POLYOX™ WSR - N10 NF Grade

1 of 31 products in this brand
POLYOX™ WSR - N10 NF Grade is an off-white powder with water-soluble properties. It's used as a binder and thickener in cleaning products and pharmaceuticals. Its applications include gels, osmotic pump tablets, and regular tablets, and it's manufactured using direct compression technology. Additionally, it serves as a controlled release agent.

Chemical Name: Polyethylene Oxide, Pyrogenic Silica

CAS Number: 25322-68-3

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

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 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), 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

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Identification & Functionality

Chemical Family
Ethylene Oxide Copolymers,
Polyethers
Chemical Name
Polyethylene Oxide,
Pyrogenic Silica
Country of Origin
United States of America (USA)
Ingredient Origin
Non-Animal Origin,
Plant Origin,
Synthetic
Pharma & Nutraceuticals Functions
Binder,
Controlled Release Agent
Plastics & Elastomers Functions
Binder,
Film Former,
Flocculant,
Lubricant (Internal)
Technologies
Pharmaceuticals & Nutraceuticals
Product Families
Pharmaceuticals & Nutraceuticals — Excipients
Binders & Disintegrants,
Modified & Controlled Release

Features & Benefits

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 Tested on Animals,
Oxidatively Degradable,
Plant-Based,
Residual Solvent -Free,
TSE-free,
Vegan,
Vegetarian,
Zinc-free
Materials Features
Crosslinkable,
Drag Reduction,
Excellent Thermoplasticity,
Good Thickening Properties,
Good Wet Adhesion Strength,
High Binding Power,
Low Moisture Absorption,
Low Toxicity,
Non-Ionic,
Viscoelastic,
Water Soluble

Applications & Uses

Markets
Healthcare & Pharma
Applications
Healthcare & Pharma — Drug Delivery & Care Solutions
Oral,
Topical
Segments
Pharmaceutical
Applications
Pharmaceutical — Controlled release
Pharmaceutical — Immediate 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
ValueUnitsTest Method / Conditions
Silicon Dioxide Conent*0.8 - 3.0%PSM 101992
Butylated Hydroxytoluene Content*50 - 250mg/KgPSM 102192
Free Ethylene Oxide*0 - 10mg/KgPSM 102104
Specifications
ValueUnitsTest 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)*30 - 50mPa.sPSM 101936
Heavy Metals
ValueUnitsTest Method / Conditions
Alkaline Earth Metals (as Calcium Oxide)*0.0 - 1.0%PSM 102225
Heavy Metals*0.001wt%-
Screen Test
ValueUnitsTest 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),
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