Pregelatinized Modified Starch

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

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

DOWNLOAD PDF HERE

1 DEFINITION 

Pregelatinized Modified Starch is Modified Starch that has been chemically or mechanically processed, or both, to rupture all or part of the granules to produce a product that swells in cold water. 

2 IDENTIFICATION 

A.

Sample: 0.6 g 

Analysis: Transfer the Sample to a 25-mL glass vial with a plastic cap. Add 9.4 g of water, cap, and shake vigorously to evenly disperse the starch. Add 10 g of 2% (w/w) NaOH solution, cap, and shake vigorously for 1 min to create a smooth mixture. Evaluate within 1 min. Acceptance criteria: The nal solution is translucent to opaque with a uid consistency. A yellow tint of the nal solution is acceptable.

B. An aqueous dispersion of Pregelatinized Modified Starch is colored orange-red to deep blue by iodine TS. 

3 IMPURITIES 

Residue on Ignition 〈281〉 

Sample: 2.0 ± 0.1 g 

Acceptance criteria: NMT 1.5% 

Limit of Sulfur Dioxide 

Sample solution: Mix 20.0 ± 0.1 g of Pregelatinized Modified Starch with 100 mL of 95% alcohol, and stir for several min to completely wet the starch. 

Analysis: Slowly add 100 mL of water to the Sample solution, and stir until a smooth suspension is obtained. Allow the starch mixture to set undisturbed until most of the starch has settled, and filter the aqueous portion through paper (Whatman No. 1 or equivalent). To 100 mL of the clear filtrate add 100 mL of water. Add 3 mL of starch TS, and titrate with 0.01 N iodine VS to the first permanent blue or purple color. Acceptance criteria: NMT 1.7 mL of 0.010 N iodine is consumed (NMT 0.005%). 

4 SPECIFIC TESTS 

pH 〈791〉 

Sample: 10.0 ± 0.1 g 

Analysis: Wet the Sample with 10 mL of alcohol, then dilute with water to 300 mL to obtain an aqueous dispersion. Stir continuously at a moderate rate for 5 min, and determine the pH to the nearest 0.1 unit. 

Acceptance criteria: 3.0–9.0 

Loss on Drying 〈731〉 

Analysis: Dry at 120° for 4 h. 

Acceptance criteria: NMT 15% 

Microbial Enumeration Tests 〈61〉andTests for Specified Microorganisms 〈62〉: The total aerobic microbial count does not exceed 1 × 10³ cfu/g, and the total combined molds and yeasts count does not exceed 1 × 10² cfu/g. It meets the requirements of the tests for absence of Salmonella species and Escherichia coli. 

Change to read: 

Iron 〈241〉, Procedures, Procedure 1  

Sample: The residue obtained in the test for Residue on Ignition 〈281〉 

Analysis: Dissolve the Sample in 8 mL of hydrochloric acid with the aid of gentle heating. Dilute with water to 100 mL in a volumetric ask. Dilute 25 mL of this solution with water to 47 ± 1 mL. 

Acceptance criteria: NMT 20 µg/g 

Oxidizing Substances 

Sample solution: To 5 g of Pregelatinized Modified Starch add 20 mL of a mixture of methanol and water (1:1). 

Analysis: To the Sample solution 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. 

5 ADDITIONAL REQUIREMENTS 

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