Pregelatinized Starch
» Pregelatinized Starch is Starch that has been chemically and/or mechanically processed to rupture all or part of the granules in the presence of water and subsequently dried. Some types of Pregelatinized Starch may be modified to render them compressible and flowable in character.
Packaging and storage— Preserve in well-closed containers. No storage requirements specified.
Labeling— Label it to indicate the botanical source from which it was derived.
Identification— A water slurry of it is colored orange-red to deep blue by iodine TS.
Microbial enumeration tests 61 and Tests for specified microorganisms 62 It meets the requirements of the tests for absence of Salmonella species and Escherichia coli. The total aerobic microbial count does not exceed 1000 cfu per g, and the total combined molds and yeasts count does not exceed 100 cfu per g.
pH 791 Prepare a slurry by weighing 10.0 ± 0.1 g in 10 mL of alcohol and by diluting with water to 100 mL. Agitate continuously at a moderate rate for 5 minutes, then cease agitation, and immediately determine the pH to the nearest 0.1 unit: the pH is between 4.5 and 7.0, determined potentiometrically.
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.
Iron 241 Dissolve the residue obtained in the test for Residue on ignition in 8 mL of hydrochloric acid with the aid of gentle heating, dilute with water to 100 mL, and mix. Dilute 25 mL of this solution with water to 47 mL: the limit is 0.002%.
Oxidizing substances— To 5 g add 20 mL of a mixture of equal volumes of methanol and water, then add 1 mL of 6 N acetic acid, and stir until a homogeneous suspension is obtained. Add 0.5 mL of a freshly prepared, saturated solution of potassium iodide, mix, and allow to stand for 5 minutes: no distinct blue, brown, or purple color is observed.
Limit of sulfur dioxide— Mix 20 g with 200 mL of a 1 in 5 solution of anhydrous sodium sulfate, 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%).
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Kevin T. Moore, Ph.D.
(EM205) Excipient Monographs 2
61 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
(MSA05) Microbiology and Sterility Assurance
62 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 1356
Pharmacopeial Forum: Volume No. 30(3) Page 997
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.