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PEARLITOL® 50 C Mannitol
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Producer: 
Roquette
Brand: 
PEARLITOL
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.

PEARLITOL® 50 C Mannitol

Producer: 
Roquette
Brand: 
PEARLITOL
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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Properties

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Physical Form
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 1gEP / USP
Salmonella Species (Monitoring plan)Not detected in 10gEP
Total Aerobic Microbial Countmax. 1000CFU/gEP / USP
Total Yeasts and Moulds Countmax. 100CFU/gEP / USP
Color
White
Physical Form
Powder
Appearance
White or almost white crystalline powder
Soluble in
Water
Insoluble in
Ethanol

Storage & Handling

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Shelf Life
3 Years

Documents (24)

Name
Type
Roquette Quality Certification FDA Americas - EN
Other
Roquette Quality Information Note Contaminant Others Melamine - EN
Other
Roquette Quality Information Note Contaminants and Pesticides Raw Material USA - EN
Other
Roquette Quality Information Note Contaminants Others ACRYLAMIDE USA - EN
Other
Roquette Quality Certification Drug Establishment Registration LYCADEX PF Keokuk - EN
Other