DEPO-PROVERA Sterile Aqueous Suspension contains medroxyprogesterone acetate, which is a derivative of progesterone and is active by the parenteral and oral routes of administration. It is a white to off-white, odorless crystalline powder, stable in air, melting between 200° and 210° C. It is freely soluble in chloroform, soluble in acetone and in dioxane, sparingly soluble in alcohol and methanol, slightly soluble in ether and insoluble in water.
The chemical name for medroxyprogesterone acetate is Pregn-4-ene-3, 20-dione, 17-(acetyloxy)-6-methyl-, (6α)-. The structural formula is:
DEPO-PROVERA for intramuscular injection is available as 400 mg/mL medroxyprogesterone acetate. Each mL of the 400 mg/mL suspension contains:
|Medroxyprogesterone acetate||400 mg|
|Polyethylene glycol 3350||20.3 mg|
|Sodium sulfate anhydrous||11 mg|
|Myristyl-gamma-picolinium chloride||1.69 mg|
|added as preservative|
When necessary, pH was adjusted with sodium hydroxide and/or hydrochloric acid.