Delete the following:
Starch

Starch.
Starch [9005-25-8].
»Starch consists of the granules separated from the mature grain of corn [Zea maysLinné(Fam.Gramineae)]or of wheat [Triticum aestivumLinné(Fam.Gramineae)],or from tubers of the potato [Solanum tuberosumLinné(Fam.Solanaceae)].
NOTE—Starches obtained from different botanical sources may not have identical properties with respect to their use for specific pharmaceutical purposes,e.g.,as a tablet-disintegrating agent.Therefore,types of starch should not be interchanged unless performance equivalency has been ascertained.
Packaging and storage— Preserve in well-closed containers.
Labeling— Label it to indicate the botanical source from which it was derived.
Botanic characteristics—
Corn starch— Polygonal,rounded or spheroidal granules up to about 35µm in diameter and usually having a circular or several-rayed central cleft.
Wheat starch— Two distinct types of granules are simple lenticular large granules 20to 25µm or up to 50µm in diameter,and small spherical granules 5to 10µm in diameter.Striations are faintly marked and concentric.
Potato starch— Simple granules,irregularly ovoid or spherical,30to 100µm in diameter,and subspherical granules 10to 35µm in diameter.Striations are well marked and concentric.
Identification—
A: Prepare a smooth mixture of 1g of it with 2mLof cold water,stir it into 15mLof boiling water,boil gently for 2minutes,and cool:the product is a translucent,whitish jelly.
B: Awater slurry of it is colored reddish violet to deep blue by iodine TS.
Microbial limits á61ñ— It meets the requirements of the tests for absence of Salmonellaspecies and Escherichia coli.
pHá791ñ— Prepare a slurry by weighing 20.0g ±100mg of Starch,transferring to a suitable nonmetallic container,and adding 100mLof water.Agitate continuously at a moderate rate for 5minutes,then stop agitation,and immediately determine the pHto the nearest 0.1unit:the pH,determined potentiometrically,is between 4.5and 7.0for Corn starch and Wheat starch,and is between 5.0and 8.0for Potato starch.
Loss on drying á731ñ— Dry it at 120for 4hours:it loses not more than 14.0%of its weight.
Residue on ignition á281ñ: not more than 0.5%,determined on a 2.0-g test specimen.
Iron á241ñ— Dissolve the residue obtained in the test for Residue on ignitionin 8mLof hydrochloric acid with the aid of gentle heating,dilute with water to 100mL,and mix.Dilute 25mLof this solution with water to 47mL:the limit is 0.002%.
Oxidizing substances— Transfer 4.0g to a glass-stoppered,125-mLconical flask,and add 50.0mLof water.Insert the stopper,and swirl for 5minutes.Decant into a glass-stoppered,50-mLcentrifuge tube,and centifuge to clarify.Transfer 30.0mLof clear supernatant to a glass-stoppered,125-mLconical flask.Add 1mLof glacial acetic acid and 0.5g to 1.0g of potassium iodide.Insert the stopper,swirl,and allow to stand for 25to 30minutes in the dark.Add 1mLof starch TS,and titrate with 0.002Nsodium thiosulfate VSto the disappearance of the starch-iodine color.Perform a blank determination,and make any necessary correction.Each mLof 0.002Nsodium thiosulfate is equivalent to 34µg of oxidant,calculated as hydrogen peroxide.Not more than 1.4mLof 0.002Nsodium thiosulfate is required (0.002%).
Limit of sulfur dioxide— Mix 20g with 200mLof water until a smooth suspension is obtained,and filter.To 100mLof the clear filtrate add 3mLof starch TS,and titrate with 0.01Niodine VSto the first permanent blue color:not more than 2.7mLis consumed (0.008%).
Organic volatile impurities,Method IVá467ñ: meets the requirements.NF23
Auxiliary Information— Staff Liaison:Catherine Sheehan,B.Sc.,Scientist
Expert Committee:(EMC)Excipients:Monograph Content
USP28–NF23Page 3087
Pharmacopeial Forum:Volume No.30(2)Page 714
Phone Number:1-301-816-8262