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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

Technical Data SheetSafety Data Sheet

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Identification & Functionality

Chemical Name

Mannitol

Pharma & Nutraceuticals Functions

Binder,

Filler,

Sweetener

CAS No.
87-78-5
EC No.
201-770-2
Technologies

Pharmaceuticals & Nutraceuticals

Product Families

Pharmaceuticals & Nutraceuticals — Excipients

Binders & Disintegrants,

Fillers & Diluents,

Flavors & Taste Maskers

Features & Benefits

Labeling Claims

Acrylamide-free,

Halal,

Kosher,

Melamine-free,

Non-Carcinogenic,

Sugar-free,

Vegan

Applications & Uses

Markets

Healthcare & Pharma

Applications

Healthcare & Pharma — Drug Delivery & Care Solutions

Oral

Dosage Form

Capsules,

Granules,

Orally Disintegrating Tablets (ODTs),

Powder & Powder Blends,

Tablets

Manufacturing Technology

Direct Compression

Properties

Physical Form

Powder,

Solid

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

Certifications & Compliance

DMF Type II,

European Pharmacopeia (Ph. Eur.),

FDA IID,

FSSAI,

FSSC 22000,

Halal,

ISO 9001,

Japan Pharmacopeia (JP),

Kosher,

United States Pharmacopeia (USP)

Chemical Inventories

TSCA (USA)

Grade

Pharma Grade

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