1. APIs
  2. Levonorgestrel
  3. Impurities
  4. 13-Ethyl-3-ethynyl-18,19-dinor-17α-pregna-3,5-dien-20-yn-17-ol

13-Ethyl-3-ethynyl-18,19-dinor-17α-pregna-3,5-dien-20-yn-17-ol

Structure

MOL SDF CML

Other Names & Identifiers

  • BP Levonorgestrel Impurity C

Structural Difference from API

ethynyl group at C3 instead of carbonyl; no double bond between C4 & C5 - instead double bonds between C3&C4 and C5 & C6

References

Source of Impurity

Synthetic side product formed during the ethinylation of the intermediate 3,17 dione

library_books

References

  1. Görög, S.; Babják, M.; Balogh, G.; Brlik, J.; Dravecz, F.; Gazdag, M.; Horváth, P.; Laukó, A.; Varga, K. Estimation of impurity profiles of drugs and related materials Part 19: Theme with variations. Identification of impurities in 3-oxosteroids. Journal of Pharmaceutical and Biomedical Analysis.1998, 18 (4), 511–525. 1998; 18:511-25.
    2. (View all citations for this reference)
  2. Horvath PB, G.; Brlik, J.; Csehi, A.; Dravecz, F.; Halmos, Z.; Lauko, A.; Renyei, M.; Varga, K.; Gorog, S. Estimation of impurity profiles of drugs and related materials .16. Identification of the side-products of the ethinylation step in the synthesis of contraceptive gestogens. Journal of Pharmaceutical and Biomedical Analysis. 1997; 15:1343-9.
    3. (View all citations for this reference)

Molecular Formula

C23H28O

References

Molecular Weight

320.47 g/mol

References

Limits

0.1%

References

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