1. APIs
  2. Levonorgestrel
  3. Impurities
  4. 10β-Hydroxylevonorgestrel

10β-Hydroxylevonorgestrel

Structure

MOL SDF CML

Other Names & Identifiers

  • BP Levonorgestrel Impurity I
  • 13-ethyl-10,17-dihydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one

CASRN

21508-50-9

Molecular Formula

C21H28O3

References

Molecular Weight

328.54 g/mol

References

Source of Impurity

Formed through oxidation of final product and/or intermediates

library_books

References

  1. Gorog SB, M.; Csizer, E.; Dravetz, F.; Gazdag, M.; Herenyi, B. Estimation of impurity profiles of drugs and related materials .14. The role of HPLC/diode-array UV spectroscopy in the identification of minor components (impurities, degradation products, metabolites) in various matrices. Journal of Pharmaceutical and Biomedical Analysis. 1995; 14:85-92.
    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)

Limits

0.1%

References

  1. British Pharmacopoeia 2017: Levonorgestrel monograph.
    2. (View all citations for this reference)
  2. Berta, R.; Babjak, M.; Gazdag, M. A Study of Some Practical Aspects of High Temperature Liquid Chromatography in Pharmaceutical Applications. J. Pharm. Biomed. Anal. 2011, 54 (3), 458–462.
    3. (View all citations for this reference)