U.S. PHARMACOPEIA

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Topical Starch
» Topical Starch consists of the granules separated from the mature grain of corn [Zea mays Linné (Fam. Gramineae)].
Packaging and storage— Preserve in well-closed containers.
Botanic characteristics— Polygonal, rounded or spheroidal granules up to about 35 µm in diameter and usually having a circular or several-rayed central cleft.
Identification—
A: Prepare a smooth mixture of 1 g of it with 2 mL of cold water, stir it into 15 mL of boiling water, boil gently for 2 minutes, and cool: a translucent, whitish jelly is produced.
B: A water slurry of it is colored reddish violet to deep blue by iodine TS.
Microbial limits 61 The total aerobic microbial count does not exceed 500 cfu per g and the total combined molds and yeasts count does not exceed 50 cfu per g.
pH 791 Prepare a slurry by weighing 20.0 g ± 100 mg of Topical Starch, transferring to a suitable nonmetallic container, and adding 100 mL of water. Agitate continuously at a moderate rate for 5 minutes, then stop agitation, and immediately determine the pH to the nearest 0.1 unit: the pH, determined potentiometrically, is between 4.5 and 7.0.
Loss on drying 731 Dry it at 120 for 4 hours: it loses not more than 14.0% of its weight.
Residue on ignition 281: not more than 0.5%, determined on a 2.0-g test specimen ignited at a temperature of 575 ± 25.
Iron 241 Dissolve the residue obtained in the test for Residue on ignition in 4 mL of hydrochloric acid with the aid of gentle heating, dilute with water to 50 mL, and mix. Dilute 25 mL of the resulting solution with water to 47 mL: the limit is 0.001%.
Oxidizing substances— Transfer 4.0 g to a glass-stoppered, 125-mL conical flask, and add 50.0 mL of water. Insert the stopper, and swirl for 5 minutes. Decant into a glass-stoppered, 50-mL centrifuge tube, and spin to clarify. Transfer 30.0 mL of clear supernatant to a glass-stoppered, 125-mL conical flask. Add 1 mL of glacial acetic acid and 0.5 g to 1.0 g of potassium iodide. Insert the stopper, swirl, and allow to stand for 25 to 30 minutes in the dark. Add 1 mL of starch TS, and titrate with 0.002 N sodium thiosulfate VS to the disappearance of the starch-iodine color. Each mL of 0.002 N sodium thiosulfate is equivalent to 34 µg of oxidant, calculated as hydrogen peroxide. Not more than 12.6 mL of 0.002 N sodium thiosulfate is required (0.018%).
Sulfur dioxide— Mix 20 g with 200 mL of water to obtain a smooth suspension, and filter. To 100 mL of the clear filtrate add 3 mL of starch TS, and titrate with 0.01 N iodine VS to the first permanent blue color: not more than 2.7 mL is consumed (0.008%).
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 2005
Pharmacopeial Forum : Volume No. 29(3) Page 669
Phone Number : 1-301-816-8351