POLYOX™ WSR N 80NF TG LEO

1 of 31 products in this brand

POLYOX™ WSR N 80NF TG LEO, in an off-white powder form, serves as a binder and thickener in cleaning and pharmaceutical formulations. Its water solubility makes it suitable for various applications, while its direct compression manufacturing technology ensures efficient production processes. Additionally, it functions as a controlled release agent, adding value to pharmaceutical formulations.

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 Listed In California Proposition 65, 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), Clean Water Act (CWA) Certified, 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

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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,
Lubricant,
Thickener,
Viscosity Modifier
Technologies: Pharmaceuticals & Nutraceuticals
Product Families: Pharmaceuticals & Nutraceuticals — Excipients
Base Fluids, Glidants & Lubricants,
Binders & Disintegrants,
Formulation & Processing Aids,
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 Listed In California Proposition 65,
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

Appearance

Pass

Physical Properties


	Value	Units	Test Method / Conditions
pH (at 5% aqueous solution)*	8.0 - 10.0	-	PSM 102175

Composition


	Value	Units	Test Method / Conditions
Silicon Dioxide Conent*	0.8 - 3.0	%	PSM 101992
Butylated Hydroxytoluene Content*	50 - 150	mg/Kg	PSM 102192
Free Ethylene Oxide*	0 - 1	mg/Kg	PSM 102104

Specifications


	Value	Units	Test Method / Conditions
Identification (A,B)*	Pass	-	Current USP/EP/JP
Organic Volatile Impurities*	Pass	-	Current USP Organic Volatile Impurities
Loss on Drying (at 105°C, 45 min)*	0.0 - 1.0	%	PSM 102188
Residue on Ignition*	0.0 - 2.0	%	Current NF
Viscosity (at 25 °C, Brookfield. at 5%, Brookfield RVF, Spindle 1, Speed 50 RPM)*	70 - 90	mPa.s	PSM 101936

Heavy Metals


	Value	Units	Test Method / Conditions
Alkaline Earth Metals (Calcium Hydroxide)*	0.0 - 1.0	%	PSM 102225

Screen Test


	Value	Units	Test Method / Conditions
Screen (< 74 micron, through 200 mesh)*	0 - 40	%	PSM 102261
Screen (< 149 micron, through 100 mesh)*	40 - 70	%	PSM 102261
Screen (< 840 micron, through 20 mesh)*	96 - 100	%	PSM 102261
Screen (< 2000 micron, through 10 mesh)*	min. 100	%	PSM 102261

Note

*NF and Ph. Eur. ID tests; “A” and “B” on a quarterly basis. ID tests “C” (NF and Ph. Eur.) and “D” (Ph.Eur.) will be completed by exception only.