1. APIs
  2. Ethinyl Estradiol
  3. Impurities
  4. Estrone
  1. APIs
  2. Estradiol
  3. Impurities
  4. Estrone

Estrone

Structure

MOL SDF CML

Other Names & Identifiers

  • BP Ethinylestradiol Impurity C
  • BP Estradiol Hemihydrate Impurity A
  • BP Estradiol and Norethisterone Tablets Impurity A
  • BP Estradiol and Norethisterone Acetate Tablets Impurity A
  • Folliculin
  • Oestrone
  • Theelin
  • Estrovarin

CASRN

53-16-7

Molecular Formula

C18H22O2

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References

  1. Online Subscription Database. Reed Elsevier Properties SA. (View all citations for this reference)

Molecular Weight

270.371 g/mol

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References

  1. Online Subscription Database. Reed Elsevier Properties SA. (View all citations for this reference)

Melting Point

260.2° C

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References

  1. National Center for Biotechnology Information. PubChem Compound Database; CID=11150565. (View all citations for this reference)

Structural Difference from API

The C17 hydroxyl group of EE becomes a C17 carbonyl group in this impurity

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References

  1. BP 2015; vol. I, pages 903 - 905
    2. (View all citations for this reference)

Source from API

Oxidation of EE at C17; synthetic impurity

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References

  1. BP 2015; vol. I, pages 903 - 905
    2. (View all citations for this reference)

Reaxys ID

1915077

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References

  1. Online Subscription Database. Reed Elsevier Properties SA. (View all citations for this reference)

Limits

0.15%, 0.1% (EE)

References

  1. European Pharmacopoeia 8.2 Ethinyl Estradiol
    2. (View all citations for this reference)
  2. British Pharmacopoeia 2017: Estradiol and Norethisterone Acetate Tablets monograph.
    3. (View all citations for this reference)
  3. British Pharmacopoeia 2017: Estradiol and Norethisterone Tablets monograph.
    4. (View all citations for this reference)
  4. BP 2017 Estradiol Hemihydrate monograph.
    5. (View all citations for this reference)
  5. British Pharmacopoeia 2017: Ethinylestradiol monograph
    6. (View all citations for this reference)