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PEARLITOL® 100 SD Mannitol - Pharma

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PEARLITOL® 100 SD Mannitol - Pharma

PEARLITOL® Mannitol pharma range is used in pharmaceutical and nutraceutical formulations as a filler, filler/binder and bulk sweetener in oral dosage form applications.

Applications

  • Swallowable,  orally dispersible, chewable and effervescent tablets
  • Lozenges
  • Blends
  • Granules
  • Pellets premix
  • Medicated confectionery

Features

  • Unique blend of exceptional physical and chemical stability and no hygroscopicity
  • Directly compressible crystalline range with various particle sizes
  • Great organoleptic, non-cariogenic and sugar-free properties
  • Suitable for use in formulations addressing pediatric and diabetic patient populations
Product Resources

Experts

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Knowde Enhanced TDS

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Identification & Functionality

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Features & Benefits

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Applications & Uses

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Properties

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Physical Form
Color
White
Appearance
White or almost white crystals or powder
Soluble in
Water
Insoluble in
Ethanol
Typical Properties
ValueUnitsTest Method / Conditions
Conductivitymax. 20microS/cmEP / USP / JP
D-Mannitol (on DS)97.0 - 102.0%EP / USP / JP
Heavy Metals Content (Monitoring plan)max. 5mg/kgJP
Loss on Dryingmax. 0.5%EP / USP / JP
Melting Point165 - 170°CEP / USP / JP
Nickel Content (Monitoring plan)max. 1mg/kgUSP / JP
Particle Size Part (min. 140 micron Sympatec)max. 35%Laser
Particle Size Part (min. 150 micron Beckman)max. 35%Laser
Particle Size Part (min. 30 micron Sympatec)max. 70%Laser
Particle Size Part (min. 75 micron Beckman)max. 70%Laser
Reducing Sugarsmax. 0.1%EP / USP / JP
Microbiological Values
ValueUnitsTest Method / Conditions
Escherichia Coli (Monitoring plan)Not detected in 1g-EP / USP
Salmonella Species (Monitoring plan)Not detected in 10g-EP
Total Aerobic Microbial Countmax. 1000CFU/gEP / USP
Total Yeasts and Moulds Countmax. 100CFU/gEP / USP

Regulatory & Compliance

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Technical Details & Test Data

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Innovation Hub
Innovation Hub by Roquette
Looking for technical support or formulation inspiration? Visit Roquette’s Innovation Hub.

Packaging & Availability

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Packaging Information
  • ROQ Product Code: 450310
  • Article (SKU) Code: 450310105
  • Package Size & Type: 20 kg lined cardboard box

Storage & Handling

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Shelf Life
5 Years
Storage and Handling

Expiry date Manufacturing date + 5 years, in its unopened packaging.The product durability may vary according to packaging type and manufacturing plant. Proper information is shown on labelling and CoA.We recommend to preserve the product in its unopened original packaging, preferably protected from wide variations of temperature and humidity.Upon opening, use the product as quickly as possible to prevent moisture regain.

Most Viewed Documents

View All 22 Documents

Document Name
Type
Products
Learn More
PEARLITOL® 100 SD Technical Data Sheet
Technical Data Sheet
PEARLITOL® 100 SD Mannitol - Pharma
Technical Data Sheet
Products: PEARLITOL® 100 SD Mannitol - Pharma
PEARLITOL® 100 SD Safety Data Sheet (REC - EN)
Safety Data Sheet
PEARLITOL® 100 SD Mannitol - Pharma
Safety Data Sheet
Products: PEARLITOL® 100 SD Mannitol - Pharma
Roquette Quality Certification HALAL MUI Pantnagar - EN
Other
XYLISORB XTAB® 240 Xylitol - Pharma, KLEPTOSE® HPB Oral Grade Hydroxyprpyl Betadex - Pharma, KLEPTOSE® HPB Parenteral Grade Hydroxypropyl Betadex, MICROCEL® MC-101 Microcrystalline Cellulose - Pharma, MICROCEL® MC-102 Microcrystalline Cellulose - Pharma, SOLUTAB® A Croscarmellose Sodium - Pharma, PEARLITOL® 50 C Mannitol - Pharma, LYCATAB® C Partially Pregalatinized Starch - Pharma, LYCATAB® PGS Pregelatinized Starch - Pharma, PEARLITOL® 100 SD Mannitol - Pharma, PEARLITOL® 200 SD Mannitol - Pharma, PEARLITOL® 300 DC Mannitol - Pharma
Other
Products: XYLISORB XTAB® 240 Xylitol - Pharma, KLEPTOSE® HPB Oral Grade Hydroxyprpyl Betadex - Pharma, KLEPTOSE® HPB Parenteral Grade Hydroxypropyl Betadex, MICROCEL® MC-101 Microcrystalline Cellulose - Pharma, MICROCEL® MC-102 Microcrystalline Cellulose - Pharma, SOLUTAB® A Croscarmellose Sodium - Pharma, PEARLITOL® 50 C Mannitol - Pharma, LYCATAB® C Partially Pregalatinized Starch - Pharma, LYCATAB® PGS Pregelatinized Starch - Pharma, PEARLITOL® 100 SD Mannitol - Pharma, PEARLITOL® 200 SD Mannitol - Pharma, PEARLITOL® 300 DC Mannitol - Pharma
PEARLITOL® 100 SD Safety Data Sheet (REC - ES)
Safety Data Sheet
PEARLITOL® 100 SD Mannitol - Pharma
Safety Data Sheet
Products: PEARLITOL® 100 SD Mannitol - Pharma
Roquette Quality Information Note Contaminant Others Melamine - EN
Other
XYLISORB XTAB® 240 Xylitol - Pharma, KLEPTOSE® HPB Oral Grade Hydroxyprpyl Betadex - Pharma, KLEPTOSE® HPB Parenteral Grade Hydroxypropyl Betadex, PEARLITOL® 50 C Mannitol - Pharma, LYCATAB® C Partially Pregalatinized Starch - Pharma, LYCATAB® PGS Pregelatinized Starch - Pharma, PEARLITOL® 100 SD Mannitol - Pharma, PEARLITOL® 200 SD Mannitol - Pharma, PEARLITOL® 300 DC Mannitol - Pharma
Other
Products: XYLISORB XTAB® 240 Xylitol - Pharma, KLEPTOSE® HPB Oral Grade Hydroxyprpyl Betadex - Pharma, KLEPTOSE® HPB Parenteral Grade Hydroxypropyl Betadex, PEARLITOL® 50 C Mannitol - Pharma, LYCATAB® C Partially Pregalatinized Starch - Pharma, LYCATAB® PGS Pregelatinized Starch - Pharma, PEARLITOL® 100 SD Mannitol - Pharma, PEARLITOL® 200 SD Mannitol - Pharma, PEARLITOL® 300 DC Mannitol - Pharma
Roquette Quality Certification ISO 9001 Gokak - EN
Other
XYLISORB XTAB® 240 Xylitol - Pharma, KLEPTOSE® HPB Oral Grade Hydroxyprpyl Betadex - Pharma, KLEPTOSE® HPB Parenteral Grade Hydroxypropyl Betadex, MICROCEL® MC-101 Microcrystalline Cellulose - Pharma, MICROCEL® MC-102 Microcrystalline Cellulose - Pharma, SOLUTAB® A Croscarmellose Sodium - Pharma, PEARLITOL® 50 C Mannitol - Pharma, LYCATAB® C Partially Pregalatinized Starch - Pharma, LYCATAB® PGS Pregelatinized Starch - Pharma, PEARLITOL® 100 SD Mannitol - Pharma, PEARLITOL® 200 SD Mannitol - Pharma, PEARLITOL® 300 DC Mannitol - Pharma
Other
Products: XYLISORB XTAB® 240 Xylitol - Pharma, KLEPTOSE® HPB Oral Grade Hydroxyprpyl Betadex - Pharma, KLEPTOSE® HPB Parenteral Grade Hydroxypropyl Betadex, MICROCEL® MC-101 Microcrystalline Cellulose - Pharma, MICROCEL® MC-102 Microcrystalline Cellulose - Pharma, SOLUTAB® A Croscarmellose Sodium - Pharma, PEARLITOL® 50 C Mannitol - Pharma, LYCATAB® C Partially Pregalatinized Starch - Pharma, LYCATAB® PGS Pregelatinized Starch - Pharma, PEARLITOL® 100 SD Mannitol - Pharma, PEARLITOL® 200 SD Mannitol - Pharma, PEARLITOL® 300 DC Mannitol - Pharma
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