SPL Set ID: de12f38c-ffa1-4d62-b9cb-238a263f6fea

Methylprednisolone acetate injectable suspension, USP is a sterile anti-inflammatory glucocorticoid for intramuscular, intra-articular, soft tissue, or intralesional injection. It is available in two strengths: 40 mg/mL and 80 mg/mL. Each mL of these preparations contains: Strengths 40 mg/mL 80 mg/mL Active: Methylprednisolone acetate, USP 40 mg 80 mg Inactives: Polyethylene glycol 3350 29.1 mg 28.2 mg Polysorbate 80 1.94 mg 1.88 mg Monobasic sodium phosphate 6.8 mg 6.59 mg Dibasic sodium phosphate 1.42 mg 1.37 mg Benzyl alcohol (added as preservative) 9.16 mg 8.88 mg Water for injection q.s. to 1 mL q.s. to 1 mL 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., 5.5 to 6.8). The chemical name for methylprednisolone acetate is pregna-1,4-diene-3,20-dione,21-(acetoxy)-11,17-dihydroxy-6-methyl,(6α,11ß) and the molecular weight is 416.51 g/mol. The structural formula is represented below: Molecular Formula: C 24 H 32 O 6 Methylprednisolone acetate injectable suspension USP, 400 mg/10 mL (40 mg/mL) and 400 mg/5 mL (80 mg/mL) contains methylprednisolone acetate, USP which is the 6-methyl derivative of prednisolone. Methylprednisolone acetate, USP is a white or almost white, odorless, crystalline powder which melts at about 213°C 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. structure