POLYOX™ WSR Coagulant LEO NF Grade

1 of 31 products in this brand

POLYOX™ WSR Coagulant LEO NF Grade is an off-white to white powder that is water soluble. It is used in dosage forms such as abuse deterrent tablets, capsules, and gels, providing essential properties for these pharmaceutical applications.

Chemical Name: Polyethylene Oxide

CAS Number: 25322-68-3

Dosage Form: Abuse Deterrent Tablets & Capsules, Gels, Osmotic Pump Tablet, Tablets

Labeling Claims: Allergen-free, Chlorine-free, Diethylene Glycol-free, Ethylene Glycol-free, Halal, Heavy Metal-free, Kosher, Naturally Derived, Nitrosamines-free, No Added Formaldehyde, Not Tested on Animals, Plant-Based, Residual Solvent -Free, Vegan, Vegetarian

Certifications & Compliance: Belgian Law And Codex Alimentarius Standards, British Pharmacopeia (BP), CFDA Compliant (China), Chinese Pharmacopeia (ChP), EXCiPACT, European Pharmacopeia (Ph. Eur.), GMP, Halal, ICH Q3C, ICH Q3D, Japan DMF, Japan Pharmacopeia (JP), Kosher, National Formulary (NF), US DMF, United States Pharmacopeia (USP)

Manufacturing Technology: Direct Compression

Technical Data Sheet Safety Data Sheet

TypeDocument Name

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Enhanced TDS

Identification & Functionality

Chemical Family: Ethylene Oxide Copolymers,
Polyethers
Chemical Name: Polyethylene Oxide
Ingredient Origin: Plant Origin
Pharma & Nutraceuticals Functions: Binder,
Controlled Release Agent
Technologies: Pharmaceuticals & Nutraceuticals
Product Families: Pharmaceuticals & Nutraceuticals — Excipients
Binders & Disintegrants,
Modified & Controlled Release

Features & Benefits

Labeling Claims: Allergen-free,
Chlorine-free,
Diethylene Glycol-free,
Ethylene Glycol-free,
Halal,
Heavy Metal-free,
Kosher,
Naturally Derived,
Nitrosamines-free,
No Added Formaldehyde,
Not Tested on Animals,
Plant-Based,
Residual Solvent -Free,
Vegan,
Vegetarian

Applications & Uses

Markets: Healthcare & Pharma
Applications: Healthcare & Pharma — Drug Delivery & Care Solutions
Oral,
Topical
Segments: Pharmaceutical
Applications: Pharmaceutical — Controlled release
Dosage Form: Abuse Deterrent Tablets & Capsules,
Gels,
Osmotic Pump Tablet,
Tablets
Manufacturing Technology: Direct Compression

Properties

Physical Form

Soluble In

Physical Properties


	Value	Units	Test Method / Conditions
pH (at 1% aqueous solution)	8.0 - 10.0	-	PSM 102175

Typical Properties


	Value	Units	Test Method / Conditions
Identification (A,B)*	Pass	-	Current USP/EP/JP
Loss on Drying	0.0 - 1.0	%	PSM 102188
Residue on Ignition	0.0 - 2.0	%	Current NF
Viscosity (at 1% aqueous solution, Brookfield)	6,400 - 7,500	mPa.s	PSM 101962
Alkaline Earth Metals	0.0 - 1.0	%	PSM 102225

Composition


	Value	Units	Test Method / Conditions
Silicon Dioxide Conent	0.8 - 3.0	%	PSM 101992
Butylated Hydroxytoluene Content	100 - 1,000	mg/Kg	PSM 102192
Free Ethylene Oxide	0 - 1	mg/Kg	PSM 102104

Heavy Metals


	Value	Units	Test Method / Conditions
Heavy Metals	max. 10	ppm	-

Screen Test


	Value	Units	Test Method / Conditions
Screen (<74 micron, through 200 mesh)*	0 - 40	%	PSM 102261
Screen (<149 micron, through 100 mesh)	35 - 75	%	PSM 102261
Screen (<840 micron, through 20 mesh)	96 - 100	%	PSM 102261
Screen (<2000 micron, through 10 mesh)	min. 100	%	PSM 102261

Note

Alkaline earth metals as CaO.
Volatiles - 45 min at 105°C.
Residue on ignition = non-silicon dioxide.
Viscosity - Brookfield RVF, spindle 2, speed 2 rpm, 25°C.
*[AB]
PHS - All section names come under PHS

Regulatory & Compliance

Certifications & Compliance: Belgian Law And Codex Alimentarius Standards,
British Pharmacopeia (BP),
CFDA Compliant (China),
Chinese Pharmacopeia (ChP),
EXCiPACT,
European Pharmacopeia (Ph. Eur.),
GMP,
Halal,
ICH Q3C,
ICH Q3D,
Japan DMF,
Japan Pharmacopeia (JP),
Kosher,
National Formulary (NF),
US DMF,
United States Pharmacopeia (USP)
Chemical Inventories: KECI (Korea)
Quality Standards: GMP