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PEARLITOL® 50 C Mannitol - Pharma

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

Brand: PEARLITOL (10 products)

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 Sheet Safety Data Sheet

Enhanced TDS

Knowde-enriched technical product data sheet

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

Appearance

White or almost white crystalline powder

Soluble in

Very soluble in water (216 mg/ml at 25°C)

Insoluble in

Practically insoluble in ethanol

Typical Properties


	Value	Units	Test Method / Conditions
Conductivity	max. 20	microS/cm	EP / USP / JP
D-Mannitol (on DS)	97.0 - 102.0	%	EP / USP / JP
Heavy Metals Content (Monitoring plan)	max. 5	mg/kg	JP
Loss on Drying	max. 0.5	%	EP / USP / JP
Melting Point	165 - 170	°C	EP / USP / JP
Nickel Content (Monitoring plan)	max. 1	mg/kg	USP / 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 Sugars	max. 0.1	%	EP / USP / JP

Microbiological Values


	Value	Units	Test Method / Conditions
Escherichia coli (Monitoring plan)	Not Detected	per gram	EP / USP
Salmonella	Not Detected	per 10g	EP
Salmonella Species (Monitoring plan)	Not detected	per 10g	EP
Total Aerobic Microbial Count	max. 1000	CFU/g	EP / USP
Total Yeasts and Moulds Count	max. 100	CFU/g	EP / 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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Looking for technical support or formulation inspiration? Visit Roquette’s Innovation Hub.

Packaging & Availability

Packaging Information

Article (SKU) Code: 5100001108
Package Size & Type: 50 KG POWDER DRUM

Storage & Handling

Shelf Life: 3 Years