POLYOX™ WSR Coagulant FP NF Grade

1 of 31 products in this brand
POLYOX™ WSR Coagulant FP NF Grade is an off-white to white powder that is water soluble. It is used in dosage forms such as abuse deterrent tablets, capsules, and gels, providing essential properties for these pharmaceutical applications.

Chemical Name: 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, 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

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Enhanced TDS

Identification & Functionality

Features & Benefits

Applications & Uses

Properties

Physical Form
Soluble In
Physical Properties
ValueUnitsTest Method / Conditions
pH (at 1% aqueous solution)8.0 - 10.0-PSM 102175
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
Specifications
ValueUnitsTest Method / Conditions
Identification (A,B)Pass-Current USP/EP/JP
Loss on Drying (at 105°C, 45 min)*0.0 - 1.0%PSM 102188
Residue on Ignition (non-silicon dioxide)0.0 - 2.0%Current NF
Viscosity (at 25 °C, Brookfield, at 1%, Brookfield RVF, Spindle 2, Speed 2 RPM)5,500 - 7,500mPa.sPSM 101936
Heavy Metals
ValueUnitsTest Method / Conditions
Alkaline Earth Metals0.0 - 1.0%PSM 102225
Heavy Metals0.001wt%-
Screen Test
ValueUnitsTest Method / Conditions
Screen (< 74 micron, through 200 mesh)min. 10%PSM 102261
Screen (< 149 micron, through 100 mesh)*min. 55%PSM 102261
Screen (< 250 micron, through 60 mesh)96 - 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