POLYOX™ WSR - 301 LEO NF Grade

1 of 31 products in this brand
POLYOX™ WSR - 301 LEO NF Grade characterized by its off-white color, serves as a binder and thickener in cosmetic formulations. It is available in powder form and exhibits water solubility. Its versatility extends to various dosage forms including abuse deterrent tablets & capsules, gels, and osmotic pump tablets.

Chemical Name: Polyethylene Oxide

CAS Number: 25322-68-3

Functions: Binder, Controlled Release Agent, Film Former, Flocculant, Lubricant (Internal)

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, Halal, Heavy Metal-free, Kosher, Naturally Derived, Nitrosamines-free, No Added Formaldehyde, Non-GMO, Not Listed In California Proposition 65, Not Tested on Animals, Oxidatively Degradable, Plant-Based, Residual Solvent -Free, TSE-free, Vegan, Vegetarian, Zinc-free

Certifications & Compliance: Belgian Law And Codex Alimentarius Standards, British Pharmacopeia (BP), CFDA Compliant (China), 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.), FFDCA, GMP, Generally Recognized As Safe (GRAS), Halal, ICH Q3C, ICH Q3D, ISO 9001, Japan DMF, Japan Pharmacopeia (JP), Kosher, 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, US DMF, United States Pharmacopeia (USP)

Manufacturing Technology: Direct Compression

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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
Process Parameter 1min. 0.7-DWC-PX-1
Process Parameter 2 (Report)min. 0.0-DWC- PX-3
Loss on Drying0.0 - 1.0%PSM 102188
Residue on Ignition0.0 - 2.0%Current NF
Viscosity (at 1% aqueous solution, Brookfield)1,650 - 5,500mPa.sPSM 101962
Alkaline Earth Metals0.0 - 1.0%PSM 102225
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
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 2, speed 2 rpm, 25°C.
  • *[AB]
  • PHS - All section names come under PHS

Regulatory & Compliance

Packaging & Availability

Packaging Type