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PEARLITOL® Biopharma-Mannitol

PEARLITOL® Biopharma-Mannitol is a high-purity stabilizer, specifically D-mannitol. It is widely used in pharmaceutical and nutraceutical applications, including injectables and functional ingredients. The product is water-soluble and available in crystal and powder forms. With low endotoxin levels, PEARLITOL® Biopharma-Mannitol serves as an excipient, emulsifier, and stabilizer in food and pharmaceutical formulations.

Brand: PEARLITOL (10 products)

Chemical Name: D-mannitol

CAS Number: 69-65-8

Labeling Claims: High Purity, Not Listed In California Proposition 65

Certifications & Compliance: Chinese Pharmacopeia (ChP), European Pharmacopeia (Ph. Eur.), Japan Pharmacopeia (JP), National Formulary (NF), United States Pharmacopeia (USP)

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

Technical Data Sheet Safety Data Sheet

Enhanced TDS

Knowde-enriched technical product data sheet

Identification & Functionality

Chemical Family: Alcohols
Chemical Name: D-mannitol
Pharma & Nutraceuticals Functions: Stabilizer
Technologies: Food Ingredients,
Pharmaceuticals & Nutraceuticals
Product Families: Pharmaceuticals & Nutraceuticals — Excipients
Emulsifiers & Stabilizers
Pharmaceuticals & Nutraceuticals — Nutraceuticals & Supplements
Supplements & Functional Ingredients
Food Ingredients — Nutrition & Fortification
Functional Ingredients

Features & Benefits

Benefit Claims (Health): Low Endotoxin
Labeling Claims: High Purity,
Not Listed In California Proposition 65

Applications & Uses

Dosage Form: Injectables
Application Information: PEARLITOL® Biopharma-Mannitol low endotoxin mannitol provides protein stabilization in biopharmaceutical downstream applications.

Properties

Physical Form

Soluble In

Appearance

White or almost white crystalline powder

Soluble in

Water

Insoluble in

Ethanol

Physico-Chemical Properties


	Value	Units	Test Method / Conditions
Loss on Drying	max. 0.5	%w/w	EP, USP-NF, JP
Reducing Sugars (as is)	max. 0.10	%w/w	EP, USP-NF, JP
Mannitol (on dissolved solution)	97.0 - 102.0	%w/w	EP, USP-NF, JP
Impurity A (D-Sorbitol)	max. 2.0	%w/w	EP, USP-NF, JP
Sum of Impurities B+C (Maltitol + Isomalt)	max. 2.0	%w/w	EP, USP-NF, JP
Unspecified Impurities	max. 0.10	%w/w	EP, USP-NF, JP
Total Impurities	max. 2.0	%w/w	EP, USP-NF, JP
Conductivity	max. 20	μS/cm	EP, USP-NF, JP
Nickel Content	max. 1	mg/kg	USP-NF, JP
Heavy Metals	max. 5	mg/kg	JP
Melting Point	165 - 170	°C	EP, USP-NF, JP
Solubility	96	%	-
Average Molecular Weight	182.2	g/mol	-
Glass Transition Temperature (of the cryo-concentrated phase Tg)	-29.3	°C	-
Melting temperature	165 - 170	°C	-

Microbiological Values


	Value	Units	Test Method / Conditions
Total Aerobic Microbial Count	max. 100	/g	EP, USP-NF
Total Yeasts and Moulds Count	max. 100	/g	EP, USP-NF
Escherichia Coli	Not detected	/g	EP, USP-NF
Salmonella	Not detected	/10g	EP
Pseudomonas aeruginosa	Not detected	/g	-
Bacterial Endotoxins	max. 1	eu/g	-

Regulatory & Compliance

Packaging & Availability

Packaging Information: This product is available as 12 kg Polyethylene drum + polyethylene bag

Storage & Handling

Storage Information: Storage Conditions for Pack Material : We recommend to preserve the product in its unopened original packaging, preferably protected from wide variations in temperature and humidity. Upon opening, use the product as quickly as possible to prevent moisture regain

Expiry date of the packed product : Manufacturing date + 5 years, in its unopened packaging.