Starch Corn Starch Maize

British Pharmacopoeia
Maize Starch Corn Starch

Maize Starch BP ( Corn Starch )

Action and use
Excipient.

When Starch is specified and the type is not indicated, Maize Starch, Potato Starch, Rice Starch, Wheat Starch or, in tropical countries where these are not available, Tapioca Starch may be supplied or used.

DEFINITION
Maize starch ( Corn Starch ) is obtained from the caryopsis of Zea mays L.

CHARACTERS
Appearance
Matt, white to slightly yellowish, very fine powder which creaks when pressed between the fingers.
Solubility
Practically insoluble in cold water and in ethanol (96 per cent). The presence of granules with cracks or irregularities on the edge is exceptional.

IDENTIFICATION
A. Examined under a microscope, using not less than 20 × magnification and using equal volumes of glycerol and water, it appears as either angular polyhedral granules of irregular sizes with diameters ranging from about 2 μm to about 23 μm or as rounded or spherical granules of irregular sizes with diameters ranging from about 25 μm to about 35 μm. The central hilum consists of a distinct cavity or two-to five-rayed cleft and there are no concentric striations. Between crossed nicol prisms, the starch granules show a distinct black cross intersecting at the hilum.
B. Suspend 1 g in 50 ml of water, boil for 1 min and cool. A thin, cloudy mucilage is formed.
C. To 1 ml of the mucilage obtained in identification test B add 0.05 ml of iodine solution. An orange-red to dark blue colour is produced which disappears on heating.

TESTS
pH
4.0 to 7.0.
Shake 5.0 g with 25.0 ml of carbon dioxide-free water for 60 s. Allow to stand for 15 min.
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. No starch grains of any other origin are present.
Oxidizing substances
Maximum 20 ppm, calculated as H2O2.
Sulphur dioxide
Maximum 50 ppm.
Iron
Maximum 10 ppm.
Loss on drying
Maximum 15.0 per cent, determined on 1.000 g by drying in an oven at 130 °C for 90 min.
Sulphated ash
Maximum 0.6 per cent, determined on 1.0 g.
Microbial contamination
Total viable aerobic count not more than 103 bacteria and 102 fungi per gram, determined by plate count. It complies with the test for Escherichia coli.

Corn Starch USP NF ( Maize Starch )

Corn Starch ( Maize Starch ) consists of the starch granules separated from the mature grain of corn

Identification—
A: Under a microscope, using not less than 20× magnification and using a mixture of glycerin and water (1:1) as a mounting agent, it appears either as angular polyhedral granules of irregular sizes with diameters ranging from about 2 µm to about 23 µm, or as rounded or spherical granules of irregular sizes with diameters ranging from about 25 µm to about 35 µm. The central hilum consists of a distinct cavity or two- to five-rayed cleft, and there are no concentric striations. Between crossed nicol prisms, the starch granules show a distinct black cross intersecting at the hilum.
B: Suspend 1 g of it in 50 mL of water, boil for 1 minute, and cool: a thin, cloudy mucilage is formed.
C: To 1 mL of the mucilage obtained in Identification test B, add 0.05 mL of iodine and potassium iodide TS 2: an orange-red to dark blue color is produced, which disappears on heating.
Microbial limits— The total aerobic microbial count does not exceed 1000 cfu per g, the total combined molds and yeasts count does not exceed 100 cfu per g, and it meets the requirements of the test for the absence of Escherichia coli. Where it is intended for use in preparing Absorbable Dusting Powder, it also meets the requirements of the tests for absence of Staphylococcus aureus and Pseudomonas aeruginosa.
pH— Prepare a slurry by weighing 5.0 g of Corn Starch, transferring to a suitable nonmetallic container, and adding 25.0 mL of freshly boiled and cooled water. Agitate continuously at a moderate rate for 1 minute. Stop the agitation, and allow to stand for 15 minutes. Determine the pH to the nearest 0.1 unit: the pH, determined potentiometrically, is between 4.0 and 7.0.
Loss on drying— Dry about 1 g, accurately weighed, at 130 for 90 minutes: it loses not more than 15.0% of its weight.
Residue on ignition: not more than 0.6%, determined on a 1.0-g test specimen.
Limit of iron—a limit of 10 µg of iron per g.
Limit of oxidizing substances—20 µg per g, calculated as H2O2.
Limit of sulfur dioxide: not more than 50 µg per g.

Certifications :
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