POLYOX™ WSR 301 SFP NF Grade - Specialty

1 of 29 products in this brand
POLYOX™ WSR 301 SFP NF Grade - Specialty 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 Glycol, Polyethylene Oxide, Pyrogenic Silica

CAS Number: 25322-68-3

Chemical Family: Ethylene Oxide Copolymers, Polyethers

Labeling Claims: Allergen-free, Chlorine-free, Dairy-free, Diethylene Glycol-free, Ethylene Glycol-free, Fungicide-free, Gluten-free, Herbicide-free, Nitrosamines-free, Not Tested on Animals, Pesticide-free, Residual Solvent -Free, Vegan, Vegetarian

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Enhanced TDS

Identification & Functionality

Features & Benefits

Applications & Uses

Properties

Physical Form
Soluble In
Physical Properties
ValueUnitsTest Method / Conditions
pH (at 1%, 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 1% aqueous solution, Brookfield Rvf, spindle 3, speed 10 rpm, 25°C)1,650 - 5,500mPa.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 (< 149 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