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PEARLITOL® Flash Mannitol - Pharma

PEARLITOL® Flash is used in nutraceutical and pharma oral dosage forms as a filler/binder for orally dispersable tablets. Applications Fast disintegrating tablets Orally dispersible tablets Benefits Excipient functional properties Disintegrant benefit Simplifies tablet formulation Features Compound of mannitol and starch adapted to direct compression formulation Excellent chemical inertness Consistent rapid disintegration under any compression force

Brand: PEARLITOL (13 products)

Functions: Binder, Disintegrant, Filler

Dosage Form: Orally Disintegrating Tablets (ODTs), Tablets

Labeling Claims: BSE-free, Halal, Kosher, Melamine-free, Non-GMO, Non-Hazardous, TSE-free, Vegan

Certifications & Compliance: EXCiPACT, European Pharmacopeia (Ph. Eur.), FDA Compliant, GMP, Halal, ISO 50001, ISO 9001, Japan Pharmacopeia (JP), Kosher, United States Pharmacopeia (USP)

Enhanced TDS

Enhanced TDS

Knowde-enriched technical product data sheet

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

Roquette PEARLITOL Flash Mannitol, Pharma Chemical Structure

Features & Benefits

Applications & Uses

Markets
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

Physical Form
Odor
Neutral
Taste
Sweet
Appearance
White powder
Soluble in
Water
Insoluble in
Ethanol (96%)
Typical Properties
ValueUnitsTest Method / Conditions
Average Mean Particle Diameter200µm-
Melting Temperature (for D-Mannitol)166 - 170°C-
Molecular Weight (Mannitol)182.17g/mol-
Particle Size Distribution by Laser Diffraction (dv10)80µm-
Particle Size Distribution by Laser Diffraction (dv50)200µm-
Particle Size Distribution by Laser Diffraction (dv90)300µm-
Water Content (LOD)max. 3%-
Physico-Chemical Properties
ValueUnitsTest Method / Conditions
D-mannitol /Com.78.0 - 82.0%-
Iron Content (*)max. 10ppm-
Lead Contentmax. 0.5ppm-
Loss on Dryingmax. 3.0%-
Maize Starch (on DS)15.0 - 19.0%-
Nickel Content (*)max. 1ppm-
Oxidising Substances (*)max. 20ppm-
Sulfated Ash Contentmax. 0.2%-
Sulfur Dioxide Contentmax. 10ppm-
Particle Size (Residue on 100 microns)min. 80%-
Particle Size (Residue on 315 microns)max. 20%-
Microbiological Values
ValueUnitsTest Method / Conditions
Escherichia coli (**)Absentper 10g-
Salmonella (**)Absentper 10g-
Total Aerobic Microbial Countmax. 1000CFU/gPlate count
Total Yeasts and Moulds Countmax. 100CFU/g-
Powder Characteristics
ValueUnitsTest Method / Conditions
Powder Flowability5Saccording to Ph.Eur. 2.9.16, 10mm outflow opening
Bulk Density0.52g/cm3
Tapped Density0.65g/cm3
True Density1.503g/cm3
Specific Surface Area0.55m²/g
Angle of Repose40°
Note
  • * - Compliance data - Tests not performed
  • ** - Monitoring plan
Quantitative Composition
Approximately D-Mannitol 80%-Extra White Maize Starch 20%

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

Roquette PEARLITOL Flash Mannitol, Pharma 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

Roquette PEARLITOL Flash Mannitol, Pharma Water Sorption Isotherm at 20°C

Compression Behavior

Roquette PEARLITOL Flash Mannitol, Pharma Compression Behavior

Innovation Hub
Innovation Hub by Roquette
Looking 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.