Tapioca Starch

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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1 DEFINITION

Tapioca Starch consists of starch granules separated from the tubers of tapioca (cassava) [Manihot utilissima Pohl (Fam. Euphorbiaceae)].

2 IDENTIFICATION

2.1 A.

Analysis: Examine Tapioca Starch under a microscope, using not less than 20× magnification and using Glycerin as the mounting agent.

Acceptance criteria: It appears as spherical granules, each having one truncated side, typically having a 5- to 35-µm diameter, and having circular or several-rayed central clefts.

2.2 B.

Sample suspension: 1 g of Tapioca Starch in 50 mL of water

Analysis: Boil the Sample suspension for 1 min, and cool.

Acceptance criteria: A thin, cloudy mucilage is formed.

2.3 C.

Sample: The mucilage obtained in Identification test B

Analysis: To 1 mL of the Sample add 0.05 mL of iodine and potassium iodide TS 2.

Acceptance criteria: An orange-red to dark blue color is produced, which disappears on heating.

3 IMPURITIES

3.1 Residue on Ignition 〈281〉

Sample: 1.0 g

Acceptance criteria: NMT 0.6%

Change to read:

3.2 Iron 〈241〉, Procedures, Procedure 1 (CN 1-Jun-2023)

Test preparation: Shake 0.75 g of Tapioca Starch with 15 mL of 0.1 N hydrochloric acid, filter, and use 10 mL.

Acceptance criteria: NMT 20 µg/g

3.3 Limit of Oxidizing Substances

Sample: 4.0 g

Blank: 50 mL of water

Titrimetric system

(See Titrimetry 〈541〉.)

Mode: Direct titration

Titrant: 0.002 N sodium thiosulfate VS

Endpoint detection: Visual

Analysis: Transfer the Sample to a glass-stoppered, 125-mL conical flask, and add 50.0 mL of water. Insert the stopper, and swirl for 5 min. Decant into a glass-stoppered, 50-mL centrifuge tube, and centrifuge to clarify. Transfer 30.0 mL of the clear supernatant to a glass-stoppered, 125-mL conical flask. Add 1 mL of glacial acetic acid and 0.5–1.0 g of potassium iodide. Insert the stopper, swirl, and allow to stand for 25–30 min in the dark. Add 1 mL of starch TS, and titrate with Titrant to the disappearance of the starch–iodine color. Perform a blank determination, and make any necessary correction. Each mL of 0.002 N sodium thiosulfate VS is equivalent to 34 µg of oxidant, calculated as Hydrogen peroxide.

Acceptance criteria: NMT 1.4 mL of 0.002 N sodium thiosulfate VS is required (0.002%).

3.4 Limit of Sulfur Dioxide

Sample solution: Mix 20 g of Tapioca Starch with 200 mL of water until a smooth suspension is obtained, and filter.

Analysis: To 100 mL of the clear filtrate from the Sample solution add 3 mL of starch TS, and titrate with 0.01 N iodine solution VS to the first permanent blue color.

Acceptance criteria: NMT 1.7 mL of 0.01 N iodine solution VS is required (0.005%).

4 SPECIFIC TESTS

Microbial Enumeration Tests 〈61〉 and Tests for Specified Microorganisms 〈62〉: The total aerobic microbial count does not exceed 10³ cfu/g, and the total combined yeasts and molds count does not exceed 10² cfu/g. Tapioca Starch meets the requirements of the test for absence of Escherichia coli.

pH 〈791〉

Sample: 20.0 ± 0.1 g

Analysis: Transfer the Sample to a suitable nonmetallic container, and add 100 mL of water to obtain a slurry. Agitate continuously at a moderate rate for 5 min, then stop agitation, and immediately determine the pH.

Acceptance criteria: 4.5–7.0

Loss on Drying 〈731〉

Analysis: Dry at 130° for 90 min.

Acceptance criteria: NMT 16.0%

5 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in well-closed containers. No storage requirements specified.