POLYOX™ WSR - N80 NF Grade

1 of 31 products in this brand
POLYOX™ WSR - N80 NF Grade is an off-white to white powder that is water soluble. It is used in dosage forms such as abuse deterrent tablets, capsules, and gels, providing essential properties for these pharmaceutical applications.

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, Diethylene Glycol-free, Ethylene Glycol-free, Halal, Heavy Metal-free, Kosher, Naturally Derived, Nitrosamines-free, No Added Formaldehyde, Not Listed In California Proposition 65, Not Tested on Animals, Plant-Based, Residual Solvent -Free, Vegan, Vegetarian

Certifications & Compliance: Belgian Law And Codex Alimentarius Standards, British Pharmacopeia (BP), CFDA Compliant (China), Chinese Pharmacopeia (ChP), Clean Water Act (CWA) Certified, EXCiPACT, European Pharmacopeia (Ph. Eur.), GMP, Halal, ICH Q3C, ICH Q3D, Japan DMF, Japan Pharmacopeia (JP), Kosher, National Formulary (NF), US DMF, United States Pharmacopeia (USP)

Manufacturing Technology: Direct Compression

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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 5% aqueous solution, Brookfield)65 - 90mPa.sPSM 101962
Alkaline Earth Metals0.0 - 1.0%PSM 102225
Composition
ValueUnitsTest Method / Conditions
Silicon Dioxide Conent0.8 - 3.0%PSM 101992
Butylated Hydroxytoluene Content50 - 250mg/KgPSM 102192
Free Ethylene Oxide0 - 10mg/KgPSM 102104
Heavy Metals
ValueUnitsTest Method / Conditions
Heavy Metalsmax. 10ppm-
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
  • Alkaline earth metals as CaO.
  • Volatiles - 45 min at 105°C.
  • Residue on ignition = non-silicon dioxide.
  • Viscosity - Brookfield RVF, spindle 1, speed 50 rpm, 25°C.
  • PHS - All section names come under PHS
  • *[AB]

Regulatory & Compliance