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CLEARGUM® CO 03 Pregelatinized Octenyl Succinate Starch, Low Viscosity - Pharma

CLEARGUM® CO 03 is a pregelatinized, low-viscosity octenyl succinate starch that can be used as an emulsifier and solubilizer in pharmaceutical and nutraceutical formulations including encapsulation of vitamins or APIs. and as a binder in wet granulation. Benefits BSE-free Halal and Kosher certified Melamine-free Non-GMO Non-hazardous TSE-free Vegan Features Food modified starch (E1450) Free of off-odors Low viscosity Tasteless

Brand: CLEARGUM (4 products)

Chemical Name: Octenyl Succinate Starch

Dosage Form: Granules, Pellets, Powder & Powder Blends, Sachets, Stick, Suspension, Syrups

Labeling Claims: BSE-free, Halal, Kosher, Melamine-free, Non-GMO, Non-Hazardous, TSE-free, Vegan

Certifications & Compliance: EXCiPACT, FDA Compliant, GMP, Halal, ISO 50001, ISO 9001, Kosher, National Formulary (NF), United States Pharmacopeia (USP)

Manufacturing Technology: Encapsulation, Wet Granulation

Technical Data SheetSafety Data Sheet

Enhanced TDS

Knowde-enriched technical product data sheet

Identification & Functionality

Chemical Family
Modifed Starches
Chemical Name
Octenyl Succinate Starch
Pharma & Nutraceuticals Functions
Binder,
Emulsifier,
Solubilizer
CAS No.
52906-93-1
Technologies
Pharmaceuticals & Nutraceuticals
Product Families
Pharmaceuticals & Nutraceuticals — Excipients
Binders & Disintegrants,
Emulsifiers & Stabilizers,
Solvents & Solubilizers
Molecular Weight

Roquette CLEARGUM CO 03 Pregelatinized Octenyl Succinate Starch, Low Viscosity - Pharma Molecular Weight

Features & Benefits

Benefit Claims
Emulsifying,
Free Of Off-Odors,
Low Viscosity,
Solubilizing,
Tasteless
Labeling Claims
BSE-free,
Halal,
Kosher,
Melamine-free,
Non-GMO,
Non-Hazardous,
TSE-free,
Vegan

Applications & Uses

Markets
Food & Nutrition,
Healthcare & Pharma
Applications
Healthcare & Pharma — Drug Delivery & Care Solutions
Oral
Food & Nutrition — Nutrition & Well Being
Nutraceuticals & Supplements
Dosage Form
Granules,
Pellets,
Powder & Powder Blends,
Sachets,
Stick,
Suspension,
Syrups
Manufacturing Technology
Encapsulation,
Wet Granulation
Application
CLEARGUM® CO 03 is a pregelatinized low viscosity octenyl succinate starch used in pharmaceutical and nutraceutical formulations offering emulsifying and solubilizing properties (encapsulation of vitamins or API). It is also used as a binder in wet granulation. CLEARGUM® CO 03 is a food modified starch (E1450). It has a Dextrose Equivalent (DE) value of about 3.

Properties

Physical Form
Powder,
Solid
Odor
Odorless
Taste
Tasteless
Soluble in
Cold water
Insoluble in
Organic solvents
Typical Properties
ValueUnitsTest Method / Conditions
Critical Micelle Concentration53g/l-
De Valueapprox. 3--
Hydrogen Peroxidemax. 20ppmUSP
pH Value (Solution)3.0 - 9.0-USP
Water Content (LOD)max. 15%-
Physico-Chemical Properties
ValueUnitsTest Method / Conditions
Loss on Dryingmax. 15%USP
Sulfur Dioxide Contentmax. 50ppmUSP
Sulphated Ash Contentmax. 1.5%USP
Microbiological Values
ValueUnitsTest Method / Conditions
Total Countmax. 1000per gramUSP
Total Yeasts and Moulds Countmax. 100per gramUSP

Regulatory & Compliance

Certifications & Compliance
EXCiPACT,
FDA Compliant,
GMP,
Halal,
ISO 50001,
ISO 9001,
Kosher,
National Formulary (NF),
United States Pharmacopeia (USP)
Chemical Inventories
AICS (Australia),
DSL (Canada),
EINECS (EU),
ENCS (Japan),
IECSC (China),
ISHL (Japan),
KECI (Korea),
NZIoC (New Zealand),
PICCS (Phillipines),
TCSI (Taiwan),
TSCA (USA)
Grade
Pharma Grade
Quality Standards
ICH Q7
Conformity
Current pharmacopeia pregelatinised modified starch U.S.P. / N.F.

Technical Details & Test Data

Morphology

Roquette CLEARGUM CO 03 Pregelatinized Octenyl Succinate Starch, Low Viscosity - Pharma Morphology

Water Sorption Isotherm at 20°C

Roquette CLEARGUM CO 03 Pregelatinized Octenyl Succinate Starch, Low Viscosity - Pharma Water Sorption Isotherm at 20°C

Glass Transition Temperature vs. Water Content

Roquette CLEARGUM CO 03 Pregelatinized Octenyl Succinate Starch, Low Viscosity - Pharma Glass Transition Temperature vs. Water Content

Surface Tension in Water

Roquette CLEARGUM CO 03 Pregelatinized Octenyl Succinate Starch, Low Viscosity - Pharma Surface Tension in Water

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Packaging & Availability

Packaging Information
  • Article (SKU) Code: 5100001513
  • Package Size & Type: 20 KG BAG

Storage & Handling

Storage & Shelf Life
  • Shelf life manufacturing date + 5 years.
  • Store at room temperature, in a dry place, and in its unopened original packing.
  • Minimum durability date of the packaged product manufacturing date + 24 months.