1. APIs
  2. Ethinyl Estradiol
  3. Impurities
  4. 4-Methyl-ethinylestradiol

4-Methyl-ethinylestradiol

Structure

MOL SDF CML

Other Names & Identifiers

  • BP Ethinylestradiol Impurity K
  • 4-methyl-19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol

CASRN

155683-61-7

Molecular Formula

C21H26O

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References

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

Molecular Weight

310.43 g/mol

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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 H group of EE's C4 is replaced with a methyl group in this impurity.

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References

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

Source from API

Possible synthetic side product, methylation of EE at C4.

References

PubChem CID

71587537

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References

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

Limits

0.2 % (EP 7.4)

References

  1. European Pharmacopoeia 8.2 Ethinyl Estradiol
    2. (View all citations for this reference)
  2. British Pharmacopoeia 2017: Ethinylestradiol monograph
    3. (View all citations for this reference)