PEARLITOL 200 SD Mannitol - Pharma - Roquette - 69-65-8

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

	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. 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 Sugars	max. 0.1	%	EP / USP / JP

	Value	Units	Test Method / Conditions
Escherichia coli (Monitoring plan)	Not detected	per gram	EP / USP
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: 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

Innovation Hub: Innovation Hub by Roquette

Looking for technical support or formulation inspiration? Visit Roquette’s Innovation Hub.

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

PEARLITOL® 200 SD Mannitol - Pharma