Category
Tofacitinib
CAS Number
2328165-36-0
Molecular Formula
C16H21N5O3
Molecular Weight
331.4 g/mol
Synonym

3-((3R,4R)-4-methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)piperidin-1-yl)-3-oxopropanoic acid ; Tofacitinib Impurity K ; 3-Oxopropanoic Acid,3-((3R,4R)-4-methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)piperidin-1-yl) ;

Keywords
Impurity Standards
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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.

Tofacitinib acid impurity is a process- or degradation-related impurity that may form during the synthesis or storage of tofacitinib. Monitoring and controlling this impurity is important to ensure the drug’s quality, safety, and compliance with pharmaceutical regulatory standards.