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DEPO-PROVERA® 400 (medroxyprogesterone acetate - DEPO-PROVERA 400) Description

DESCRIPTION

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:

Chemical Structure

medroxyprogesterone acetate

DEPO-PROVERA for intramuscular injection is available as 400 mg/mL medroxyprogesterone acetate. Each mL of the 400 mg/mL suspension contains:

Medroxyprogesterone acetate400 mg
Polyethylene glycol 335020.3 mg
Sodium sulfate anhydrous 11 mg
  with
Myristyl-gamma-picolinium chloride1.69 mg
  added as preservative

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

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