Knowde Enhanced TDS
Identification & Functionality
- Chemical Family
- Pharma & Nutraceuticals Functions
- EINECS No.
- 200-711-8, 232-679-6
- Technologies
- Product Families
- Identification
- MANNITOL Retention time of HPLC peak. identification test 1 and 2 (JP)
- MAIZE STARCH identification test A (EP/USP)
- Identification test C (EP/USP) identification test 1, 2 and 3 (JP) Methods used by Roquette may be the Pharmacopeia methods or internal validated methods which have been compared to the Pharmacopeia methods.
- Chemical Structure
Features & Benefits
- Benefit Claims
Applications & Uses
- Applications
- Dosage Form
- Manufacturing Technology
- Application
- PEARLITOL® Flash is a direct compression excipient with disintegrant properties. It offers excellent chemical inertness and consistent rapid disintegration time. It brings a pleasant taste and texture and is suitable for swallowable and orally dispersible tablets.
Properties
- Odor
- Neutral
- Taste
- Sweet
- Appearance
- White powder
- Soluble in
- Water
- Insoluble in
- Ethanol (96%)
- Typical Properties
- Physico-Chemical Properties
- Microbiological Values
- Powder Characteristics
- Note
- * - Compliance data - Tests not performed
- ** - Monitoring plan
- Quantitative Composition
- Approximately D-Mannitol 80%-Extra White Maize Starch 20%
| Value | Units | Test Method / Conditions | |
| Average Mean Particle Diameter | 200 | µm | — |
| Melting Temperature (for D-Mannitol) | 166 - 170 | °C | — |
| Molecular Weight (Mannitol) | 182.17 | g/mol | — |
| Particle Size Distribution by Laser Diffraction (dv10) | 80 | µm | — |
| Particle Size Distribution by Laser Diffraction (dv50) | 200 | µm | — |
| Particle Size Distribution by Laser Diffraction (dv90) | 300 | µm | — |
| Water Content (LOD) | max. 3 | % | — |
| Value | Units | Test Method / Conditions | |
| D-mannitol /Com. | 78.0 - 82.0 | % | — |
| Iron Content (*) | max. 10 | ppm | — |
| Lead Content | max. 0.5 | ppm | — |
| Loss on Drying | max. 3.0 | % | — |
| Maize Starch (on DS) | 15.0 - 19.0 | % | — |
| Nickel Content (*) | max. 1 | ppm | — |
| Oxidising Substances (*) | max. 20 | ppm | — |
| Sulfated Ash Content | max. 0.2 | % | — |
| Sulfur Dioxide Content | max. 10 | ppm | — |
| Particle Size (Residue on 100 microns) | min. 80 | % | — |
| Particle Size (Residue on 315 microns) | max. 20 | % | — |
| Value | Units | Test Method / Conditions | |
| Escherichia coli (**) | Absent | per 10g | — |
| Salmonella (**) | Absent | per 10g | — |
| Total Aerobic Microbial Count | max. 1000 | CFU/g | Plate count |
| Total Yeasts and Moulds Count | max. 100 | CFU/g | — |
| Value | Units | Test Method / Conditions | |
| Powder Flowability | 5 | S | according to Ph.Eur. 2.9.16, 10mm outflow opening |
| Bulk Density | 0.52 | g/cm3 | — |
| Tapped Density | 0.65 | g/cm3 | — |
| True Density | 1.503 | g/cm3 | — |
| Specific Surface Area | 0.55 | m²/g | — |
| Angle of Repose | 40 | ° | — |
Regulatory & Compliance
- Certifications & Compliance
- Chemical Inventories
- Grade
- Current pharmacopeias
- MANNITOL EP - USP/NF - JP
- MAIZE STARCH EP - USP/NF - JP
- PEARLITOL FLASH JPE 2018 Regarding any compliance referred to in the General Chapters of the Pharmacopeias (elemental impurities, residual solvents, organic volatile impurities, metal catalyst, metal reagent), statements are available on request.
Technical Details & Test Data
- Morphology
- Experimental Conditions for Compression Behavior
Tablet Press STYLCAM 200R Production Speed 10 tabs/min (Linear punch velocity: 38 mm/s ; Simulated rotary press speed: 60000 tablets/hour) Tooling 10 mm Flat Lubrication 1.2% Magnesium stearate - Water Sorption Isotherm at 20°C
- Compression Behavior
- Innovation Hub
- Innovation Hub by RoquetteLooking for technical support or formulation inspiration? Visit Roquette’s Innovation Hub.
Packaging & Availability
- Packaging Information
- ROQ Product Code: 401006
- Article (SKU) Code: 401006103J
- Package Size & Type: 20 kg polypropylene pail
Storage & Handling
- Storage & Shelf Life
- Manufacturing date + 3 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.