باب
Norgestrel
رقم CAS
Norgestrel -STD - 6533-00-2 ; IMP - A-110785-09-6 ; IMP - B-1095-74-5 ; IMP - E -N/A; IMP - G - N/A ;
الصيغة الجزيئية
Norgestrel -STD - C21H28O2 ; IMP - A- C21H26O2; IMP - B- C21H28O2 ; IMP - E- C21H26O2; IMP - G-C21H28O2 ;
وزن جزيئي
Norgestrel -STD - 312.45 g/mol ; IMP - A- 310.44 g/mol ; IMP - B - 312.45 g/mol ; IMP - E -310.43 g/mol; IMP - G-312.4 g/mol
مرادف

Norgestrel - (8R,9S,10R,13S,14S)-13-Ethyl-17-ethynyl-17-hydroxy-1,2,6,7,8,9,10,11,12,13,14,15,16,17-tetradecahydro-3H-cyclopenta[a]phenanthren-3-one; 

Norgestrel EP Impurity - A -(17Alpha)-(±)-13-Ethyl-17-hydroxy-18,19-dinorpregna-4,8(14)-dien-20-yn-3-one; 18,19-Dinorpregna-4,8(14)-dien-20-yn-3-one, 13-ethyl-17-hydroxy-, (17a)-(±) ;

Norgestrel EP Impurity - B - 18,19-Dinorpregn-5(10)-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17a)-(±); 

Norgestrel EP Impurity - E - (8R,9S,10R,13S,14S,17R)-13-ethyl-17-ethynyl-17-hydroxy-8,9,10,11,12,13,14,15,16,17-decahydro-1H-cyclopenta[a]phenanthren-3(2H)-one ;

Norgestrel EP Impurity - G - (8R,9S,10R,13S,14S,17R)-13-ethyl-17-ethynyl-17-hydroxy-4,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-1H-cyclopenta[a]phenanthren-3(2H)-one;

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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.

Norgestrel for system suitability CRS is used as a reference standard to verify chromatographic system performance, ensuring accurate and reliable identification and quantification in analytical testing.