PEARLITOL® 50 C Mannitol - Pharma

1 of 13 products in this brand

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

Applications

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

Benefit

  • Suitable for use in formulations addressing all types of patient populations, including pediatric and diabetic

Features

  • Directly compressible
  • Unique blend of exceptional physical and chemical stability
  • No hygroscopicity
  • Organoleptic, non-cariogenic and sugar-free properties

Chemical Name: Mannitol

Functions: Binder, Filler, Sweetener

CAS Number: 87-78-5

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

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

Synonyms: 1,2,3,4,5,6-Hexanehexol, Cordycepic Acid, Manicol, Manitol

Knowde Enhanced TDS

Identification & Functionality

Chemical Name
Pharma & Nutraceuticals Functions
CAS No.
87-78-5
EC No.
201-770-2

Features & Benefits

Applications & Uses

Manufacturing Technology

Properties

Physical Form
Appearance
White or almost white crystalline 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. 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 Detectedper gramEP / USP
SalmonellaNot Detectedper 10gEP
Salmonella Species (Monitoring plan)Not detectedper 10gEP
Total Aerobic Microbial Countmax. 1000CFU/gEP / USP
Total Yeasts and Moulds Countmax. 100CFU/gEP / USP

Regulatory & Compliance

Chemical Inventories

Technical Details & Test Data

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Packaging & Availability

Packaging Information
  • ROQ Product Code: 450310
  • Article (SKU) Code: 450310105
  • Package Size & Type: 22.68 kg lined fiber drum

Storage & Handling

Shelf Life
3 Years