PEARLITOL® 300 DC Mannitol - Pharma

1 of 13 products in this brand
PEARLITOL® Mannitol pharma range is used in pharmaceutical and nutraceutical formulations as a filler, filler/binder and bulk sweetener in various oral dosage 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: D-mannitol

CAS Number: 69-65-8

Functions: Binder, Filler

Dosage Form: Capsules, Granules, Orally Disintegrating Tablets (ODTs), Powder & Powder Blends, Tablets

Labeling Claims: Acrylamide-free, BSE-free, Halal, Kosher, Melamine-free, Non-Carcinogenic, Non-GMO, Sugar-free, TSE-free, Vegan

Certifications & Compliance: Canadian Environmental Protection Act (CEPA), Chinese Pharmacopeia (ChP), EXCiPACT, European Pharmacopeia (Ph. Eur.), FDA IID, FSSAI, FSSC 22000, GMP, Halal, ISO 9001, Japan Pharmacopeia (JP), Kosher, United States Pharmacopeia (USP)

Synonyms: 1,2,3,4,5,6-Hexanehexol, Cordycepic Acid, D-(-)-Mannitol, Manicol, Manitol

Knowde Enhanced TDS

Identification & Functionality

Chemical Name
Pharma & Nutraceuticals Functions
EC No.

Features & Benefits

Applications & Uses

Manufacturing Technology


Physical Form
White or almost white crystalline powder
Soluble in
Insoluble in
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 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

Packaging & Availability

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

Storage & Handling

Shelf Life
5 Years
Storage and Handling

The product durability may vary according to packaging type and manufacturing plant. Proper information is shown on labeling 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.