Edition: BP 2025 (Ph. Eur. 11.6 update)
General Notices
Cassava 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 and sub-tropical countries where these are not available, Tapioca Starch may be supplied or used.
DEFINITION
Tapioca Starch is obtained from the rhizomes of Manihot utilissima Pohl.
CHARACTERISTICS
Very fine powder which creaks when pressed between the fingers.
Practically insoluble in cold water and in ethanol (96%).
IDENTIFICATION
A. Principally simple granules, subspherical, muller-shaped or rounded polyhedral; smaller granules 5 to 10 μm, larger granules 20 to 35 μm in diameter; hilum, central, punctate, linear or triradiate; striations, faint, concentric; compound granules, few, of two to three unequal components.
B. Heat to boiling a suspension of 1 g in 50 mL of water for 1 minute and cool. A thin, cloudy mucilage is formed.
C. Mix 0.05 mL of iodine solution R1 with 1 mL of the mucilage obtained in test B. A dark blue colour is produced which disappears on heating and reappears on cooling.
TESTS
Acidity
Add 10 g of the starch to 100 mL of ethanol (70%) previously neutralised to 0.5 mL of phenolphthalein solution, shake for 1 hour, filter and titrate 50 mL of the filtrate with 0.1M sodium hydroxide VS. Not more than 2.0 mL is required to change the colour of the solution.
Foreign matter
Not more than traces of cell membranes and protoplasm are present.
Loss on drying
When dried to constant weight at 100° to 105°, loses not more than 15.0% of its weight. Use 1 g.
Sulfated ash
Not more than 0.6%, Appendix IX A, Method II. Use 1 g.
Microbial contamination
1.0 g is free from Escherichia coli, Appendix XVI B1.
STORAGE
Tapioca Starch should be kept in an airtight container.
