Norethindrone acetate (NA) and ethinyl estradiol (EE) related oxidative transformation products in stability samples of formulated drug product: synthesis of authentic references.

Abstract:

:Preparative chemical methods for the synthesis of eight oxidative transformation products of ethinyl estradiol (EE) and norethindrone acetate (NA) are described. The prepared materials are useful as reference materials and standards for pharmaceutical analysis of EE and NA as bulk chemical or in formulated product. All eight products result from oxidation of the A and/or B rings of the parent compounds. Oxidation of the heteroannular 3,5 dienyl acetate derivative of NA resulted in the 6 alpha-hydroxy, 6 beta-hydroxy and 6-keto NA. Oxidation of 6-keto NA led to the preparation of 6 alpha-hydroxy, 6 beta-hydroxy, 6-keto- and Delta(6) EE. Delta(11) EE was prepared from estrone.

journal_name

Steroids

journal_title

Steroids

authors

Ekhato IV,Hurley T,Lovdahl M,Revitte TJ,Guo L,Huang Y,Clipper S,Colson C

doi

10.1016/s0039-128x(01)00149-0

subject

Has Abstract

pub_date

2002-03-01 00:00:00

pages

165-74

issue

3-4

eissn

0039-128X

issn

1878-5867

pii

S0039128X01001490

journal_volume

67

pub_type

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