POLYOX™ WSR N 80NF TG LEO

1 of 31 products in this brand
POLYOX™ WSR N 80NF TG LEO, in an off-white powder form, serves as a binder and thickener in cleaning and pharmaceutical formulations. Its water solubility makes it suitable for various applications, while its direct compression manufacturing technology ensures efficient production processes. Additionally, it functions as a controlled release agent, adding value to pharmaceutical formulations.

Chemical Name: Polyethylene Oxide

CAS Number: 25322-68-3

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

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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Enhanced TDS

Identification & Functionality

Features & Benefits

Applications & Uses

Properties

Physical Form
Soluble In
Appearance
Pass
Physical Properties
ValueUnitsTest Method / Conditions
pH (at 5% aqueous solution)*8.0 - 10.0-PSM 102175
Composition
ValueUnitsTest Method / Conditions
Silicon Dioxide Conent*0.8 - 3.0%PSM 101992
Butylated Hydroxytoluene Content*50 - 150mg/KgPSM 102192
Free Ethylene Oxide*0 - 1mg/KgPSM 102104
Specifications
ValueUnitsTest Method / Conditions
Identification (A,B)*Pass-Current USP/EP/JP
Organic Volatile Impurities*Pass-Current USP Organic Volatile Impurities
Loss on Drying (at 105°C, 45 min)*0.0 - 1.0%PSM 102188
Residue on Ignition*0.0 - 2.0%Current NF
Viscosity (at 25 °C, Brookfield. at 5%, Brookfield RVF, Spindle 1, Speed 50 RPM)*70 - 90mPa.sPSM 101936
Heavy Metals
ValueUnitsTest Method / Conditions
Alkaline Earth Metals (Calcium Hydroxide)*0.0 - 1.0%PSM 102225
Screen Test
ValueUnitsTest Method / Conditions
Screen (< 74 micron, through 200 mesh)*0 - 40%PSM 102261
Screen (< 149 micron, through 100 mesh)*40 - 70%PSM 102261
Screen (< 840 micron, through 20 mesh)*96 - 100%PSM 102261
Screen (< 2000 micron, through 10 mesh)*min. 100%PSM 102261
Note

*NF and Ph. Eur. ID tests; “A” and “B” on a quarterly basis. ID tests “C” (NF and Ph. Eur.) and “D” (Ph.Eur.) will be completed by exception only.

Regulatory & Compliance

Packaging & Availability

Packaging Type