Podophyllum Resin
» Podophyllum Resin is the powdered mixture of resins extracted from Podophyllum by percolation with Alcohol and subsequent precipitation from the concentrated percolate upon addition to acidified water. It contains not less than 40.0 percent and not more than 50.0 percent of hexane-insoluble matter. [Caution—Podophyllum Resin is highly irritating to the eye and to mucous membranes in general. ]
Packaging and storage— Preserve in tight, light-resistant containers.
Identification—
A: It is soluble in 1 N potassium hydroxide or in 1 N sodium hydroxide, forming a yellow liquid, which gradually becomes darker on standing and from which the resin is precipitated by hydrochloric acid.
B: A hot solution of it deposits most of its solids on cooling, and if the cooled liquid is filtered, the filtrate turns brown upon the addition of a few drops of ferric chloride TS.
Residue on ignition 281: not more than 1.5%.
Distinction from resin of Indian podophyllum— Add 400 mg to 3 mL of 60 percent alcohol, then add 0.5 mL of 1 N potassium hydroxide, shake the mixture gently, and allow to stand for 2 hours: it does not gelatinize.
Hexane-insoluble matter— Transfer about 1 g of Podophyllum Resin, accurately weighed, to a glass-stoppered, 100-mL conical flask, add 30.0 mL of chloroform, insert the stopper tightly, and shake for 30 minutes, using a mechanical wrist-action shaker, or equivalent. Filter with suction through a medium- or fine-porosity, sintered-glass filter, into a small filter flask. Wash the conical flask and the filter with two 5-mL portions of chloroform, adding the washings to the filtrate. Transfer the filtrate with the aid of chloroform to a 50-mL volumetric flask, add chloroform to volume, and mix. Pipet 20 mL of the resulting solution into a 250-mL conical flask containing 160 mL of solvent hexane. Gently swirl, allow to stand for 10 minutes, and transfer the resulting precipitate to a tared, fine-porosity, sintered-glass filter, wash the flask and the precipitate with two 20-mL portions of solvent hexane, dry the precipitate at 70 for 1 hour, and weigh the Hexane-insoluble matter so obtained. Multiply by 2.5 to find the amount present in the quantity of Podophyllum Resin taken.
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Topic/Question Contact Expert Committee
Monograph Maged H. Sharaf, Ph.D.
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(DS2010) Monographs - Dietary Supplements
USP35–NF30 Page 4345