POLYOX™ WSR - N750 NF Grade

1 of 31 products in this brand

POLYOX™ WSR - N750 NF Grade is available in various dosage forms including gels, osmotic pump tablets, and traditional tablets. Utilizing direct compression manufacturing technology, it serves applications in both oral and topical drug delivery within the healthcare and pharmaceutical markets. With its properties as a binder and thickener, this white, water-soluble powder aids in formulation processes.

Chemical Name: Polyethylene Oxide

CAS Number: 25322-68-3

Functions: Binder, Controlled Release Agent, Film Former, Flocculant, Lubricant, Lubricant (Internal), Thickener, Viscosity Modifier

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

Labeling Claims: Allergen-free, Animal Products-free, BSE-free, Chlorine-free, Dairy-free, Diethylene Glycol-free, Doping Substances-free, Ethylene Glycol-free, Halal, Heavy Metal-free, Kosher, Naturally Derived, Nitrosamines-free, No Added Formaldehyde, Non-GMO, Not Listed In California Proposition 65, Not Tested on Animals, Oxidatively Degradable, Plant-Based, Residual Solvent -Free, TSE-free, Vegan, Vegetarian, Zinc-free

Certifications & Compliance: Belgian Law And Codex Alimentarius Standards, British Pharmacopeia (BP), CFDA Compliant (China), Chinese Pharmacopeia (ChP), Clean Water Act (CWA) Certified, Directive 1333/2008/EC, Directive 2001/83/EC, Directive 2002/95/EC, Directive 2011/65/EU (RoHS 2), Directive 2023/2055/EU, EC No. 1935/2004, EC No. 2023/2006, EC No.1907/2006, EU Cosmetic Regulation 1223/2009 Compliant, EU Directive 2002/72/EC, EU Packaging Directive (94/62/EC), EXCiPACT, European Pharmacopeia (Ph. Eur.), FFDCA, GMP, Generally Recognized As Safe (GRAS), Halal, ICH Q3C, ICH Q3D, ISO 9001, Japan DMF, Japan Pharmacopeia (JP), Kosher, National Formulary (NF), Regulation (EC) No. 338/97, Regulation (EU) No. 10/2011 (PIM), Regulation (EU) No. 1829/2003, Regulation (EU) No. 1830/2003, Regulation (EU) No. 1935/2004, US DMF, United States Pharmacopeia (USP)

Manufacturing Technology: Direct Compression

Technical Data Sheet Safety Data Sheet Brochure

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Identification & Functionality

Chemical Family: Ethylene Oxide Copolymers,
Polyethers
Chemical Name: Polyethylene Oxide
Country of Origin: United States of America (USA)
Ingredient Origin: Plant Origin
Pharma & Nutraceuticals Functions: Binder,
Controlled Release Agent,
Lubricant,
Thickener,
Viscosity Modifier
Plastics & Elastomers Functions: Binder,
Film Former,
Flocculant,
Lubricant (Internal)
Technologies: Pharmaceuticals & Nutraceuticals
Product Families: Pharmaceuticals & Nutraceuticals — Excipients
Base Fluids, Glidants & Lubricants,
Binders & Disintegrants,
Formulation & Processing Aids,
Modified & Controlled Release

Applications & Uses

Markets: Healthcare & Pharma
Applications: Healthcare & Pharma — Drug Delivery & Care Solutions
Oral,
Topical
Segments: Pharmaceutical
Applications: Pharmaceutical — Controlled release
Compatible Polymers & Resins: Cellulose & Cellulosics,
Ethylene Vinyl Acetate (EVA),
Polycaprolactone (PCL),
Polyethylenes (PE),
Polystyrenes (PS),
Polyurethanes (PU),
Polyvinyl Acetate (PVA),
Polyvinyl Alcohol (PVOH)
Dosage Form: Abuse Deterrent Tablets & Capsules,
Gels,
Osmotic Pump Tablet,
Tablets
Manufacturing Technology: Direct Compression
Plastics & Elastomers Processing Methods: Blow Molding,
Casting,
Compression Molding,
Injection Molding,
Single Screw Extrusion

Properties

Physical Form

Powder

Soluble In

Propylene Glycol Soluble,

Water Soluble

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 - 10	mg/Kg	PSM 102104

Specifications


	Value	Units	Test Method / Conditions
pH (at 1% aqueous solution)*	8.0 - 10.0	-	PSM 102175
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 25 °C, Brookfield, 1%, Brookfield RVF, Spindle 2, Speed 2 RPM)*	600 - 1,200	mPa.s	PSM 101936

Heavy Metals


	Value	Units	Test Method / Conditions
Alkaline Earth Metals (as Calcium Oxide)*	0.0 - 1.0	%	PSM 102225
Heavy Metals*	0.001	wt%	-

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

*PHS - All section names come under PHS
[AB] = Audit Basis

Regulatory & Compliance

Certifications & Compliance: Belgian Law And Codex Alimentarius Standards,
British Pharmacopeia (BP),
CFDA Compliant (China),
Chinese Pharmacopeia (ChP),
Clean Water Act (CWA) Certified,
Directive 1333/2008/EC,
Directive 2001/83/EC,
Directive 2002/95/EC,
Directive 2011/65/EU (RoHS 2),
Directive 2023/2055/EU,
EC No. 1935/2004,
EC No. 2023/2006,
EC No.1907/2006,
EU Cosmetic Regulation 1223/2009 Compliant,
EU Directive 2002/72/EC,
EU Packaging Directive (94/62/EC),
EXCiPACT,
European Pharmacopeia (Ph. Eur.),
FFDCA,
GMP,
Generally Recognized As Safe (GRAS),
Halal,
ICH Q3C,
ICH Q3D,
ISO 9001,
Japan DMF,
Japan Pharmacopeia (JP),
Kosher,
National Formulary (NF),
Regulation (EC) No. 338/97,
Regulation (EU) No. 10/2011 (PIM),
Regulation (EU) No. 1829/2003,
Regulation (EU) No. 1830/2003,
Regulation (EU) No. 1935/2004,
US DMF,
United States Pharmacopeia (USP)
Chemical Inventories: AICS (Australia),
DSL (Canada),
EINECS (EU),
ELINCS (EU),
ENCS (Japan),
IECSC (China),
ISHL (Japan),
KECI (Korea),
NDSL (Canada),
NZIoC (New Zealand),
PICCS (Phillipines),
TSCA (USA)
Quality Standards: GMP

Packaging & Availability

Packaging Type: Boxes,
Drums