羧甲基淀粉钠美国药典30版标准.docVIP

羧甲基淀粉钠 美国药典30版标准Sodium Starch Glycolate Starch carboxymethyl ether, sodium salt.? Sodium Starch Glycolate is the sodium salt of a carboxymethyl ether ofstarch or of a cross-linked carboxymethyl ether of starch. It may contain notmore than 7.0 percent of Sodium Chloride. The pH and assayrequirements for Type A and Type B are set foHTh in the accompanyingtable。 Packaging and storage— Preserve in well-closed containers, preferably protected from widevariations in temperature and humidity, which may cause caking.Labeling— Label it to indicate the botanical source of the starch from which it was derived, thecross-linking agent (if used), the pH range, and whether it is Type A or Type B.USP Reference standards 11 —USP Sodium Starch Glycolate Type A RS.USP Sodium Starch Glycolate Type B RS.Identification—A: Infrared Absorption 197K .B: A slightly acidified solution of it is colored blue to violet by the addition of iodine andpotassium iodide TS 1.C: To a 2-mL poHTion of the solution prepared for the test for Limit of iron, add 4 mL ofPotassium pyroantimonate solution. If necessary, rub the inside of the test tube with a glassrod. A white, crystalline precipitate is formed.Potassium pyroantimonate solution—To 2 g of potassium pyroantimonate add 100 mL ofwater. Boil the solution for about 5 minutes, cool quickly, and add 10 mL of a solution ofpotassium hydroxide (3 in 20). Allow to stand for 24 hours, and filter.D: Sodium Starch Glycolate impaHTs an intense yellow color to a nonluminous flame.Microbial limits 61 — It meets the requirements of the tests for absence of Salmonellaspecies and Escherichia coli.pH 791 — Disperse 1 g in 30 mL of water. The pH of the resulting suspension is eitherbetween 5.5 and 7.5 for Type A or between 3.0 and 5.0 for Type B.Loss on drying 731 — Dry it at 130 for 90 minutes: it loses not more than 10.0% of itsweight.Heavy metals, Method II 231 : 0.002%.Limit of iron—Standard solution— Dissolve 863.4 mg of ferric ammo