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PEARLITOL® Flash Mannitol - Pharma

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Chemical Name: Corn Starch, Mannitol
Function: Filler, Disintegrant, Binder
Certifications & Compliance: Halal, EXCiPACT, United States Pharmacopeia (USP), ISO 9001, Japan Pharmacopeia (JP), GMP, Kosher, FDA Approved, ISO 50001, European Pharmacopeia (Ph. Eur.)
Labeling Claims: Halal, Kosher, Non-Hazardous, Non-GMO, BSE-free, Vegan, Melamine-free, TSE-free
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TypeDocument Name
Safety Data Sheet
PEARLITOL® Flash Mannitol, Pharma - Portuguese Safety Data Sheet
PEARLITOL® Flash Mannitol, Pharma - Portuguese Safety Data Sheet
Safety Data Sheet
Safety Data Sheet
PEARLITOL® Flash Mannitol, Pharma - Spanish Safety Data Sheet
PEARLITOL® Flash Mannitol, Pharma - Spanish Safety Data Sheet
Safety Data Sheet
Safety Data Sheet
PEARLITOL® Flash Mannitol, Pharma Safety Data Sheet
PEARLITOL® Flash Mannitol, Pharma Safety Data Sheet
Safety Data Sheet
Technical Data Sheet
PEARLITOL® Flash Mannitol, Pharma Technical Data Sheet
PEARLITOL® Flash Mannitol, Pharma Technical Data Sheet
Technical Data Sheet

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Identification & Functionality

Chemical Structure

Roquette PEARLITOL Flash Mannitol, Pharma Chemical Structure

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 Pharmacopoeia methods or internal validated methods which have been compared to the Pharmacopoeia methods.

PEARLITOL® Flash Mannitol - Pharma Features & Benefits

Applications & Uses

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°-
Quantitative Composition
Approximately D-Mannitol 80%-Extra White Maize Starch 20%
Note
  • * - Compliance data - Tests not performed
  • ** - Monitoring plan

Regulatory & Compliance

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 Pharmacopoeias (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

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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.
PEARLITOL® Flash Mannitol - Pharma
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