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 90.0 percent and not more than 110.0 percent of the labeled amount of methylprednisolone acetate (C24H32O6).
Packaging and storage Preserve in single-dose or in multiple-dose containers, preferably of Type I glass.
Identification, Infrared Absorption 197K Obtain the test specimen as follows. Filter a volume of Injectable Suspension, equivalent to about 100 mg of methylprednisolone acetate, through paper. Wash the residue with several 5-mL portions of water, and dry at 105 for 3 hours.
Uniformity of dosage units 905: meets the requirements.
pH 791: between 3.0 and 7.0.
Particle size Transfer 1 drop 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 20 µm in length when measured along the longest axis, and not less than 75% of the particles are less than 10 µm.
Other requirements It meets the requirements under Injections 1.
Mobile phase, Internal standard solution, Standard preparation, and Chromatographic system Proceed as directed in the Assay under 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 40 mg of methylprednisolone acetate, to a 25-mL volumetric flask, add 10.0 mL of Internal standard solution, dilute with chloroform to volume, and shake for about 15 minutes or until the aqueous layer is clear. Transfer 4.0 mL of the chloroform layer to a suitable vial, add 30 mL of chloroform and a small quantity (about 400 mg) of anhydrous sodium sulfate, shake for 5 minutes, and use the clear solution.
Procedure Proceed as directed for Procedure in the Assay under Methylprednisolone Acetate. Calculate the quantity, in mg, of methylprednisolone acetate (C24H32O6) in each mL of the Injectable Suspension taken by the formula:
(200C / V)(RU / RS)in which V is the volume, in mL, of Injectable Suspension taken, and the other terms are as defined therein.
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USP32NF27 Page 2954