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PEARLITOL® 300 DC Mannitol - Pharma

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PEARLITOL® 300 DC 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. 200 micron)max. 70%Sieve
Particle Size Part (min. 315 micron)max. 55%Sieve
Particle Size Part (min. 500 micron)max. 0.5%Sieve
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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Packaging & Availability

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Packaging Information
  • ROQ Product Code: 450108
  • Article (SKU) Code: 450108101
  • Package Size & Type: 50 kg lined fiber drum

Storage & Handling

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Shelf Life
5 Years
Storage and Handling

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

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Document Name
Type
Products
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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
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® 300 DC Technical Data Sheet
Technical Data Sheet
PEARLITOL® 300 DC Mannitol - Pharma
Technical Data Sheet
Products: PEARLITOL® 300 DC Mannitol - Pharma
PEARLITOL® 300 DC Safety Data Sheet (REC - EN)
Safety Data Sheet
PEARLITOL® 300 DC Mannitol - Pharma
Safety Data Sheet
Products: 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 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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