POLYOX™ WSR - 1105 LEO NF Grade

1 of 31 products in this brand
POLYOX™ WSR - 1105 LEO NF Grade an off-white powder, serves as a binder and thickener in cleaning agents. It is available in powder form and is water-soluble, making it suitable for use in 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 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), 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

Technical Data SheetSafety Data Sheet
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Enhanced TDS

Identification & Functionality

Chemical Family
Ethylene Oxide Copolymers
Chemical Name
Polyethylene Oxide
Ingredient Origin
Non-Animal Origin,
Plant Origin,
Synthetic
Pharma & Nutraceuticals Functions
Binder,
Controlled Release Agent
Technologies
Pharmaceuticals & Nutraceuticals
Product Families
Pharmaceuticals & Nutraceuticals — Excipients
Binders & Disintegrants,
Modified & Controlled Release

Features & Benefits

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 Tested on Animals,
Plant-Based,
Residual Solvent -Free,
Vegan,
Vegetarian

Applications & Uses

Markets
Healthcare & Pharma
Applications
Healthcare & Pharma — Drug Delivery & Care Solutions
Oral,
Topical
Segments
Pharmaceutical
Applications
Pharmaceutical — Controlled release
Dosage Form
Abuse Deterrent Tablets & Capsules,
Gels,
Osmotic Pump Tablet,
Tablets
Manufacturing Technology
Direct Compression

Properties

Physical Form
Powder
Soluble In
Water Soluble
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%, Brookfield)8,800 - 17,600mPa.sPSM 101962
Alkaline Earth Metals0.0 - 1.0%PSM 102225
Particle Size Distribution
ValueUnitsTest Method / Conditions
Particle Size (Screen <74 micron, through 200 mesh)0 - 40%PSM 102261
Particle Size (Screen <149 micron, through 100 mesh)35 - 75%PSM 102261
Particle Size (Screen <840 micron, through 20 mesh)96 - 100%PSM 102261
Particle Size (Screen <2000 micron, through 10 mesh)min. 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

Certifications & Compliance
Belgian Law And Codex Alimentarius Standards,
British Pharmacopeia (BP),
CFDA Compliant (China),
Chinese Pharmacopeia (ChP),
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)
Chemical Inventories
IECSC (China)