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PEARLITOL® 300 DC Mannitol - Pharma

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Chemical Name: D-mannitol
Function: Filler, Binder
CAS Number: 69-65-8
Dosage Form: Capsules, Orally Disintegrating Tablets (ODTs), Powder & Powder Blends, Tablets, Granules
Labeling Claims: Melamine-free, Kosher, Vegan, BSE-free, Halal, Sugar-free, Non-Carcinogenic, TSE-free, Non-GMO, Acrylamide-free
Certifications & Compliance: FSSAI, United States Pharmacopeia (USP), European Pharmacopeia (Ph. Eur.), Japan Pharmacopeia (JP), ISO 9001, FDA IID, EXCiPACT, Kosher, Chinese Pharmacopeia (ChP), Halal, Canadian Environmental Protection Act (CEPA), FSSC 22000, GMP
Synonyms: Manitol, Cordycepic Acid, D-(-)-Mannitol, Manicol, 1,2,3,4,5,6-Hexanehexol
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TypeDocument Name
Technical Data Sheet
PEARLITOL® 300 DC Technical Data Sheet
PEARLITOL® 300 DC Technical Data Sheet
Technical Data Sheet
Safety Data Sheet
PEARLITOL® 300 DC Mannitol - Pharma Safety Data Sheet (REC - EN)
PEARLITOL® 300 DC Mannitol - Pharma Safety Data Sheet (REC - EN)
Safety Data Sheet
Safety Data Sheet
PEARLITOL® 300 DC Mannitol - Pharma Safety Data Sheet (REC - PT)
PEARLITOL® 300 DC Mannitol - Pharma Safety Data Sheet (REC - PT)
Safety Data Sheet
Safety Data Sheet
PEARLITOL® 300 DC Mannitol - Pharma Safety Data Sheet (REC - ES)
PEARLITOL® 300 DC Mannitol - Pharma Safety Data Sheet (REC - ES)
Safety Data Sheet
Safety Data Sheet
PEARLITOL® 300 DC Mannitol - Pharma Safety Data Sheet (US - EN)
PEARLITOL® 300 DC Mannitol - Pharma Safety Data Sheet (US - EN)
Safety Data Sheet

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Identification & Functionality

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

PEARLITOL® 300 DC Mannitol - Pharma Features & Benefits

Applications & Uses

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. 200 micron)max. 70%Sieve
Particle Size Part (min. 315 micron)max. 55%Sieve
Particle Size Part (min. 500 micron)max. 0.5%Sieve
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

Packaging & Availability

Packaging Information
  • ROQ Product Code: 450108
  • Article (SKU) Code: 450108101
  • Package Size & Type: 50 kg lined fiber drum

Storage & Handling

Shelf Life
5 Years
Storage and Handling

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® 300 DC Mannitol - Pharma
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