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

Identification & Functionality

Chemical Family

Modifed Starches

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

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,

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

	Value	Units	Test Method / Conditions
Critical Micelle Concentration	53	g/l	-
De Value	approx. 3	-	-
Hydrogen Peroxide	max. 20	ppm	USP
pH Value (Solution)	3.0 - 9.0	-	USP
Water Content (LOD)	max. 15	%	-

Physico-Chemical Properties

	Value	Units	Test Method / Conditions
Loss on Drying	max. 15	%	USP
Sulfur Dioxide Content	max. 50	ppm	USP
Sulphated Ash Content	max. 1.5	%	USP

Microbiological Values

	Value	Units	Test Method / Conditions
Total Count	max. 1000	per gram	USP
Total Yeasts and Moulds Count	max. 100	per gram	USP

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

Conformity

Current pharmacopeia pregelatinised modified starch U.S.P. / N.F.

Technical Details & Test Data

Morphology

Water Sorption Isotherm at 20°C

Glass Transition Temperature vs. Water Content

Surface Tension in Water

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Packaging & Availability

Packaging Information

• ROQ Product Code: 656222
• Article (SKU) Code: 656222105N
• Package Size & Type: 20 kg PE lined pinch bottom paper 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.