Octoxynol 9
;)
Poly(oxy-1,2-ethanediyl),a-(octylphenyl)-w-hydroxy-.
Polyethylene glycol mono(octylphenyl)ether [9002-93-1].
»Octoxynol 9is an anhydrous liquid mixture consisting chiefly of monooctylphenyl ethers of polyethylene glycols,corresponding to the formula:
C8H17C6H4(OCH2CH2)nOH,
in which the average value of nis about 9.
Packaging and storage—
Preserve in tight containers.
Identification,Infrared Absorption á197Fñ,on undried specimen.
Cloud point—
Weigh 1.00g into a 250-mLbeaker,and add 99g 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 63and 69.
.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 63and 69.
Hydroxyl value á401ñ:
between 85and 101.
Water,Method Iá921ñ:
not more than 0.5%.
Residue on ignition á281ñ:
not more than 0.4%.
Heavy metals á231ñ:
0.002%.
Free ethylene oxide—
Octoxynol 9meets the requirements for Free ethylene oxideunder Nonoxynol 9(see USPmonograph).In performing the test,substitute the term “Octoxynol 9”for “Nonoxynol 9”wherever it occurs.The limit is 5ppm.
Limit of dioxane—
It meets the requirements for Limit of dioxaneunder Nonoxynol 9(see USPmonograph).
Organic volatile impurities,Method IVá467ñ:
meets the requirements.
Auxiliary Information—
Staff Liaison:Karen A Russo,Ph.D.,Scientist
Expert Committee:(EMC)Excipients:Monograph Content
USP28–NF23Page 3042
Phone Number:1-301-816-8379