Pregelatinized Starch

Pregelatinized starch is a product of arrowroot, corn, potato, and wheat flour. The flaked and powdered form of the product is used in several industries such as food and beverages and pharmaceuticals. Pregelatinized starch is a starch that has been pre-cooked, dried and ground into flake or powder form. Quickly and easily dissolving in cold liquids, pregelatinized starches allow products to develop full viscosity without cooking. Pregelatinized starches are convenient and easy to use, providing an ideal solution for products such as instant soups, baby foods and baked goods. Pregelatinized starch can be used in various applications in the pharmaceutical and nutraceutical industries. It is mainly used as excipient, thickener, stabilizer, moisture retention agent, etc.

Specifications of Pregelatinized Starch USP NF Grade:

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.
Residue on Ignition: NMT 0.5%, determined on a 2.0-g test specimen.
Iron: NMT 20 ppm.
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).
Microbial Enumeration Tests and Tests for Specified Microorganisms: 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: 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: 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.
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.

Specifications of Pregelatinized Modified Starch USP NF Grade:

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.

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 final solution is translucent to opaque with a fluid consistency. A yellow tint of the final solution is acceptable.
B. An aqueous dispersion of Pregelatinized Modified Starch is colored orange red to deep blue by iodine TS.

Residue on Ignition:
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%).
pH:
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:
Analysis: Dry at 120C for 4 h.
Acceptance criteria: NMT 15%
Microbial Enumeration Tests and Tests for Specified Microorganisms: 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.
Iron:
Sample: The residue obtained in the test for Residue on Ignition
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 flask. 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.
Packaging & Storage: Preserve in well-closed containers. No storage requirements specified.

Specifications of Pregelatinized Hydroxypropyl Corn Starch USP NF Grade:

DEFINITION
Pregelatinized Hydroxypropyl Corn Starch is prepared from Hydroxypropyl Corn Starch by mechanical processing in the presence of water, with or without heat, to rupture all or some of the starch granules, and is subsequently dried. It contains NLT 2.0% and NMT 7.0% of hydroxypropyl groups on the dried basis.

IDENTIFICATION

A. Test for Pregelatinized State:
Sample: 1 g
Analysis: Disperse the Sample in 50 mL of water at a temperature NMT 25°. Shake vigorously until lumps completely disperse/solubilize or until lumps disappear. Allow to stand for 20 min.
Acceptance criteria: A translucent or clear mucilage without precipitate is formed.
B. Test for Starch:
Analysis: Disperse 0.5 g in 2 mL of water without heating, and add 0.05 mL of iodine and potassium iodide.
Acceptance criteria: A reddish-violet or blue color is produced.
C. Ninhydrin Test:
Ninhydrin solution:  Dissolve 3 g of ninhydrin in 100 mL of a 45.5-g/L solution of sodium metabisulfite.
Diluted sulfuric acid:  98 g/L of H2SO4
Sample: 100 mg
Analysis: Transfer the Sample to a 100-mL volumetric flask, and add 12.5 mL of Diluted sulfuric acid. Place the flask in a water bath, and heat until the Sample is dissolved. Cool, and dilute with water to 100 mL. [Caution— When sulfuric acid is miscible with water, it produces intense heat. ]
Pipet 1 mL of this solution to a glass-stoppered 25-mL graduated test tube and, with the tube immersed in cold water, add dropwise 8 mL of sulfuric acid. Mix well and place the tube in a boiling water bath for exactly 3 min. Immediately transfer the tube to an ice bath until the solution is chilled. Add 0.6 mL of Ninhydrin solution, carefully allowing the reagent to run down the walls of the test tube. Immediately shake the tube well and place it in a water bath at 25C for 100 min. Dilute with sulfuric acid to 25 mL. [Caution— Use sulfuric acid cautiously. ] Mix by inverting the tube several times. Do not shake.
Acceptance criteria: A violet color develops within 5 min due to the presence of hydroxypropyl groups (starch ether).

ASSAY
Assay for Hydroxypropyl Groups: To pass the test.
Acceptance criteria: 2.0%–7.0% of hydroxypropyl groups on the dried basis.

Residue on Ignition: NMT 0.6%, determined on a 1.0-g test specimen.
Limit of Iron: To pass the test.
Acceptance criteria: After 5 min, any pink color in the Sample solution is not more intense than that in the Standard solution, corresponding to a limit of 20 ppm of iron.
Limit of Sulfur Dioxide: NMT 50 ppm.
Limit of Propylene Glycol: To pass the test.
Acceptance criteria: NMT 0.1%
Limit of Oxidizing Substances:
Sample: 4.0 g
Analysis: Transfer the Sample to a glass-stoppered 125-mL conical flask, and add 50.0 mL of a mixture of water and methanol (1:1). Insert the stopper, and swirl for 5 min. Transfer to 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 0.002 N sodium thiosulfate 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 is required (20 ppm, calculated as H2O2 ).
Microbial Enumeration Tests and Tests for Specified Microorganisms: The total aerobic microbial count does not exceed 103 cfu/g, the total combined molds and yeasts count does not exceed 102 cfu/g, and it meets the requirements of the test for the absence of Escherichia coli.
pH:
Sample solution: Progressively suspend 3.0 g of Pregelatinized Hydroxypropyl Corn Starch in 100.0 mL of carbon dioxide-free water, stirring continuously. Determine the pH when all the solid is wetted.
Acceptance criteria: 4.5–8.0
Loss on Drying: Dry about 1 g at 130C for 90 min: it loses NMT 15.0% of its weight.
Packaging and Storage: Preserve in well-closed containers. Store at room temperature.

Specifications of Pregelatinised Starch BP Ph Eur Grade:

Pregelatinised Maize Starch
When Pregelatinised Starch is prepared Zea mays, the title Pregelatinised Maize Starch may be used.

DEFINITION
Pregelatinised starch is prepared from:
Maize starch (0344), Potato starch (0355) or Rice starch (0349) by mechanical processing in the presence of water, with or without heat, to rupture all or part of the starch granules, and subsequent drying. It contains no added substances, but it may be modified to render it compressible and to improve its flow characteristics.

CHARACTERS
Appearance: White or yellowish-white powder.
It swells in cold water.

IDENTIFICATION
A. Examined under a microscope using a mixture of equal volumes of glycerol and water it presents irregular, translucent, white or yellowish-white flakes or pieces with an uneven surface. Under polarised light (between crossed nicol prisms), starch granules with a distinct black cross intersecting at the hilum may be seen.
B. Disperse 0.5 g in 2 mL of water without heating and add 0.05 mL of iodine solution. A reddish-violet or blue colour is produced.

TESTS
pH: 4.5 to 7.0.
Progressively add 3.0 g to 100.0 mL of carbon dioxide-free water, stirring continuously. Determine the pH when a homogeneous solution is obtained.
Oxidising substances: To pass the test.
Sulfur dioxide: Maximum 50 ppm.
Iron: Maximum 20 ppm.
Foreign matter:
Examined under a microscope using a mixture of equal volumes of glycerol and water, not more than traces of matter other than starch granules are present.
Loss on drying: Maximum 15.0 per cent, determined on 1.000 g by drying in an oven at 130C for 90 min.
Sulfated ash: Maximum 0.6 per cent, determined on 1.0 g.
Microbial contamination:
TAMC: acceptance criterion 1000 CFU/g.
TYMC: acceptance criterion 1000 CFU/g.
Absence of Escherichia coli.
Absence of Salmonella.

LABELLING
The label states the type of starch used as starting material.

Specifications of Pregelatinised Hydroxypropyl Starch BP Ph Eur Grade:

IDEFINITION
Pregelatinised hydroxypropyl starch is prepared from Starch, hydroxypropyl (2165) by mechanical processing in the presence of water, with or without heat, to rupture all or part of the starch granules, and subsequent drying.
Content: — hydroxypropyl groups: 0.5 per cent to 7.0 per cent.

PRODUCTION
The production of pregelatinised hydroxypropyl starch shall be following the requirements of the European legislation for food additives.

CHARACTERS
Appearance: White or slightly yellowish powder.

IDENTIFICATION
A. It swells in cold water.
B. Disperse 0.5 g in 2 mL of water, without heating, and add 0.05 mL of iodine solution. A reddish-violet or greyish-blue colour is produced.
C. To 0.1 g add 12.5 mL of dilute sulfuric acid. Heat in a water-bath until the sample is dissolved. Cool and dilute to 100 mL with water. Introduce 1 mL of the solution into a 25 mL graduated test-tube with a ground-glass stopper and, with the tube immersed in cold water, add dropwise 8 mL of sulfuric acid. Mix well and place the tube in a boiling water-bath for exactly 3 min. Immediately transfer the tube to an ice-bath until the solution is chilled. Add 0.6 mL of ninhydrin solution, carefully allowing the reagent to run down the walls of the test-tube. Immediately shake well and place the tube in a water-bath at 25C for 100 min. Dilute to 25 mL with sulfuric acid and mix by inverting the tube several times. Do not shake. A violet colour develops within 5 min.

TESTS
pH: 4.5 to 8.0.
Progressively add 3.0 g to 100.0 mL of carbon dioxide-free water, stirring continuously. Determine the pH when a homogeneous solution is obtained.
Impurity A: To pass the test by gas chromatography.
Limit: — impurity A: maximum 0.1 per cent.
Oxidising substances: Maximum 20 ppm, calculated as H2O2.
Sulfur dioxide: Maximum 50 ppm.
Iron:
— For pregelatinised hydroxypropyl starch obtained from maize, potato, cassava or rice: maximum 20 ppm.
— For pregelatinised hydroxypropyl starch obtained from pea: maximum 50 ppm.
Loss on drying: Determined on 1.000 g by drying in an oven at 130C for 90 min:
— maximum 15.0 per cent for pregelatinised hydroxypropyl starch obtained from maize, cassava, rice or pea;
— maximum 20.0 per cent for pregelatinised hydroxypropyl starch obtained from potato.
Sulfated ash: Maximum 0.6 per cent, determined on 1.0 g.
Microbial contamination:
TAMC: acceptance criterion 1000 CFU/g.
TYMC: acceptance criterion 100 CFU/g.
Absence of Escherichia coli.
Absence of Salmonella.

ASSAY
To pass the test.

LABELLING
The label states the botanical source of the starch and the type of modification.

IMPURITIES
A. (2RS)-propane-1,2-diol (propylene glycol).

We can supply Unigel 270 and Unigel 500 starch.
UniGel 270 is pharma grade corn pre-gelatinized starch.
UniGel 500 is food grade corn pre-gelatinised starch.

Certifications :
We manufacture Bulk Drugs / API, Excipients, Pharmaceuticals (IP/BP/USP/NF/Ph. Eur, JP/ CP), Speciality Chemicals(Pure/AR/ACS), Mineral Fortifiers, Food Chemical Codex (FCC) and Flavour chemicals. Our manufacturing facility is cGMP, GLP, ISO 9001, ISO 14001, ISO 22000, ISO/IEC 17025, FSSC 22000, FSSAI, Kosher, HALAL, EXCiPACT, WC, COPP, WHO-GMP and WC certified. We are also REACH registered for export to European countries.