Pregelatinized Starch
DEFINITION
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.
IDENTIFICATION
• A water slurry of it is colored orange-red to deep blue by iodine TS.
IMPURITIES
Inorganic Impurities
• Residue on Ignition 
281
:
NMT 0.5%, determined on a 2.0-g test specimen
281:
NMT 0.5%, determined on a 2.0-g test specimen
• Iron 241:
NMT 20 ppm
241:
NMT 20 ppm
Analysis:
Dissolve the residue obtained in the test for Residue on Ignition in 8 mL of hydrochloric acid with the aid of gentle heating, and dilute with water to 100 mL. Dilute 25 mL of this solution with water to 47 mL.
• Limit of Sulfur Dioxide
Sample solution:
Mix 20 g with 200 mL of a 1 in 5 solution of anhydrous sodium sulfate, and filter.
Analysis:
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.
Acceptance criteria:
NMT 2.7 mL is consumed (80 ppm).
SPECIFIC TESTS
• 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/g; and the total combined molds and yeasts count does not exceed 100 cfu/g.
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/g; and the total combined molds and yeasts count does not exceed 100 cfu/g.
• pH 791:
4.5–7.0
791:
4.5–7.0
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 min, then cease agitation and immediately potentiometrically determine the pH to the nearest 0.1 unit.
• Loss on Drying 731:
Dry a sample at 120
for 4 h: it loses NMT 14.0% of its weight.
731:
Dry a sample at 120 for 4 h: it loses NMT 14.0% of its weight.
• Oxidizing Substances
Sample:
5 g
Analysis:
To the Sample 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, and allow to stand for 5 min.
Acceptance criteria:
No distinct blue, brown, or purple color is observed.
ADDITIONAL REQUIREMENTS
• 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.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Robert H. Lafaver, M.S.
Scientific Liaison 1-301-816-8335 |
(EXC2010) Monographs - Excipients |
| 61 |
Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison 1-301-816-8339 |
(GCM2010) General Chapters - Microbiology |
| 62 |
Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison 1-301-816-8339 |
(GCM2010) General Chapters - Microbiology |
USP35–NF30 Page 1972
Pharmacopeial Forum: Volume No. 30(3) Page 997