POLYOX™ WSR - 205 FP NF Grade

1 of 31 products in this brand
POLYOX™ WSR - 205 FP NF Grade comprising ethylene oxide copolymers and polyethylene oxide (PEG-14M), serves multiple functions across various pharmaceutical applications. Its versatility extends to deterrent tablets and capsules, gels, osmotic pump tablets, and regular tablets. Functioning as a binder and thickener, it ensures optimal formulation performance. Available in powder form, it exhibits water solubility, facilitating ease of use in 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, Dairy-free, Diethylene Glycol-free, Ethylene Glycol-free, Fungicide-free, Gluten-free, Herbicide-free, Nitrosamines-free, Not Listed In California Proposition 65, Not Tested on Animals, Pesticide-free, Residual Solvent -Free, Vegan, Vegetarian

Certifications & Compliance: Belgian Law And Codex Alimentarius Standards, British Pharmacopeia (BP), Chinese Pharmacopeia (ChP), Clean Water Act (CWA) Certified, EXCiPACT, European Pharmacopeia (Ph. Eur.), FDA Compliant, ICH Q3C, Japan Pharmacopeia (JP), National Formulary (NF), 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 5%, 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)4,500 - 8,800mPa.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