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PEARLITOL® 100 SD 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), Tablets
Labeling Claims: Kosher, BSE-free, Vegan, Halal, TSE-free, Non-GMO, Acrylamide-free
Certifications & Compliance: United States Pharmacopeia (USP), European Pharmacopeia (Ph. Eur.), Japan Pharmacopeia (JP), ISO 9001, FDA IID, EXCiPACT, Kosher, Chinese Pharmacopeia (ChP), Halal, GMP
Synonyms: Manitol, Cordycepic Acid, D-(-)-Mannitol, Manicol, 1,2,3,4,5,6-Hexanehexol
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TypeDocument Name
Safety Data Sheet
PEARLITOL® 100 SD Mannitol - Pharma Safety Data Sheet (REC - EN)
PEARLITOL® 100 SD Mannitol - Pharma Safety Data Sheet (REC - EN)
Safety Data Sheet
Technical Data Sheet
PEARLITOL® 100 SD Technical Data Sheet
PEARLITOL® 100 SD Technical Data Sheet
Technical Data Sheet
Safety Data Sheet
PEARLITOL® 100 SD Mannitol - Pharma Safety Data Sheet (US - EN)
PEARLITOL® 100 SD Mannitol - Pharma Safety Data Sheet (US - EN)
Safety Data Sheet
Safety Data Sheet
PEARLITOL® 100 SD Mannitol - Pharma Safety Data Sheet (REC - ES)
PEARLITOL® 100 SD Mannitol - Pharma Safety Data Sheet (REC - ES)
Safety Data Sheet
Safety Data Sheet
PEARLITOL® 100 SD Mannitol - Pharma Safety Data Sheet (REC - PT)
PEARLITOL® 100 SD Mannitol - Pharma Safety Data Sheet (REC - PT)
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® 100 SD Mannitol - Pharma Features & Benefits

Applications & Uses

Properties

Physical Form
Appearance
White or almost white crystals or 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. 35%Laser
Particle Size Part (min. 150 micron Beckman)max. 35%Laser
Particle Size Part (min. 30 micron Sympatec)max. 70%Laser
Particle Size Part (min. 75 micron Beckman)max. 70%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

Technical Details & Test Data

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Packaging & Availability

Packaging Information
  • ROQ Product Code: 450310
  • Article (SKU) Code: 450310105
  • Package Size & Type: 20 kg lined cardboard box

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® 100 SD Mannitol - Pharma
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