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 40.0percent and not more than 50.0percent 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 1Npotassium hydroxide or in 1Nsodium hydroxide,forming a yellow liquid,which gradually becomes darker on standing and from which the resin is precipitated by hydrochloric acid.
B: Ahot 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 á281ñ: not more than 1.5%.
Distinction from resin of Indian podophyllum— Add 400mg to 3mLof 60percent alcohol,then add 0.5mLof 1Npotassium hydroxide,shake the mixture gently,and allow to stand for 2hours:it does not gelatinize.
Hexane-insoluble matter— Transfer about 1g of Podophyllum Resin,accurately weighed,to a glass-stoppered,100-mLconical flask,add 30.0mLof chloroform,insert the stopper tightly,and shake for 30minutes,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-mLportions of chloroform,adding the washings to the filtrate.Transfer the filtrate with the aid of chloroform to a 50-mLvolumetric flask,add chloroform to volume,and mix.Pipet 20mLof the resulting solution into a 250-mLconical flask containing 160mLof solvent hexane.Gently swirl,allow to stand for 10minutes,and transfer the resulting precipitate to a tared,fine-porosity,sintered-glass filter,wash the flask and the precipitate with two 20-mLportions of solvent hexane,dry the precipitate at 70for 1hour,and weigh the Hexane-insoluble matterso obtained.Multiply by 2.5to find the amount present in the quantity of Podophyllum Resin taken.
Auxiliary Information— Staff Liaison:Gabriel I.Giancaspro,Ph.D.,Senior Scientist and Latin American Specialist
Expert Committee:(DSB)Dietary Supplements:Botanicals
USP28–NF23Page 1572
Phone Number:1-301-816-8343