Pregelatinized Maize Starch (USP/BP, For Direct Compression)
Food
Code: 126095
commonly used in tablet formulations as a binder, disintegrant, and filler
Pregelatinized maize starch is commonly used in tablet formulations as a binder, disintegrant, and filler. Here’s how it functions in each role:
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Binder: Pregelatinized maize starch helps hold the ingredients of a tablet together, providing structural integrity. It promotes adhesion of powder particles, making the tablet strong and durable.
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Disintegrant: It assists in breaking down the tablet into smaller particles once ingested, which enhances the release and absorption of the active ingredients. Pregelatinized starch absorbs water and swells, causing the tablet to disintegrate.
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Filler: It can act as a diluent or filler in formulations where the active drug dose is low. Pregelatinized starch fills out the tablet and provides bulk.
Pregelatinized starch is especially useful in direct compression tablet formulations due to its free-flowing properties and compressibility, reducing the need for additional processing steps.
- Room (25-40C)
- 24 Months from manufacturing or testing date.
- Disperse in formulation. Heat tolerant.
- Heat Tolerant
- 0.00 - 0.00
- Dispersible in water, Dispersible in powder
- Oral Care
- -
| Test Name | Specification |
|---|---|
| Character | Meet requirements |
| Identification | Meet requirements |
| pH | 4.5 - 7.0 |
| Sulfur dioxide | Max 2.7 ml |
| Oxidizing Substances | Meet requirements |
| Loss on drying | Max 14% |
| Residue on Ignition | Max 0.5% |
| Iron | Max 20 ppm |
| Microbial limits | Standard |
| Aerobic bacteria | Max 1000 cfu/g |
| Mold and yeast | Max 100 cfu/g |
| Dioxan (ppm) | Max 10 |
| Salmonella | Not detected |
| E. Coli | Not detected |
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