Soluble Starch For Tablet Granulation (Modified Corn Starch)
modified corn starch to be suitable as a tablet granulating agent
Soluble Starch For Tablet Granulation (Modified Corn Starch)
modified corn starch to be suitable as a tablet granulating agent
Use: for excipient in tablet
Product characteristics: white powder
Solubility: Water soluble/dispersable
Storage: For long-term storage store at room temperature At least 2 years old
- 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
- -
| Test Name | Specification |
|---|---|
| Appearance | Should be white or off-white powder; soluble in boiling water, insoluble in water or ethanol |
| Identification (1) | Should conform |
| Identification (2) | Should give positive reaction |
| Iodine sensitivity | Should conform |
| Acidity | 6.0-7.5 |
| Reducing sugars | Not more than 0.25g |
| Clarity of solution | Should conform |
| Chlorides | Not more than 0.2% |
| Sulfates | Not more than 0.1% |
| Oxidizable substances | Not more than 0.002% |
| Loss on drying | Not more than 13.0% |
| Residue on ignition | Not more than 0.5% |
| Iron salts | Not more than 0.001% |
| Heavy metals | Not more than 20 ppm |
| Arsenic salts | Not more than 0.0002% |
| Microbial limits: Aerobic bacteria count | ≤10⁵ cfu/g |
| Microbial limits: Molds and yeasts count | ≤10⁴ cfu/g |
| Microbial limits: E. coli | Not detected |
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