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DEPO-SUBQ PROVERA 104® (medroxyprogesterone acetate injectable suspension) Description

11 DESCRIPTION

Depo-subQ provera 104 contains medroxyprogesterone acetate (MPA), a derivative of progesterone, as its active ingredient. MPA is a white to off-white, odorless crystalline powder that is stable in air and that melts between 205°C and 209°C. It is freely soluble in chloroform, soluble in acetone and dioxane, sparingly soluble in alcohol and methanol, slightly soluble in ether, and insoluble in water.

The chemical name for MPA is 17-hydroxy-6α-methylpregn-4-ene-3,20-dione 17-acetate. The structural formula is as follows:

Chemical Structure

Depo-subQ provera 104 for subcutaneous use is available in pre-filled syringes, each containing 0.65 mL (104 mg) of sterile medroxyprogesterone acetate injectable suspension.

Each 0.65 mL contains the following inactive ingredients:

Methylparaben1.040 mg
Propylparaben0.098 mg
Sodium Chloride5.200 mg
Polyethylene Glycol18.688 mg
Polysorbate 801.950 mg
Monobasic Sodium Phosphate H2O0.451 mg
Dibasic Sodium Phosphate 12H2O0.382 mg
Methionine0.975 mg
Povidone3.250 mg
Water for Injectionqs

When necessary, the pH is adjusted with sodium hydroxide or hydrochloric acid, or both.

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