(methylprednisolone acetate injectable suspension, USP)
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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:
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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