Pregelatinized Starch is a process of breaking down the inter-molecular bonds of starch in the presence of water and heat. It is a kind of starch cooked and then dried on a drum dryer or in an extruder making the starch cold-water-soluble. Pregelatinized Starch is either potato or corn starch that have been dried and cooked prior to being used in pharmaceuticals or manufactured food products. They are designed to be easily digestible.
TEST
ITEMS
STANDARD
RESULTS
Character
White
powder, odorless
White powder,
odorless
Identification
Complies
Conforms
Acidity
4.5-7.0
6.4
Loss on
drying
≤14.0%
1.4%
Ash
≤0.5%
0.3%
Iron
≤20PPM
<20PPM
Sulfur
Dioxide
≤80PPM
<80PPM
Oxidizing
substances
≤20PPM
<20PPM
Total aerobic
Microbial Count
NMT1000Cfu/g
Conforms
Total yeast
& mould count
NMT100Cfu/g
Conforms
Escherchia
Coil & Salmonella
Absence
Conforms
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