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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
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
Salmonella Species (Monitoring plan)Not detected in 10g-EP
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

Regulatory & Compliance

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Storage & Handling

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Shelf Life
3 Years

Documents (24)

Document Name
Type
Products
Technical Data Sheet
PEARLITOL® 50 C Mannitol - Pharma
Technical Data Sheet
Products: PEARLITOL® 50 C Mannitol - Pharma
Safety Data Sheet
PEARLITOL® 50 C Mannitol - Pharma
Safety Data Sheet
Products: PEARLITOL® 50 C Mannitol - Pharma
Safety Data Sheet
PEARLITOL® 50 C Mannitol - Pharma
Safety Data Sheet
Products: PEARLITOL® 50 C Mannitol - Pharma
Safety Data Sheet
PEARLITOL® 50 C Mannitol - Pharma
Safety Data Sheet
Products: PEARLITOL® 50 C Mannitol - Pharma
Safety Data Sheet
PEARLITOL® 50 C Mannitol - Pharma
Safety Data Sheet
Products: PEARLITOL® 50 C Mannitol - Pharma