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POLYSORB® 85/70/00

POLYSORB® 85/70/00 Partially dehydrated sorbitol liquid is a plasticizer in soft capsules and orally dissolving films. It can be used in pharmaceutical dosage forms.POLYSORB® 85/70/00 is an aqueous solution of D-sorbitol and 1.4- sorbitans that has been developed by Roquette as a plasticizer for soft gelatine capsule applications. The advantage of this product in soft gels relates to its remarkable compatibility with gelatin that ensures no migration over time thereby preventing any defects like graining when crystallizing plasticizers are used or leaching phenomena either into the filler media or at the surface of the soft gel.

Brand: POLYSORB (3 products)

Ingredient Name: Sorbitol

Chemical Name: D-Glucitol

CAS Number: 50-70-4

Dosage Form: Capsules, Orally Disintegrating Films (ODFs), Orally Disintegrating Tablets (ODTs), Soft Gels

Synonyms: D-Sorbitol, D-Sorbol, Diakarmon, G-ol, Glc-ol, Glucarine, Karion, Multitol, Sionit, Sionite, Sorbilande

Technical Data SheetSafety Data Sheet

Enhanced TDS

Knowde-enriched technical product data sheet

Identification & Functionality

Chemical Name
D-Glucitol
Ingredient Name
Sorbitol
Food Ingredients Functions
Nutritive Sweetener
Pharma & Nutraceuticals Functions
Plasticizer
Technologies
Food Ingredients,
Pharmaceuticals & Nutraceuticals
Product Families
Pharmaceuticals & Nutraceuticals — Excipients
Formulation & Processing Aids
Food Ingredients — Functional Additives
Processing Aids
Food Ingredients — Taste & Flavor
Sweeteners & Syrups
Chemical Structure

Features & Benefits

Food Ingredients Features
Anti-Crystallization,
Improved Stability,
Odorless

Applications & Uses

Markets
Healthcare & Pharma
Applications
Healthcare & Pharma — Drug Delivery & Care Solutions
Oral
Dosage Form
Capsules,
Orally Disintegrating Films (ODFs),
Orally Disintegrating Tablets (ODTs),
Soft Gels
Product Applications
  • POLYSORB® 85/70/00 partially dehydrated sorbitol liquid is a plasticizer for soft gelatin capsules and orally dissolving films.
  • It's remarkable compatibility with gelatin ensures no migration over time, thereby preventing any defects like graining when crystallizing plasticizers are used or leaching phenomena either into the filler media or at the surface of the soft gel.
  • POLYSORB® 85/70/00 can be used in pharmaceutical dosage forms.

Properties

Physical Form
Liquid
Appearance
Clear to colorless syrupy liquid, Clear. colorless syrupy liquid
Taste
Sweet
Odor
Sweet
Miscible In
Water
Insoluble in
Vegetable oils, Mineral oils
Typical Properties
ValueUnitsTest Method / Conditions
Average Molecular Weight (D-Sorbitol)182.2g/mol
Average Molecular Weight (1,4-Sorbitan)164.2 g/mol
Water Content (Loss on Drying)max. 32%
Physico-Chemical Properties
ValueUnitsTest Method / Conditions
Dry Substance83 - 85%(w/w)-
Reducing Sugarsmax. 0.5%(w/w)(on D.S.)
pH (at 14 %(w/w))5 - 7--
Sulfated Ashmax. 0.2%(w/w)-
Nickelmax. 1mg/kg-
Composition
ValueUnitsTest Method / Conditions
D-Sorbitol Content (on D.S)35 - 45%
1,4-Sorbitan Content (on D.S)24 - 28%

Regulatory & Compliance

Certifications & Compliance
European Pharmacopeia (Ph. Eur.),
ISO 9001,
National Formulary (NF),
United States Pharmacopeia (USP)
Chemical Inventories
EINECS (EU),
IECSC (China),
KECI (Korea),
NCI (Vietnam),
NZIoC (New Zealand),
Russian Federation Unified List of Chemicals,
TCSI (Taiwan),
TECI (Thailand),
TSCA (USA)
Quality Standards
ICH Q7

Packaging & Availability

Packaging Information
  • Article (SKU) Code: 5100002430
  • Package Size & Type: 275 KG LIQUID DRUM

Storage & Handling

Shelf Life
24 months
Storage Condition

We recommend to preserve the product in its unopened original packaging, preferably
Protected from wide variations in temperature and humidity. The product durability may vary according to packaging type and manufacturing plant.