Category
Dutasteride
CAS Number
Dutasteride STD - 164656-23-9 : IMP - A - 104239-97-6 : IMP - B - 2512195-98-9 : IMP - C - 157307-36-3 : IMP - E - 2102935-76-0 : IMP - F - 1365545-42-1 : IMP - G - 1430804-85-5 ;
Molecular Formula
Dutasteride STD - C27H30F6N2O2 : IMP - A - C19H27NO3 : IMP - B - C21H32N2O2 : IMP - C - C21H31NO3 : IMP - E - C27H30F6N2O2 : IMP - F - C27H31ClF6N2O2 : IMP - G - C27H28F6N2O2 ;
Molecular Weight
Dutasteride STD - 528.5 g/mol : IMP - A - 317.42 g/mol : IMP - B - 344.49 g/mol : IMP - C - 345.48 g/mol : IMP - E - 528.53 g/mol : IMP - F - 564.99 g/mol : IMP - G - 526.51 g/mol ;
Synonym

Dutasteride - N-[2,5-Bis(trifluoromethyl)phenyl]-3-oxo-4-aza-5a-androst1-ene-17beta-carboxamide ;(5alpha,17beta)-N-[2,5-Bis(trifluoromethyl)phenyl]-3-oxo-4-azaandrost-1-ene-17-carboxamide;

Dutasteride EP Impurity A - 3-oxo-4-aza-5a-androst-1-ene-17beta-carboxylic acid ; (4aR,4bS,6aS,7S,9aS,9bS,11aR)-4a,6a-Dimethyl-2-oxo-2,4a,4b,5,6,6a,7,8,9,9a,9b,10,11,11a-tetradecahydro-1H-indeno[5,4-f]quinoline-7-carboxylic Acid;

Dutasteride EP Impurity B - N,N-dimethyl-3-oxo-4-aza-5α-androst-1-ene-17βcarboxamide ;

Dutasteride EP Impurity C - Ethyl 3-Oxo-4-aza-5α-androst-1-ene-17β-carboxylate; (4aR,4bS,6aS,7S,9aS,9bS,11aR)-2,4a,4b,5,6,6a,7,8,9,9a,9b,10,11,11a-Tetradecahydro-4a,6a-dimethyl-2-oxo-1H-Indeno[5,4-f]quinoline-7-carboxylic Acid Ethyl Ester ;

Dutasteride EP Impurity E - N-[2,5-bis(trifluoromethyl)phenyl]-3-oxo-4-aza-5aandrost-1-ene-17a-carboxamide ;

Dutasteride EP Impurity F - N-[2,5-bis(trifluoromethyl)phenyl]-1α-chloro-3-oxo-4-aza5α-androstane-17β-carboxamide ;

Dutasteride  EP Impurity G - N-[2,5-bis(trifluoromethyl)phenyl]-3-oxo-4-azaandrost1,5-diene-17beta-carboxamide; 

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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.

Dutasteride CRS is used as a chemical reference standard to verify system suitability in chromatographic methods (e.g., HPLC).It ensures accuracy, precision, and resolution of the analytical system before sample analysis.