FCCV-阿斯巴甜.docVIP

DESCRIPTION Aspartame occurs as a white, crystalline powder. It is sparingly soluble in water and slightly soluble in alcohol. The pH of a 0.8% solution is between about 4.5 and 6.0. Function Sweetener; sugar substitute; flavor enhancer. REQUIREMENTS Identification The infrared absorption spectrum of a potassium bromide dispersion of sample exhibits maxima only at the same wavelengths as those of a similar preparation of USP Aspartame Reference Standard. Assay Not less than 98.0% and not more than 102.0% of C14H18N2O5, calculated on the dried basis. 5-Benzyl-3,6-dioxo-2-piperazineacetic Acid Not more than 1.5%. Lead Not more than 1 mg/kg. Loss on Drying Not more than 4.5%. Optical (Specific) Rotation [_]D 20°: Between +14.5° and +16.5°, calculated on the dried basis. Other Related Substances Not more than 2.0%. Residue on Ignition Not more than 0.2%. TESTS Assay Transfer about 300 mg of sample, accurately weighed, to a 150-mL beaker, dissolve in 1.5 mL of 96% formic acid, and add 60 mL of glacial acetic acid. Add crystal violet TS, and titrate immediately with 0.1 N perchloric acid to a green endpoint. Caution: Handle perchloric acid in an appropriate fume hood. Note: Use 0.1 N perchloric acid previously standardized to a green endpoint. A blank titration exceeding 0.1 mL may be due to excessive water content and may cause loss of visual endpoint sensitivity. Perform a blank determination (see General Provisions), and make any necessary correction. Each milliliter of 0.1 N perchloric acid is equivalent to 29.43 mg of C14H18N2O5. 5-Benzyl-3,6-dioxo-2-piperazineacetic Acid Mobile Phase Weigh and transfer 5.6 g of potassium phosphate monobasic into a 1-L flask, add 820 mL of water, and dissolve. Adjust the pH to 4.3 using phosphoric acid, add 180 mL of methanol, and mix. Filter through a 0.45-_m disk, and de-gas. Diluting Solvent Add 200 mL of methanol to 1800 mL of water, and mix. Impurity Standard Preparation Transfer about 25 mg of USP 5-Benzyl-3,6-dioxo-2-piperazi