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Pregelatinized Starch

The document outlines the specifications and testing requirements for Pregelatinized Starch, including its definition, identification methods, and limits for impurities such as inorganic substances and microbial counts. It specifies acceptable ranges for pH, loss on drying, and limits for sulfur dioxide and iron content. Additionally, it includes guidelines for packaging, storage, and labeling of the product.

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73 views1 page

Pregelatinized Starch

The document outlines the specifications and testing requirements for Pregelatinized Starch, including its definition, identification methods, and limits for impurities such as inorganic substances and microbial counts. It specifies acceptable ranges for pH, loss on drying, and limits for sulfur dioxide and iron content. Additionally, it includes guidelines for packaging, storage, and labeling of the product.

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© © All Rights Reserved
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Printed on: Thu Feb 09 2023, 12:54:53 AM(EST) Status: Currently Official on 09-Feb-2023 DocId: GUID-D6A0EFC8-6C35-4F36-90C8-F57AB8666A72_1_en-US

Printed by: Dang Van Vu Official Date: Official Prior to 2013 Document Type: NF @2023 USPC
Do Not Distribute DOI Ref: s847e DOI: https://doi.org/10.31003/USPNF_M78124_01_01
1

requirements of the tests for absence of Salmonella species


Pregelatinized Starch and Escherichia coli. The total aerobic microbial count does
DEFINITION not exceed 1000 cfu/g; and the total combined molds and
Pregelatinized Starch is Starch that has been chemically yeasts count does not exceed 100 cfu/g.
and/or mechanically processed to rupture all or part of the • PH á791ñ: 4.5–7.0
granules in the presence of water and subsequently dried. Prepare a slurry by weighing 10.0 ± 0.1 g in 10 mL of alcohol
Some types of Pregelatinized Starch may be modified to and by diluting with water to 100 mL. Agitate
render them compressible and flowable in character. continuously at a moderate rate for 5 min, then cease
agitation and immediately potentiometrically determine
IDENTIFICATION the pH to the nearest 0.1 unit.
• A water slurry of it is colored orange-red to deep blue by • LOSS ON DRYING á731ñ: Dry a sample at 120° for 4 h: it loses
iodine TS. NMT 14.0% of its weight.
• OXIDIZING SUBSTANCES
IMPURITIES Sample: 5 g
INORGANIC IMPURITIES Analysis: To the Sample add 20 mL of a mixture of equal
• Residue on Ignition á281ñ: NMT 0.5%, determined on a volumes of methanol and water, then add 1 mL of 6 N
2.0-g test specimen acetic acid, and stir until a homogeneous suspension is
• Iron á241ñ: NMT 20 ppm obtained. Add 0.5 mL of a freshly prepared, saturated
Analysis: Dissolve the residue obtained in the test for Residue solution of potassium iodide, and allow to stand for 5 min.
on Ignition in 8 mL of hydrochloric acid with the aid of gentle Acceptance criteria: No distinct blue, brown, or purple
heating, and dilute with water to 100 mL. Dilute 25 mL of color is observed.
this solution with water to 47 mL.
• LIMIT OF SULFUR DIOXIDE ADDITIONAL REQUIREMENTS

al
Sample solution: Mix 20 g with 200 mL of a 1-in-5 solution • PACKAGING AND STORAGE: Preserve in well-closed
of anhydrous sodium sulfate, and filter. containers. No storage requirements specified.
Analysis: To 100 mL of the clear filtrate add 3 mL of starch • LABELING: Label it to indicate the botanical source from
TS, and titrate with 0.01 N iodine VS to the first permanent which it was derived.
blue color. ci
Acceptance criteria: NMT 2.7 mL is consumed (80 ppm).
SPECIFIC TESTS
• MICROBIAL ENUMERATION TESTS á61ñ and TESTS FOR
SPECIFIED MICROORGANISMS á62ñ: It meets the
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