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PEARLITOL® 50 C Mannitol - Pharma

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Chemical Name: Mannitol
Function: Filler, Binder, Sweetener
CAS Number: 87-78-5
Dosage Form: Orally Disintegrating Tablets (ODTs), Powder & Powder Blends, Tablets, Granules, Capsules
Labeling Claims: Sugar-free, Halal, Kosher, Melamine-free, Non-Carcinogenic, Vegan, Acrylamide-free
Synonyms: Manitol, Cordycepic Acid, Manicol, 1,2,3,4,5,6-Hexanehexol
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Samantha LeTechnical Expert at RoquettePlease reach out to me with any questions, I am happy to assist you in finding the right product or learning more about our storefront.
Please reach out to me with any questions, I am happy to assist you in finding the right product or learning more about our storefront.

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Identification & Functionality

PEARLITOL® 50 C 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. 100 micron)max. 25%Laser
Particle Size Part (min. 20 micron)max. 55%Laser
Particle Size Part (min. 250 micron)max. 5%Laser
Reducing Sugarsmax. 0.1%EP / USP / JP
Microbiological Values
ValueUnitsTest Method / Conditions
Escherichia coli (Monitoring plan)Not Detectedper gramEP / USP
SalmonellaNot Detectedper 10gEP
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: 22.68 kg lined fiber drum

Storage & Handling

Shelf Life
3 Years
PEARLITOL® 50 C Mannitol - Pharma
Roquette