SodiumStearylFumarate.PDF

Accessed from 128.83.63.20 by nEwp0rt1 on Wed Nov 30 03:51:36 EST 2011 1960 Sodium / Official Monographs NF 30 ? PH ?791?: Disperse 1 g in 30 mL of water. The pH of the orate the mixture at about 80° to dryness, and dry at 105° for resulting suspension is either 5.5–7.5 for Type A or 3.0–5.0 4 hours: it loses not more than 5.0% of its weight. for Type B. Alcohol-insoluble substances—Reflux 1.0 g with 25 mL of ? LOSS ON DRYING ?731?: Dry a sample at 130° for 90 min: it alcohol: it dissolves completely, and the resulting solution is loses NMT 10.0% of its weight. clear or not more than slightly opalescent. ADDITIONAL REQUIREMENTS Assay—Proceed with Sodium Stearate as directed in the Assay ? PACKAGING AND STORAGE: Preserve in well-closed containers, under Stearic Acid, using about 100 mg of Sodium Stearate, preferably protected from wide variations in temperature and accurately weighed. Determine the percentage of C18H35NaO2 in humidity, which may cause caking. the portion of Sodium Stearate taken by the formula: ? LABELING: Label it to indicate the botanical source of the starch from which it was derived, the cross-linking agent (if 100(A / B) used), the pH range, and whether it is Type A or Type B. in which A is the area due to the methyl stearate peak, and B is ? USP REFERENCE STANDARDS ?11? USP Sodium Starch Glycolate Type A RS the sum of the areas of all fatty acid ester peaks in the chromat- USP Sodium Starch Glycolate Type B RS ogram. Similarly, determine the percentage of C16H31NaO2. . . Sodium Stearate