Era-Tab SP
Co-Spray Dried Rice Starch and colloidal silicon dioxide (USP44/NF39)
Era-Tab SP is an agglomerated form of rice starch and colloidal silicon dioxide (aerosil), obtained by co-spray drying of rice starch and colloidal silicon dioxide. Era-Tab SP is a dry white, odorless tasteless, insoluble, neutral and free-flowing powder and suitable for direct compression filler in tablet formulation.
Era-Tab SP used as a tablet filler that can be compressed at low moisture content environment. In making the medicinal tablet, the hardness is higher than Era-Tab of the same compression force.
Specifications
Loss on Drying |
Not more than 15% |
Residue on Ignition |
Not more than 1.5% |
Iron |
Not more than 20 ppm |
pH |
5.0-8.0 |
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 |
Specification of raw materials for co-spray dried of Era-Tab SP
Rice Starch (USP44/NF39)
Loss on Drying |
Not more than 15% |
Sufate Ash |
Not more than 0.6% |
Iron |
Not more than 10 ppm |
pH |
5.0-8.0 |
Oxidizing Substance |
Not more than 20 ppm |
Sulfur Dioxide |
Not morethan 50 ppm |
Salmonella |
- |
Escherichia Coli |
Absence |
Total Aerobic Microbial Count |
Not exceed 1000 cfu/g |
Total Combined Mold and Yeasts |
Not exceed 100 cfu/g |
Colloidal Silicon Dioxide (USP44/NF39)
Content Silicon Dioxides |
e 99.0-100.5% |
Loss on Drying |
Not more than 2.5% |
Loss on Ignition |
Not more than 2.0% |
Arsenic |
Not more than 8 ppm |
pH |
3.5-5.5 |