Medroxyprogesterone Acetate Injectable Suspension
»Medroxyprogesterone Acetate Injectable Suspension is a sterile suspension of Medroxyprogesterone Acetate in a suitable aqueous medium.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of medroxyprogesterone acetate (C24H34O4).
Packaging and storage— Preserve in single-dose or multiple-dose containers,preferably of Type Iglass.
Identification— Transfer a volume of Injectable Suspension,equivalent to about 50mg of medroxyprogesterone acetate,to a centrifuge tube,centrifuge,decant the supernatant,and wash the solids with two 15-mLportions of water,discarding the water washings.Dissolve the solids in 10mLof chloroform,transfer to a small beaker,evaporate the chloroform on a steam bath,and dry at 105for 3hours:the residue so obtained responds to Identificationtest Aunder Medroxyprogesterone Acetate.
pHá791ñ: between 3.0and 7.0.
Other requirements— It meets the requirements under Injections á1ñ.
Assay—
Mobile phase— Mix 700mLof butyl chloride,300mLof hexane,both previously saturated with water,and 80mLof acetonitrile.The acetonitrile concentration may be varied to meet system suitability requirements and to provide elution times of about 12and 15minutes for progesterone and medroxyprogesterone acetate,respectively.Pass the solution through a membrane filter (1µm or finer porosity).
Internal standard solution— Prepare a solution of progesterone in Mobile phasecontaining 0.25mg per mL.
Standard preparation— Dissolve about 8mg of USP Medroxyprogesterone Acetate RS,accurately weighed,in 20.0mLof Internal standard solution.
Assay preparation— Transfer to a suitable container an accurately measured volume of Injectable Suspension,equivalent to about 50mg of medroxyprogesterone acetate.Pipet 25mLof chloroform into the container,shake for about 20minutes,and centrifuge.Pipet 4mLof the chloroform layer into a suitable container,and evaporate to dryness.Pipet 20mLof Internal standard solutioninto the container to dissolve the residue.
Chromatographic system— The liquid chromatograph is equipped with a 254-nm detector and a 2-mm ×25-cm column that contains 5-µm packing L3.The flow rate is about 2mLper minute.Chromatograph the Standard preparation,and record the peak responses as directed for Procedure:the resolution of progesterone and medroxyprogesterone is not less than 5.0,and the relative standard deviation of the peak responses for replicate injections is not more than 2.0%.
Procedure— Proceed as directed in the Assayunder Medroxyprogesterone Acetate.Calculate the quantity,in mg,of medroxyprogeterone acetate (C24H34O4)in each mLof the Injectable Suspension taken by the formula:
125(C/V)(RU/RS),
in which Cis the concentration,in mg,of USP Medroxyprogesterone Acetate RSin the Standard preparation;Vis the volume,in mL,of Injectable Suspension taken;and RUand RSare the ratios of peak areas of medroxyprogesterone acetate peak to internal standard peak obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Clydewyn M.Anthony,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 1197
Phone Number:1-301-816-8139