POLYOX™ WSR - N10 LEO NF Grade

1 of 31 products in this brand

POLYOX™ WSR - N10 LEO NF Grade an off-white powder, is prized for its water solubility, making it an effective binder and thickener in both cleaning and cosmetic products. Its versatility and solubility make it a valuable ingredient for various formulations.

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 Sheet Safety Data Sheet

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Enhanced TDS

Identification & Functionality

Chemical Family: Ethylene Oxide Copolymers,
Polyethers
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
Pharmaceutical — Immediate release
Dosage Form: Abuse Deterrent Tablets & Capsules,
Gels,
Osmotic Pump Tablet,
Tablets
Manufacturing Technology: Direct Compression

Properties

Physical Form

Soluble In

Physical Properties


	Value	Units	Test Method / Conditions
pH (at 5% aqueous solution)	8.0 - 10.0	-	PSM 102175

Typical Properties


	Value	Units	Test Method / Conditions
Identification (A,B)*	Pass	-	Current USP/EP/JP
Loss on Drying	0.0 - 1.0	%	PSM 102188
Residue on Ignition	0.0 - 2.0	%	Current NF
Viscosity (at 5%, Brookfield)	30 - 50	mPa.s	PSM 101962
Alkaline Earth Metals	0.0 - 1.0	%	PSM 102225

Particle Size Distribution


	Value	Units	Test 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


	Value	Units	Test Method / Conditions
Silicon Dioxide Conent	0.8 - 3.0	%	PSM 101992
Butylated Hydroxytoluene Content	50 - 250	mg/Kg	PSM 102192
Free Ethylene Oxide	0 - 1	mg/Kg	PSM 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)
Quality Standards: GMP