Category
Norethisterone
CAS Number
Norethisterone - STD - 68-22-4 ; IMP - A - 31528-46-8; IMP - B - 734-32-7 ; IMP - C - 22933-71-7 ; IMP - D - 68-23-5 ; IMP - E - 79727-03-0; IMP - F - 96487-85-3 ; IMP - G - 38673-36-8;
Molecular Formula
Norethisterone - STD - C20H26O2; IMP - A - C20H24O2 ; IMP - B - C18H24O2 ; IMP - C - C20H26O2 ; IMP - D - C20H26O2 ; IMP - E - C22H26O ; IMP - F - C22H30O2 ; IMP - G - C20H26O2 ;
Molecular Weight
Norethisterone - STD - 298.42 g/mol; IMP - A - 296.40 g/mol ; IMP - B - 272.38 g/mol ; IMP - C - 298.42 g/mol ; IMP - D - 298.42 g/mol ; IMP - E - 306.44 g/mol ; IMP - F - 326.47 g/mol ; IMP - G - 298.42 g/mol;
Synonym

Norethisterone -  (8R,9S,10R,13S,14S,17R)-17-ethynyl-17-hydroxy-13-methyl-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-1H-cyclopenta[a]phenanthren-3(2H)-one;Norethisterone;17alpha-Ethynyl-19-nortestosterone;

Norethisterone EP Impurity - A - (8R,9S,10R,13S,14S,17R)-17-ethynyl-17-hydroxy-13-methyl-8,9,10,11,12,13,14,15,16,17-decahydro-1H-cyclopenta[a]phenanthren-3(2H)-one ;6,7-Dehydro Norethindrone ; (17α)-17-Hydroxy-19-norpregna-4,6-dien-20-yn-3-one; 17-Hydroxy-19-nor-17α-pregna-4,6-dien-20-yn-3-one; 7α-Ethynyl-17β-hydroxyestra-4,6-dien-3-one; 6,7-Dehydronorethindrone;  

 Norethisterone EP Impurity - B - (8R,9S,10R,13S,14S)-13-Methyl-7,8,9,10,11,12,13,14,15,16-decahydro-1H-cyclopenta[a]phenanthrene-3,17(2H,6H)-dione ;  Estr-4-ene-3,17-dione;  (8R,9S,10R,13S,14S)-13-methyl-1,2,6,7,8,9,10,11,12,14,15,16-dodecahydrocyclopenta[a]phenanthrene-3,17-dione;Norethindrone Related Compound B (USP); 

Norethisterone EP Impurity - C - (8R,9S,10R,13S,14S,17R)-17-ethynyl-17-hydroxy-13-methyl-4,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-1H-cyclopenta[a]phenanthren-3(2H)-one ; (8R,9S,10R,13S,14S,17R)-17-ethynyl-17-hydroxy-13-methyl-1,2,4,7,8,9,10,11,12,14,15,16-dodecahydrocyclopenta[a]phenanthren-3-one ; Delta-5(6)-Norethindrone;

Norethisterone EP Impurity - D - 17beta-Hydroxy-17alpha-ethynylestr-5(10)-en-3-one; 17-Hydroxy-19-nor-17alpha-pregn-5(10)-en-20-yn-3-one; (17alpha)-17-hydroxy-19-Norpregn-5(10)-en-20-yn-3-one ;13-Methyl-17-ethynyl-17-hydroxy-1,2,3,4,6,7,8,9,11,12,13,14,16,17-tetradecahydro-15H-cyclopenta[a]phenanthren-3-one ;Norethindrone 5,10-Dehydro Impurity; 

Norethisterone EP Impurity - E - (8R,9S,10R,13S,14S,17R)-3,17-Diethynyl-13-methyl-2,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-1H-cyclopenta[a]phenanthren-17-ol;3-Ethynyl-19-norpregna-3,5-dien-20-yn-17beta-ol;(17alpha)-3-Ethynyl-19-norpregna-3,5-dien-20-yn-17-ol;3-Ethynyl-19-nor-17alpha-pregna-3,5-dien-20-yn-17-ol; 

Norethisterone EP Impurity - F - (8R,9S,10R,13S,14S,17R)-3-ethoxy-17-ethynyl-13-methyl-2,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-1H-cyclopenta[a]phenanthren-17-ol ;Norethindrone 3-Ethoxy Impurity ;Norethindrone 3-Ethyl Ether; 

Norethisterone EP Impurity - G -17-Hydroxy-19-norpregn-4-en-20-yn-3-one; 18-Methyllevonorgestrel; Norethisterone Impurity G (EP);   

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Purity:

Above - 95.0%

Technical Data:

We will provide complete documentation support for every Standard Material. All analytical reports such as ¹H NMR, ¹³C NMR, Mass, FT-IR, HPLC Purity/GC Purity/QNMR Purity, Water content by KF/ Loss on Drying/TGA (Thermo-gravimetric Analysis). Certificate of Analysis with potency report. Each Standard Material SER (Structure Elucidation Report) with NMR, Mass, IR spectral interpretation. This whole analytical document can be included in eCTD, ANDA, DMF submissions to regulatory agencies.

Norethisterone for system suitability CRS is used as a reference standard to confirm that the chromatographic system meets required performance criteria. It ensures reliable retention time, resolution, and peak shape before analysing norethisterone samples.