Category
Duloxetine
CAS Number
Duloxetine STD - 116539-59-4 : IMP - C - 949095-98-1 : IMP - D - 90-15-3 : IMP - F - 959392-22-4 ;
Alternate CAS Number
136434-34-9(HCl Salt)
Molecular Formula
Duloxetine STD - C18H19NOS ,C18H20ClNOS (HCL), : IMP - C - C18H19NOS : IMP - D - C10H8O : IMP - F - C18H19NOS ;
Molecular Weight
Duloxetine STD - 297.42 g/mol , 333.9 g/mol (HCL), : IMP - C - 297.41 g/mol : IMP - D - 144.17 g/mol : IMP - F - 297.42 g/mol ;
Synonym

Duloxetine - (S)-Duloxetine; (+)-Duloxetine; (S)-(+)-N-Methyl-3-(1-naphthyloxy)-3-(2-thienyl)propylamine; (S)-N-Methyl-3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propan-1-amine;

Duloxetine EP Impurity C - 4-[(1RS)-3-(methylamino)-1-(thiophen-2-yl)propyl]naphthalen-1-ol; Naphthalen-1-ol, 4-[(1RS)-3-(methylamino)-1-(thiophen-2-yl)propyl]; 4-(3-(Methylamino)-1-(thiophen-2-yl)propyl)naphthalen-1-ol; Duloxetine Related Compound C;

Duloxetine EP Impurity D - naphthalen-1-ol ; 1-Naphthalenol; 1-Hydroxynaphthalene; 1-Naphthyl Alcohol; α-Naphthyl Alcohol; α-Hydroxynaphthalene; α-Naphthol; Naphthalen-1-ol (USP);

Duloxetine EP Impurity F - (3S)-N-methyl-3-(naphthalen-1-yloxy)-3-(thiophen-3-yl)propan-1-amine ; Duloxetine Impurity F (IP) ; Duloxetine Related Compound F (USP) ; 

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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.

Duloxetine CRS is used as a chemical reference standard for system suitability testing in chromatographic methods such as HPLC. It ensures proper performance of the analytical system by confirming accuracy, precision, and reproducibility before sample analysis.