Rice Starch

(Ph. Eur. monograph 0349)

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.

Ph Eur

Rice starch is obtained from the caryopsis of Oryza sativa L.

Very fine, white or almost white powder, which creaks when pressed between the fingers.

Practically insoluble in cold water and in ethanol (96 per cent).

Rice starch does not contain starch grains of any other origin. It may contain traces of, if any, fragments of the endosperm tissue of the fruit.

A. Examined under a microscope using a mixture of equal volumes of glycerol R and water R, it presents polyhedral, simple grains 1-10 µm, mostly 4-6 µm, in size. These simple grains often gather in ellipsoidal, compound grains 50-100 µm in diameter. The grains have a poorly visible central hilum and there are no concentric striations. Between orthogonally orientated polarising plates or prisms, the starch grains show a distinct black cross intersecting at the hilum.

B. Suspend 1 g in 50 mL of water R, 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 R1. An orange-red to dark blue colour is produced, which disappears on heating.

5.0 to 8.0.

Shake 5.0 g with 25.0 mL of carbon dioxide-free water R for 60 s. Allow to stand for 15 min.

Maximum 10 ppm for the filtrate.

Shake 1.5 g with 15 mL of dilute hydrochloric acid R. Filter.

Examine under a microscope using a mixture of equal volumes of glycerol R and water R. Not more than traces of matter other than starch granules are present. No starch grains of any other origin are present.

Maximum 15.0 per cent, determined on 1.00 g by drying in an oven at 130 °C for 90 min.

Maximum 0.6 per cent, determined on 1.0 g.

Maximum 0.002 per cent, calculated as H₂O₂.

Maximum 50 ppm.

TAMC: acceptance criterion 10³ CFU/g (2.6.12).

TYMC: acceptance criterion 10² CFU/g (2.6.12).

Absence of Escherichia coli (2.6.13).

Absence of Salmonella (2.6.13).

Ph Eur