POLYOX™ WSR - 303 LEO NF Grade

1 of 31 products in this brand

POLYOX™ WSR - 303 LEO NF Grade with its off-white powdered form, serves various functions in cleaning ingredients, acting as a binder and thickener. It finds application in diverse dosage forms such as gels, osmotic pump tablets, and conventional tablets, leveraging its water solubility and facilitating controlled release in pharmaceutical and nutraceutical formulations, manufactured through direct compression technology.

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
Dosage Form: Abuse Deterrent Tablets & Capsules,
Gels,
Osmotic Pump Tablet,
Tablets
Manufacturing Technology: Direct Compression

Properties

Physical Form

Soluble In

Composition


	Value	Units	Test Method / Conditions
Silicon Dioxide Conent*	0.8 - 3.0	%	PSM 101992
Butylated Hydroxytoluene Content*	100 - 1,000	mg/Kg	PSM 102192
Free Ethylene Oxide*	0 - 1	mg/Kg	PSM 102104

Specifications


	Value	Units	Test Method / Conditions
pH (at 1% aqueous solution)*	8.0 - 10.0	-	PSM 102175
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 25 °C, Brookfield, 1%, Brookfield RVF, Spindle 2, Speed 2 RPM)*	7,500 - 10,000	mPa.s	PSM 101936

Heavy Metals


	Value	Units	Test Method / Conditions
Alkaline Earth Metals (as Calcium Oxide)*	0.0 - 1.0	%	PSM 102225
Heavy Metals*	0.001	wt%	-

Screen Test


	Value	Units	Test 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

*PHS - All section names come under PHS
[AB] = Audit Basis

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)
Quality Standards: GMP