Methylprednisolone Acetate Injectable Suspension
»Methylprednisolone Acetate Injectable Suspension is a sterile suspension of Methylprednisolone Acetate in a suitable aqueous medium.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of methylprednisolone acetate (C24H32O6).
Packaging and storage— Preserve in single-dose or in multiple-dose containers,preferably of Type Iglass.
Identification,Infrared Absorption á197Kñ— Obtain the test specimen as follows.Filter a volume of Injectable Suspension,equivalent to about 100mg of methylprednisolone acetate,through paper.Wash the residue with several 5-mLportions of water,and dry at 105for 3hours.
Uniformity of dosage units á905ñ: meets the requirements.
pHá791ñ: between 3.0and 7.0.
Particle size— Transfer 1drop to a microscope slide,and spread evenly,diluting with water,if necessary,to decrease the density of the field.Examine the slide under a microscope,equipped with a calibrated ocular micrometer,using about 400×magnification.Scan the entire slide,and note the size of the individual particles:not less than 99%of the particles are less than 20µm in length when measured along the longest axis,and not less than 75%of the particles are less than 10µm.
Other requirements— It meets the requirements under Injections á1ñ.
Assay—
Mobile phase,Internal standard solution,Standard preparation,and Chromatographic system— Proceed as directed in the Assayunder Methylprednisolone Acetate.
Assay preparation— Swirl the Injectable Suspension to ensure uniformity prior to analysis.Transfer an accurately measured volume of Injectable Suspension,equivalent to about 40mg of methylprednisolone acetate,to a 25-mLvolumetric flask,add 10.0mLof Internal standard solution,dilute with chloroform to volume,and shake for about 15minutes or until the aqueous layer is clear.Transfer 4.0mLof the chloroform layer to a suitable vial,add 30mLof chloroform and a small quantity (about 400mg)of anhydrous sodium sulfate,shake for 5minutes,and use the clear solution.
Procedure— Proceed as directed for Procedurein the Assayunder Methylprednisolone Acetate.Calculate the quantity,in mg,of methylprednisolone acetate (C24H32O6)in each mLof the Injectable Suspension taken by the formula:
(200C/V)(RU/RS),
in which Vis the volume,in mL,of Injectable Suspension taken,and the other terms are as defined therein.
Auxiliary Information— Staff Liaison:Clydewyn M.Anthony,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 1270
Phone Number:1-301-816-8139