Pregel Starch
Pregelatinised starch is a multifunctional excipient that can be used as a tablet and capsule filler/diluent, wet granulation binder, and disintegrating agent.
It is mainly used in the formulation of solid dosage forms (tablets and capsules).
Specification of Pregel Starch
| Test | Specifications |
|---|---|
| Description | White or almost white, fine, granular powder, practically insoluble in water, in acetone, in ethanol, in toluene, in dilute acids and in 50 g/l solution of sodium hydroxide |
| Identification | Ph. Eur., USPNF |
| pH | 4.5 to 7 (Ph. Eur., USPNF) |
| Residue on Ignition | Max 0.5% (Ph. Eur., USPNF) |
| Loss on Drying | Max 14% (Ph. Eur., USPNF) |
| Heavy Metals | Max 10 ppm |
| Loose Bulk Density | 0.50 to 0.60 g/cm³ |
| Tapped Bulk Density | 0.60 to 0.70 g/cm³ |
| Sulphur Dioxide | Max 50 ppm |
| Oxidising Substances | Negative (Ph. Eur., USPNF) |
| Organic Volatile Impurities | USP |
| Residual Solvent | Nil |
| Retention on 40 mesh | Max. 1% |
| Retention on 200 mesh | Min. 40% |
| Total Aerobic Microbial Count | Max. 1000 cfu/gm (Ph. Eur./USP) |
| Total Molds and Yeast Count | Max. 100 cfu/gm (Ph. Eur./USP) |
| E. Coli, Salmonella | Absent (Pharma Eur./USP) |