1. APIs
  2. Norethindrone
  3. Impurities
  4. Norandrostenedione
  1. APIs
  2. Norethindrone Acetate
  3. Impurities
  4. Norandrostenedione

Norandrostenedione

Structure

Other Names & Identifiers

  • BP Norethisterone Impurity B
  • BP Norethisterone Acetate Impurity J
  • estra-4-ene-3,17-dione
  • 4-oestrene-3,17-dione
  • Impurity 2 (Gorog 1987)

Notes

19-norandrostenedione. Intermediate in the synthesis of norethindrone. Impurity in norethindrone (EP 8.2 Impurity B) and norethindrone acetate (EP 8.2 Impurity J). Anabolic steroid: use by athletes is banned.

Spectra

HPLC, UV

library_books

References

  1. Gorog SH, B. Analysis of Steroids. 38. The use of high-performance liquid chromatography with diode-array UV detection for estimating impurity profiles of steroid drugs. Journal of Chromatography. 1987; 400:177-86.
    2. (View all citations for this reference)

Spectra

LC-MS/MS

library_books

References

  1. Walker CJC, D. A.; James, V. H. T.; Lau, J. C. Y.; Kicman, A. T. Doping in sport-2. Quantification of the impurity 19-norandrostenedione in pharmaceutical preparations of norethisterone. Steroids. 2009; 74:335-40.
    2. (View all citations for this reference)

Spectra

LC, UV 254 nm

library_books

References

  1. British Pharmacopoeia 2014: Norethisterone API
    2. (View all citations for this reference)
  2. European Pharmacopoeia 8.2 Norethisterone
    3. (View all citations for this reference)

Limits

0.1% (NET, NETA)

References

  1. Gorog SH, B. Analysis of Steroids. 38. The use of high-performance liquid chromatography with diode-array UV detection for estimating impurity profiles of steroid drugs. Journal of Chromatography. 1987; 400:177-86.
    2. (View all citations for this reference)
  2. European Pharmacopoeia 8.2 Norethisterone
    3. (View all citations for this reference)
  3. British Pharmacopoeia 2014: Norethisterone API
    4. (View all citations for this reference)
  4. Walker CJC, D. A.; James, V. H. T.; Lau, J. C. Y.; Kicman, A. T. Doping in sport-2. Quantification of the impurity 19-norandrostenedione in pharmaceutical preparations of norethisterone. Steroids. 2009; 74:335-40.
    5. (View all citations for this reference)
  5. British Pharmacopoeia 2017: Norethisterone monograph.
    6. (View all citations for this reference)