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PEARLITOL® 200 SD Mannitol - Pharma

PEARLITOL® Mannitol 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

Brand: PEARLITOL (11 products)

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: 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

Technical Data SheetSafety Data Sheet

Enhanced TDS

Knowde-enriched technical product data sheet

Identification & Functionality

Chemical Name
D-mannitol
Pharma & Nutraceuticals Functions
Binder,
Filler
CAS No.
87-78-5
EC No.
201-770-2
Technologies
Pharmaceuticals & Nutraceuticals
Product Families
Pharmaceuticals & Nutraceuticals — Excipients
Binders & Disintegrants,
Fillers & Diluents

Features & Benefits

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

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. 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 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

Certifications & Compliance
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)
Grade
Pharma Grade
Conformity

Conforms to the requirements of the current monograph

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

Technical Details & Test Data

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Packaging & Availability

Packaging Information
  • ROQ Product Code: 450320
  • Article (SKU) Code: 450320117
  • Package Size & Type: 25 kg polypropylene pail

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 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