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Lecithin
» Lecithin is a complex mixture of acetone-insoluble phosphatides, which consist chiefly of phosphatidyl choline, phosphatidyl ethanolamine, phosphatidyl serine, and phosphatidyl inositol, combined with various amounts of other substances such as triglycerides, fatty acids, and carbohydrates, as separated from the crude vegetable oil source. It contains not less than 50.0 percent of acetone-insoluble matter.
Packaging and storage— Preserve in well-closed containers.
Acid value 401: If the substance under test is plastic or semisolid, soften the Lecithin by warming it briefly at a temperature not exceeding 60, and then mix. Transfer about 2 g, accurately weighed, to a 250-mL conical flask, and dissolve it in 50 mL of solvent hexane. To this solution add 50 mL of alcohol, previously neutralized to phenolphthalein with 0.1 N sodium hydroxide, and mix. Add phenolphthalein TS, and titrate with 0.1 N sodium hydroxide VS to a pink endpoint that persists for 5 seconds. Calculate the number of mg of potassium hydroxide required to neutralize the free acids in 1.0 g of the specimen by multiplying the number of mL of 0.1 N sodium hydroxide VS consumed in the titration by 5.6 and dividing the result by the weight, in g, of the test specimen: not more than 36 mg of potassium hydroxide are required to neutralize the free acids.
Water, Method I 921: not more than 1.5%.
Hexane-insoluble matter— If the substance under test is plastic or semisolid, soften the Lecithin by warming it at a temperature not exceeding 60, and then mix. Weigh 10.0 g into a 250-mL conical flask, add 100 mL of solvent hexane, and shake until solution is apparently complete or until no more of any residue seems to be dissolving. Filter through a coarse-porosity filtering funnel that previously has been heated at 105 for 1 hour, cooled, and weighed, wash the flask with two 25-mL portions of solvent hexane, and pour both washings through the funnel. Dry the funnel at 105 for 1 hour. [Caution—Hexane is flammable. ] Cool to room temperature, and determine the gain in weight: not more than 0.3% is found.
Lead 251: 0.001%.
Content of acetone-insoluble matter— If the substance under test is plastic or semisolid, soften the Lecithin by warming it briefly at a temperature not exceeding 60, and then mix. Transfer about 2 g to a 40-mL centrifuge tube that previously has been tared with a stirring rod, cool, and weigh accurately. Add 15.0 mL of acetone, warm carefully in a water bath to melt the test specimen without evaporating the acetone, but with stirring to aid complete disintegration, and place in an ice-water bath for 5 minutes. Add acetone that previously has been chilled to 0 to 5 to the 40-mL mark on the tube, stirring during the addition. Cool in an ice-water bath for 15 minutes, stir, remove the rod, clarify by centrifuging at about 2000 rpm for 5 minutes, and decant. Break up the residue with the stirring rod, and refill the centrifuge tube to the 40-mL mark with chilled acetone, while stirring. Cool in an ice-water bath for 15 minutes, stir, remove the rod, centrifuge, and decant. Break up the residue with the stirring rod. Place the tube in a horizontal position until most of the acetone has evaporated, mix again, and heat the tube containing the acetone-insoluble residue and the stirring rod at 105 to constant weight. [Caution—Acetone is flammable. ] Determine the weight of the residue, and calculate the percentage of acetone-insoluble matter.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Auxiliary Information— Staff Liaison : Hong Wang, Ph.D. , Senior Scientific Associate
Expert Committee : (EM205) Excipient Monographs 2
USP29–NF24 Page 3359
Phone Number : 1-301-816-8351