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PEARLITOL® 100 SD Mannitol - Pharma

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PEARLITOL® Mannitol pharma range is used in pharmaceutical and nutraceutical formulations as a filler, filler/binder and bulk sweetener in oral dosage form applications.

Applications

  • Swallowable,  orally dispersible, chewable and effervescent tablets
  • Lozenges
  • Blends
  • Granules
  • Pellets premix
  • Medicated confectionery

Features

  • Unique blend of exceptional physical and chemical stability and no hygroscopicity
  • Directly compressible crystalline range with various particle sizes
  • Great organoleptic, non-cariogenic and sugar-free properties
  • Suitable for use in formulations addressing pediatric and diabetic patient populations
Chemical Name: Mannitol
Function: Filler, Binder
Certifications & Compliance: EXCiPACT, United States Pharmacopeia (USP), ISO 9001, Japan Pharmacopeia (JP), GMP, FDA IID, Kosher, European Pharmacopeia (Ph. Eur.), Chinese Pharmacopeia (ChP), Halal
Labeling Claims: Halal, Kosher, Non-GMO, BSE-free, Vegan, TSE-free, Acrylamide-free
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Identification & Functionality

PEARLITOL® 100 SD Mannitol - Pharma Features & Benefits

Applications & Uses

Properties

Physical Form
Appearance
White or almost white crystals or 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. 140 micron Sympatec)max. 35%Laser
Particle Size Part (min. 150 micron Beckman)max. 35%Laser
Particle Size Part (min. 30 micron Sympatec)max. 70%Laser
Particle Size Part (min. 75 micron Beckman)max. 70%Laser
Reducing Sugarsmax. 0.1%EP / USP / JP
Microbiological Values
ValueUnitsTest Method / Conditions
Escherichia coli (Monitoring plan)Not detectedper gramEP / USP
Salmonella Species (Monitoring plan)Not detectedper 10gEP
Total Aerobic Microbial Countmax. 1000CFU/gEP / USP
Total Yeasts and Moulds Countmax. 100CFU/gEP / USP

Regulatory & Compliance

Technical Details & Test Data

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Packaging & Availability

Packaging Information
  • ROQ Product Code: 450310
  • Article (SKU) Code: 450310105
  • Package Size & Type: 20 kg lined cardboard box

Storage & Handling

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.

Most Viewed Documents

Document Name
Type
Products
PEARLITOL® 100 SD Technical Data Sheet
Technical Data Sheet
PEARLITOL® 100 SD Mannitol - Pharma
Technical Data Sheet
Products: PEARLITOL® 100 SD Mannitol - Pharma
PEARLITOL® 100 SD Safety Data Sheet (REC - EN)
Safety Data Sheet
PEARLITOL® 100 SD Mannitol - Pharma
Safety Data Sheet
Products: PEARLITOL® 100 SD Mannitol - Pharma
PEARLITOL® 100 SD Safety Data Sheet (REC - ES)
Safety Data Sheet
PEARLITOL® 100 SD Mannitol - Pharma
Safety Data Sheet
Products: PEARLITOL® 100 SD Mannitol - Pharma
PEARLITOL® 100 SD Safety Data Sheet (US - EN)
Safety Data Sheet
PEARLITOL® 100 SD Mannitol - Pharma
Safety Data Sheet
Products: PEARLITOL® 100 SD Mannitol - Pharma
PEARLITOL® 100 SD Safety Data Sheet (REC - PT)
Safety Data Sheet
PEARLITOL® 100 SD Mannitol - Pharma
Safety Data Sheet
Products: PEARLITOL® 100 SD Mannitol - Pharma