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DEPO-MEDROL® Multi-dose Vial (methylprednisolone acetate injectable suspension, USP) Description

DESCRIPTION

DEPO-MEDROL is an anti-inflammatory glucocorticoid for intramuscular, intra-articular, soft tissue, or intralesional injection. It is available in three strengths: 20 mg/mL, 40 mg/mL, 80 mg/mL.

Each mL of these preparations contains:

Methylprednisolone acetate 20 mg 40 mg 80 mg
Polyethylene glycol 3350 29.5 mg 29.1 mg 28.2 mg
Polysorbate 80 1.97 mg 1.94 mg 1.88 mg
Monobasic sodium phosphate 6.9 mg 6.8 mg 6.59 mg
Dibasic sodium phosphate USP 1.44 mg 1.42 mg 1.37 mg
Benzyl alcohol added as a preservative 9.3 mg 9.16 mg 8.88 mg

Sodium Chloride was added to adjust tonicity.

When necessary, pH was adjusted with sodium hydroxide and/or hydrochloric acid.

The pH of the finished product remains within the USP specified range (e.g., 3.5 to 7.0).

The chemical name for methylprednisolone acetate is pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-11,17-dihydroxy-6-methyl-,(6α,11ß)- and the molecular weight is 416.51. The structural formula is represented below:

Chemical Structure

DEPO-MEDROL Sterile Aqueous Suspension contains methylprednisolone acetate which is the 6-methyl derivative of prednisolone. Methylprednisolone acetate is a white or practically white, odorless, crystalline powder which melts at about 215° with some decomposition. It is soluble in dioxane, sparingly soluble in acetone, alcohol, chloroform, and methanol, and slightly soluble in ether. It is practically insoluble in water.

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