Knowde Enhanced TDS
Identification & Functionality
- Chemical Family
- Technologies
Features & Benefits
- Labeling Claims
Applications & Uses
- Applications
- Dosage Form
- Food & Nutrition Applications
Properties
- Appearance
- White or almost white crystalline powder
- Soluble in
- Water, Ethanol (96%)
- Typical Properties
- Physico-Chemical Properties
- Microbiological Values
- Note
- (*) - Compliance data - Tests not performed
- (**) - Monitoring plan
| Value | Units | Test Method / Conditions | |
| Average Particle Size (Laser) | 300 | microns | — |
| Bulk Density | approx. 0.85 | kg/l | — |
| Conductivity | max. 20 | microS/cm | EP / USP-NF |
| Dextrin | Complies | — | EP / USP-NF |
| Identification Test A | Complies | — | EP |
| Identification Test A (*) | Complies | — | USP-NF |
| Identification Test B | Complies | — | EP / USP-NF |
| Identification Test C | Complies | — | USP-NF |
| Identification Test E | Complies | — | EP |
| Impurity C, Maltotriose | max. 0.2 | % | EP / USP-NF |
| Impurity D: Fructose | max. 0.15 | % | EP / USP-NF |
| Particle Size (min. 1000 microns) | max. 5 | % | — |
| Particle Size (min. 250 microns) | max. 70 | % | — |
| Particle Size (min. 40 microns) | min. 90 | % | — |
| Soluble Starch Sulfites | max. 15 | ppm | EP / USP-NF |
| Sum of Impurities A and B, Maltose and Isomaltose | max. 0.4 | % | EP / USP-NF |
| Total Impurities | max. 0.5 | % | — |
| Unspecified Impurities | max. 0.10 | % | EP / USP-NF |
| Water Content | max. 1.0 | % | EP / USP-NF |
| Value | Units | Test Method / Conditions | |
| Assay Content | 97.5 - 102.0 | % | EP / USP-NF |
| Value | Units | Test Method / Conditions | |
| Escherichia coli (**) | Not detected | per gram | — |
| Total Aerobic Microbial Count (**) | max. 1000 | CFU/g | — |
| Total Yeasts and Moulds Count (**) | max. 100 | CFU/g | — |
| Salmonella (**) | Not detected | per 10g | — |
Regulatory & Compliance
- Certifications & Compliance
- Grade
- Conformity
- Conforms to the requirements of the current monograph
- European Pharmacopeia (EP)
- US Pharmacopeia (USP) Please contact us for any statement regarding compliance to the General Chapters (elemental impurities, residual solvents, organic volatile impurities, metal catalyst, metal reagent).
Technical Details & Test Data
- Test Data
Methods used by Roquette may be the Pharmacopeia methods or alternative validated methods which have been compared to the Pharmacopeia methods.
Packaging & Availability
- Packaging Information
- ROQ Product Code: 361413
- Article (SKU) Code: 361413331G
- Package Size & Type: 25 kg paper bag
Storage & Handling
- Storage & Shelf Life
- Expiry date Manufacturing date + 5 years, in its unopened packaging.
- We recommend to preserve the product in its unopened original packaging, preferably protected from wide variations in temperature and humidity.