PEARLITOL® 160 C - Mannitol

PEARLITOL® 160 C - Mannitol is a versatile excipient for nutraceutical and pharmaceutical oral dosage applications.  Suitable for use in capsules, granules, orally disintegrating tablets (ODTs), powders, and tablets, PEARLITOL® 160 C supports direct compression manufacturing. It boasts high physical and chemical stability, and it is non-hygroscopic, ensuring long-lasting quality. Ideal for healthcare and pharma , this excipient enhances drug delivery and care solutions with its excellent performance and stability.

Brand: PEARLITOL (10 products)

Chemical Name: D-mannitol

Functions: Binder, Filler, Sweetener

CAS Number: 69-65-8

Dosage Form: Capsules, Granules, Orally Disintegrating Tablets (ODTs), Powder & Powder Blends, Tablets

Labeling Claims: Non-Cariogenic, Sugar-free

Synonyms: 1,2,3,4,5,6-Hexanehexol, Cordycepic Acid, D-(-)-Mannitol, Manicol, Manitol

Technical Data SheetSafety Data Sheet

Enhanced TDS

Knowde-enriched technical product data sheet

Identification & Functionality

Features & Benefits

Applications & Uses

Properties

Physical Form
Soluble In
Appearance
White or almost white crystalline powder
Taste
Pleasant taste slight sweetness and cooling effect
Odor
Odorless
Soluble in
Water
Insoluble in
Ethanol
Typical Properties
ValueUnitsTest Method / Conditions
Molecular Weight182.2g/mol
D-Mannitol97.0 - 102.0%EP / USP / JP
Water Content (LOD)max. 0.5%
Conductivitymax. 20microS/cm-
Melting Point165 - 170°CEP / USP / JP
Reducing Sugarsmax. 1%EP / USP / JP
Impurity A : D-Sorbitolmax. 2%EP / USP / JP
Melting Temperature169°C
Sum of Impurities B and Cmax. 2%EP / USP / JP
Unspecified Impuritiesmax. 1%EP / USP / JP
Average Mean Particle Diameter160µm
Total Impuritiesmax. 2%EP / USP / JP
Heavy Metalsmax. 5mg/kgJP
Nickel1.0mg/kgUSP / JP
Loss on Dryingmax. 0.5mg/kgEP / USP / JP
Microbiological Values
ValueUnitsTest Method / Conditions
Total Aerobic Microbial Countmax. 1000CFU/gEP / USP
Total Yeasts and Molds Countmax. 100CFU/gEP / USP
Escherichia ColiNot detected in 1g-EP / USP
SalmonellaNot detected in 10g-EP
Particle Size Distribution
ValueUnitsTest Method / Conditions
Particle Size (min. 500 Microns)max. 10%-
Particle Size (min. 315 Microns)max. 25%-
Particle Size (min. 40 Microns)max. 60%-
Powder Characteristics
ValueUnitsTest Method / Conditions
Bulk Density0.64g/cm³
Tapped Density0.69g/cm³
True Density1.514g/cm³
Specific Surface Area0.25m²/g
Solubility Data
ValueUnitsTest Method / Conditions
Soluble in Water (at 25°C)216mg/ml

Regulatory & Compliance

Technical Details & Test Data

Morphology

Water Sorption Isotherm (at 20°C)

Packaging & Availability

Packaging Information
  • Article (SKU) Code: 5100001089
  • Package Size & Type: 50 KG POWDER DRUM

Storage & Handling

Shelf Life
3 years
Storage Condition
  • 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.