POLYOX™ N60K LEO NF HV

1 of 31 products in this brand
POLYOX™ N60K LEO NF HV containing polyethylene oxide (PEG-45M) serves multiple functions in various applications. Its versatility extends to deterrent tablets and capsules, gels, osmotic pump tablets, and regular tablets. Functioning as a thickener, binder, and controlled release agent, it ensures optimal formulation performance. Available in powder form, it exhibits water solubility, enhancing its usability in diverse pharmaceutical formulations.

Chemical Name: Polyethylene Glycol, Polyethylene Oxide, Pyrogenic Silica

CAS Number: 25322-68-3

Dosage Form: Abuse Deterrent Tablets & Capsules, Gels, Osmotic Pump Tablet, Tablets

Labeling Claims: Allergen-free, Chlorine-free, Dairy-free, Diethylene Glycol-free, Ethylene Glycol-free, Fungicide-free, Gluten-free, Herbicide-free, Nitrosamines-free, Not Tested on Animals, Pesticide-free, Residual Solvent -Free, Vegan, Vegetarian

Certifications & Compliance: Belgian Law And Codex Alimentarius Standards, British Pharmacopeia (BP), Chinese Pharmacopeia (ChP), EC No.1907/2006, EXCiPACT, European Pharmacopeia (Ph. Eur.), FDA Compliant, ICH Q3C, Japan Pharmacopeia (JP), National Formulary (NF), United States Pharmacopeia (USP)

Technical Data SheetSafety Data Sheet
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Enhanced TDS

Identification & Functionality

Chemical Family
Ethylene Oxide Copolymers,
Polyethers
Chemical Name
Polyethylene Glycol,
Polyethylene Oxide,
Pyrogenic Silica
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,
Dairy-free,
Diethylene Glycol-free,
Ethylene Glycol-free,
Fungicide-free,
Gluten-free,
Herbicide-free,
Nitrosamines-free,
Not Tested on Animals,
Pesticide-free,
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

Properties

Physical Form
Powder
Soluble In
Water Soluble
Physical Properties
ValueUnitsTest Method / Conditions
pH (at 2%, 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 2% aqueous solution, Brookfield Rvf, spindle 3, speed 10 rpm, 25°C)3,000 - 4,000mPa.sBrookfield , PSM 101962
Alkaline Earth Metals (as calcium oxide)0.0 - 1.0%PSM 102225
Composition
ValueUnitsTest Method / Conditions
Silicon Dioxide Content0.8 - 3.0%PSM 101992
Butylated Hydroxytoluene Content100 - 1,000mg/kgPSM 102192
Free Ethylene Oxide Content0 - 1mg/kgPSM 102104
Heavy Metals
ValueUnitsTest Method / Conditions
Heavy Metals0.001wt.%-
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
  • The following specifications apply to sealed, unopened containers stored under the recommended conditions for the duration of the shelf life.
  • All section names come under PHS
  • * Audit Basis[AB]

Regulatory & Compliance

Certifications & Compliance
Belgian Law And Codex Alimentarius Standards,
British Pharmacopeia (BP),
Chinese Pharmacopeia (ChP),
EC No.1907/2006,
EXCiPACT,
European Pharmacopeia (Ph. Eur.),
FDA Compliant,
ICH Q3C,
Japan Pharmacopeia (JP),
National Formulary (NF),
United States Pharmacopeia (USP)
Chemical Inventories
AICS (Australia),
DSL (Canada),
ENCS (Japan),
IECSC (China),
KECI (Korea),
NDSL (Canada),
PICCS (Phillipines)