Teriflunomide is a disease-modifying therapy (DMT) used to treat relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS. It works by reducing the number of relapses and slowing disease progression. Teriflunomide is an oral immunomodulatory drug and is marketed under the brand name Aubagio.
Parent: Teriflunomide
Parent: Teriflunomide
Parent: Teriflunomide
Parent: Teriflunomide
Parent: Teriflunomide
Parent: Teriflunomide
Parent: Teriflunomide
Parent: Teriflunomide
Impurities in Teriflunomide can arise due to chemical synthesis, degradation, or improper storage conditions. Regulatory agencies such as the FDA, EMA, and ICH enforce impurity limits to ensure drug safety and efficacy.
Process-Related Impurities
• Unreacted intermediates from chemical synthesis
• Residual solvents (e.g., methanol, ethanol, dichloromethane)
• By-products from the manufacturing process
Degradation Impurities
• Oxidation products due to exposure to oxygen or light
• Hydrolysis impurities caused by moisture
• Thermal degradation products at high temperatures
Elemental Impurities
• Heavy metals from catalysts used in synthesis
• Trace levels of arsenic, cadmium, lead, and mercury
Analytical Techniques for Impurity Detection
• High-Performance Liquid Chromatography (HPLC)
• Gas Chromatography (GC)
• Mass Spectrometry (MS)
• Fourier-Transform Infrared Spectroscopy (FT-IR)
Yes, Teriflunomide is a disease-modifying therapy (DMT) for multiple sclerosis. It helps reduce the frequency of relapses and slow down disability progression in relapsing forms of MS.
Teriflunomide is an immunomodulator, meaning it modifies the immune system rather than completely suppressing it. It reduces immune cell proliferation to decrease inflammation in MS but does not completely shut down the immune response like traditional immunosuppressants.
Teriflunomide works by inhibiting dihydroorotate dehydrogenase (DHODH), an enzyme essential for pyrimidine synthesis in rapidly dividing immune cells (T and B lymphocytes). This reduces their proliferation and limits the autoimmune attack on myelin, which is a hallmark of MS.
Yes, Teriflunomide is the active ingredient in Aubagio. Aubagio is the brand name under which Teriflunomide is marketed for the treatment of relapsing MS.
