Medroxyprogesterone

Structure

Other Names & Identifiers

  • BP MPA Impurity B
  • BP Medroxyprogesterone Injection Impurity B
  • BP Medroxyprogesterone Tablets Impurity B
  • 17-hydroxy-6α-methylpregn-4-ene-3,20-dione

CASRN

520-85-4

Molecular Formula

C22H32O3

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Molecular Weight

344.487 g/mol

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Structural Difference from API

The ester group is hydrolyzed to an OH group

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References

  1. British Pharmacopoeia 2017: Medroxyprogesterone Acetate monograph
  2. (View all citations for this reference)

Source of Impurity

produced from hydrolysis of MPA

References

Appearance

Crystals from chloroform

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Melting Point

214.5° C

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Water Solubility

2.95 mg/L at 25° C

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Organic Solubility

Very soluble in chloroform

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Predicted Octanol-Water Partition Coefficient (clogP)

3.50

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Specific Optical Rotation

+75° at 25 deg C/D in chloroform

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Vapor Pressure

1.93 x 10-10 mm Hg at 25° C

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Limits

0.7%

References

  1. British Pharmacopoeia 2014: Medroxyprogesterone Acetate API
  2. (View all citations for this reference)
  3. European Pharmacopoeia 8.0 Medroxyprogesterone Acetate API
  4. (View all citations for this reference)
  5. https://tripod.nih.gov/ginas/app/substance/45a8d9bd
  6. (View all citations for this reference)
  7. British Pharmacopoeia 2017: Medroxyprogesterone Acetate monograph
  8. (View all citations for this reference)
  9. British Pharmacopoeia 2017: Medroxyprogesterone Injection monograph
  10. (View all citations for this reference)
  11. British Pharmacopoeia 2017: Medroxyprogesterone Tablets monograph
  12. (View all citations for this reference)