Era-Gel
Pregelatinized Chemically Modified Starch (USP44/NF39)
Era-Gel is a disintegrant and binder for wet granulation process. Era-Gel is an entirely pregelatinized starch USP44/NF39 that has been heated to rupture all of the granules in the presence of water and subsequently dried.
Era-Gel is a physically modified starch. With the addition of water to Era-Gel, a viscous, slurry suspension, similar to starch paste is obtained. The advantage is that one can prepare starch paste from Era-Gel at room temperature. It can also be dry mixed first with the other excipients, then with water. Therefore, the amounts of dry binder as well as water can be easily controlled.
Specifications
Loss on Drying |
Not more than 14% |
Residue on Ignition |
Not more than 0.5% |
Iron |
Not more than 20 ppm |
pH |
4.5-7.0 |
Oxidizing Substance |
Conforms |
Sulfur Dioxide |
Not morethan 80 ppm |
Microbial Limits
Salmonella |
Absence |
Escherichia Coli |
Absence |
Total Aerobic Microbial Count |
Not exceed 1000 cfu/g |
Total Combined Mold and Yeasts |
Not exceed 100 cfu/g |