Poly(oxy-1,2-ethanediyl), -(octylphenyl)--hydroxy-.
Polyethylene glycol mono(octylphenyl) ether [9002-93-1].

Packaging and storage— Preserve in tight containers.

USP Reference standards 11— USP Octoxynol 9 RS.

Identification, Infrared Absorption 197F, on undried specimen.

Cloud point— Weigh 1.00 g into a 250-mL beaker, and add 99 g of water. Dissolve completely by careful heating, while stirring at a constant slow speed with a small-propeller-blade stirrer. Center a thermometer vertically in the solution, and heat rapidly until the entire solution becomes cloudy, then raise the temperature 10. Remove the source of heat, continue stirring, and record the temperature at which the solution becomes sufficiently clear to permit seeing the entire thermometer bulb plainly: the cloud point is between 63 and 69.

Hydroxyl value 401: between 85 and 101.

Water, Method I 921: not more than 0.5%.

Residue on ignition 281: not more than 0.4%.

Heavy metals 231: 0.002%.

Free ethylene oxide— Octoxynol 9 meets the requirements for Free ethylene oxide under Nonoxynol 9 (see USP monograph). In performing the test, substitute the term “Octoxynol 9” for “Nonoxynol 9” wherever it occurs. The limit is 5 ppm.

Limit of dioxane— It meets the requirements for Limit of dioxane under Nonoxynol 9 (see USP monograph).

Organic volatile impurities, Method IV 467: meets the requirements.

Residual solvents 467: meets the requirements.

Expert Committee : (EM205) Excipient Monographs 2

USP29–NF24 Page 3381

Phone Number : 1-301-816-8351