POLYOX™ WSR - N60K SFP NF Grade

1 of 31 products in this brand
POLYOX™ WSR - N60K SFP NF Grade an off-white powder, offers versatile applications. Its industrial additives function as binders and thickeners, aiding in direct compression manufacturing. In pharmaceuticals, it acts as a binder and controlled release agent. Soluble in water, it suits abuse deterrent tablets & capsules, gels, and osmotic pump tablets.

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
Typical Properties
ValueUnitsTest Method / Conditions
pH (at 2% solution)8.0 - 10.0-PSM 102175
Identification (A,B)*Pass-Current USP/EP/JP
Loss on Drying0 - 1%PSM 102188
Residue on Ignition0 - 2%Current NF
Alkaline Earth Metals0.0 - 1.0%PSM 102225
Viscosity (at 2%, Brookfield)2,000 - 4,000mPa.sPSM 101962
Particle Size Distribution
ValueUnitsTest Method / Conditions
Particle Size (Screen <149 micron, through 100 mesh)96 - 100%PSM 102261
Composition
ValueUnitsTest Method / Conditions
Silicon Dioxide Conent0.8 - 3.0%PSM 101992
Butylated Hydroxytoluene Content100 - 1,000mg/KgPSM 102192
Free Ethylene Oxide0 - 1mg/KgPSM 102104
Note
  • * -  Audit Basis (AB)
  • PHS - All section names come under PHS
  • Alkaline earth metals as CaO.
  • Volatiles - 45 min at 105 deg C.
  • Residue on ignition = non-silicon dioxide.
  • Viscosity - Brookfield RVF, spindle 2, speed 2 rpm, 25 deg C.

Regulatory & Compliance