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PEARLITOL® 200 SD Mannitol - Pharma
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PEARLITOL® 200 SD 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.
Product Resources

Experts (2)

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
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. 45%Laser
Particle Size Part (min. 150 micron Beckman)max. 45%Laser
Particle Size Part (min. 30 micron Sympatec)max. 90%Laser
Particle Size Part (min. 300 micron Sympatec)max. 10%Laser
Particle Size Part (min. 315 micron Beckman)max. 10%Laser
Particle Size Part (min. 75 micron Beckman)max. 90%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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Conformity

Conforms to the requirements of the current monograph

  • European Pharmacopoeia (EP) MANNITOL (0559) 
  • US Pharmacopeia (USP) MANNITOL 
  • Japanese Pharmacopoeia (JP) D-MANNITOL

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

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Documents (22)

Document Name
Type
Products
Technical Data Sheet
PEARLITOL® 200 SD Mannitol - Pharma
Technical Data Sheet
Products: PEARLITOL® 200 SD Mannitol - Pharma
Safety Data Sheet
PEARLITOL® 200 SD Mannitol - Pharma
Safety Data Sheet
Products: PEARLITOL® 200 SD Mannitol - Pharma
Safety Data Sheet
PEARLITOL® 200 SD Mannitol - Pharma
Safety Data Sheet
Products: PEARLITOL® 200 SD Mannitol - Pharma
Safety Data Sheet
PEARLITOL® 200 SD Mannitol - Pharma
Safety Data Sheet
Products: PEARLITOL® 200 SD Mannitol - Pharma
Safety Data Sheet
PEARLITOL® 200 SD Mannitol - Pharma
Safety Data Sheet
Products: PEARLITOL® 200 SD Mannitol - Pharma