Estrone Injectable Suspension
»Estrone Injectable Suspension is a sterile suspension of Estrone in Water for Injection.It contains not less than 90.0percent and not more than 115.0percent of the labeled amount of C18H22O2.
Packaging and storage—
Preserve in single-dose or in multiple-dose containers,preferably of Type Iglass.
Identification—
Transfer a volume of Injectable Suspension,equivalent to about 5mg of estrone,to a glass-stoppered centrifuge tube,and add 2.5mLof a mixture of ether and benzene (1:1).Shake for 2minutes,and allow insoluble matter to settle,centrifuging,if necessary,to obtain a clear supernatant.Apply 5µLeach of this supernatant and a 1in 500solution of USP Estrone RSin a mixture of ether and benzene (1:1)to a suitable thin-layer chromatographic plate (see Chromatography á621ñ),coated with a 0.25-mm layer of chromatographic silica gel.Allow the spots to dry,and develop the chromatogram in a solvent system consisting of a mixture of benzene and acetone (4:1)until the solvent front has moved about three-fourths of the length of the plate.Remove the plate from the developing chamber,mark the solvent front,and allow the solvent to evaporate.Spray the plate with a mixture of dehydrated alcohol and sulfuric acid (3:1),and heat in an oven at 105
for 10minutes:the RFvalue and appearance (pale orange to amber by direct observation in daylight,and fluorescing pale yellow-green under long-wavelength UVlight)of the principal spot obtained from the test solution correspond to those obtained from the Standard solution.
for 10minutes:the RFvalue and appearance (pale orange to amber by direct observation in daylight,and fluorescing pale yellow-green under long-wavelength UVlight)of the principal spot obtained from the test solution correspond to those obtained from the Standard solution.
Bacterial endotoxins á85ñ—
It contains not more than 88.0USP Endotoxin Units per mg of estrone.
Uniformity of dosage units á905ñ:
meets the requirements.
Other requirements—
It meets the requirements under Injections á1ñ.
Assay—
Mobile phase,Standard preparation,andChromatographic system—
Prepare as directed in the Assayunder Estrone.
Assay preparation—
Transfer an accurately measured volume of the well-mixed Injectable Suspension,equivalent to about 10mg of estrone to a 50-mLvolumetric flask.Add 30mLof methanol and swirl for 5minutes.Dilute with methanol to volume,and mix.Transfer 5.0mLof this solution to a 25-mLvolumetric flask,dilute with Mobile phaseto volume,and mix.
Auxiliary Information—
Staff Liaison:Clydewyn M.Anthony,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 781
Phone Number:1-301-816-8139