorption spectrum exhibits maxima only at the same wave I e ngths as that of a similar preparati on of USP Cellulose Acetate ffS,treated in the same manner. 鉴别一一 Loss on drvina〈731〉— Dry it at 105Qfor 3hours:it loses not more than 5.0%of its weight? 干燥失重一一在105°C干燥3小时减失重量不得过5.0%, Residue on iqnition〈281〉: not more than 0.1%.炽灼残渣 Heavv metals,/Vtef/?od //〈231〉: 0.001%.重金屈 10ppm Free acid— Transfer about 5g,accurately weighed,to a 250-mLflask.Add 150mLof freshly boiled,cooled water,insert the stopper into the flask,swirl the suspension gently,and allow it to stand for 3hours.Filter through paper,and wash the flask and the filter with water,adding these washings to the filtrate.Add phe no Iphthalei n TS,and titrate the combi ned filtrate and was hi ngs with 0.01N sodium hydroxide VS.Calculate the percentage of free acid in the portion of Cellulose Acetate taken by the formula: 0.06005/l/W, in which A is the volume,in mL,of 0.01 Nsodium hydroxide consumed;andl/l/is the wei