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PEARLITOL® 50 C Mannitol - Pharma

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PEARLITOL® 50 C Mannitol - Pharma

PEARLITOL® Mannitol pharma range is used as a filler and filler/binder as well as a bulk sweetener. The PEARLITOL® range offers a unique blend of exceptional physical and chemical stability and no hygroscopicity. Using different texturizing technologies we have designed a crystalline range of directly compressible PEARLITOL® (SD, DC and C) with various particle size allowing you to find the right product. With great organoleptic, non-cariogenic and sugar-free properties PEARLITOL® is suitable to be used in formulation addressing all type of patient population including pediatric and diabetic. PEARLITOL® can be used in in various oral dosage forms in both pharmaceutical and nutraceutical applications including swallowable tablets, orally dispersible tablets, chewable tablets, effervescent tablets, lozenges, blends, granules, pellets premix and medicated confectionary.
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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 crystalline 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. 100 micron)max. 25%Laser
Particle Size Part (min. 20 micron)max. 55%Laser
Particle Size Part (min. 250 micron)max. 5%Laser
Reducing Sugarsmax. 0.1%EP / USP / JP
Microbiological Values
ValueUnitsTest Method / Conditions
Escherichia Coli (Monitoring plan)Not detected in 1g-EP / USP
Escherichia Coli (Monitoring plan)Not Detected1gEP / USP
Salmonella Species (Monitoring plan)Not detected in 10g-EP
SalmonellaNot Detected10gEP
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: 22.68 kg lined fiber drum

Storage & Handling

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Shelf Life
3 Years

Most Viewed Documents

View All 24 Documents

Document Name
Type
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Roquette Quality Certification HALAL MUI Pantnagar - EN
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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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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® 50C Technical Data Sheet
Technical Data Sheet
PEARLITOL® 50 C Mannitol - Pharma
Technical Data Sheet
Products: PEARLITOL® 50 C 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
Roquette Quality Certification HALAL Wuhan
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
Roquette Quality Certification HALAL JUHF 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
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
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