POLYOX™ WSR - N12K FP NF Grade

1 of 31 products in this brand
POLYOX™ WSR - N12K FP NF Grade composed of ethylene oxide copolymers and polyethylene oxide, serves diverse functions in pharmaceutical formulations. It finds application in abuse-deterrent tablets and capsules, gels, osmotic pump tablets, and regular tablets. This versatile ingredient acts as a binder, thickener, and controlled release agent, ensuring optimal performance. Available in powder form, it demonstrates water solubility, facilitating easy integration into formulations for enhanced effectiveness.

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, Fungicide-free, Gluten-free, Halal, Herbicide-free, Kosher, Nitrosamines-free, Non-GMO, Not Listed In California Proposition 65, Not Tested on Animals, Oxidatively Degradable, Pesticide-free, Residual Solvent -Free, TSE-free, Vegan, Vegetarian, Zinc-free

Certifications & Compliance: Belgian Law And Codex Alimentarius Standards, British Pharmacopeia (BP), 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.), FDA Compliant, FFDCA, GMP, Generally Recognized As Safe (GRAS), ICH Q3C, ISO 9001, Japan Pharmacopeia (JP), 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, United States Pharmacopeia (USP)

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Enhanced TDS

Identification & Functionality

Features & Benefits

Applications & Uses

Properties

Physical Form
Soluble In
Physical Properties
ValueUnitsTest Method / Conditions
pH (at 2%, aqueous solution)8.0 - 10.0-PSM 102175
Typical Properties
ValueUnitsTest Method / Conditions
Identification (A,B)*Pass-Current Usp/Ep/Jp
Loss on Drying0.0 - 1.0%PSM 102188
Residue on Ignition0.0 - 2.0%Current NF
Viscosity (at 2% aqueous solution, Brookfield Rvf, spindle 3, speed 10 rpm, 25°C)400 - 800mPa.sBrookfield , PSM 101962
Alkaline Earth Metals (as calcium oxide)0.0 - 1.0%PSM 102225
Composition
ValueUnitsTest Method / Conditions
Silicon Dioxide Content0.8 - 3.0%PSM 101992
Butylated Hydroxytoluene Content100 - 1,000mg/kgPSM 102192
Free Ethylene Oxide Content0 - 1mg/kgPSM 102104
Heavy Metals
ValueUnitsTest Method / Conditions
Heavy Metals0.001wt.%-
Screen Test
ValueUnitsTest Method / Conditions
Screen (< 250 micron, through 60 mesh)96 - 100%PSM 102261
Note
  • The following specifications apply to sealed, unopened containers stored under the recommended conditions for the duration of the shelf life.
  • All section names come under PHS
  • * Audit Basis[AB]

Regulatory & Compliance

Packaging & Availability

Packaging Type