Milnacipran Impurities

General Information

Milnacipran Impurities and Milnacipran

Daicel Pharma offers the best-quality Milnacipran impurities and labeled standards. They are vital for evaluating Milnacipran quality, stability, and biological safety. Furthermore, Daicel Pharma specializes in the custom synthesis of Milnacipran impurities and ensures their worldwide delivery.

Milnacipran [CAS: 92623-85-3] belongs to a class of drugs, like serotonin and norepinephrine reuptake inhibitors (SNRIs). Levomilnacipran is the enantiomer of Milnacipran. It has fewer side effects compared to other tricyclic anti-depressants. It does not show neurological changes in the alpha1-adrenergic pathway.

Milnacipran: Use and Commercial Availability  

Milnacipran is a drug that treats patients with major depressive disorder (MDD) and fibromyalgia. It also treats pain disorders, including neuropathies. It improves fibromyalgia symptoms in patients. It is available as an oral formulation under Savella in the U.S. It is approved by the US FDA for the treatment of fibromyalgia. Milnacipran is sold globally under different brand names. In Japan, it is available as Toledomin and in Mexico, as Dalcipran.

Milnacipran Structure and Mechanism of Action

The chemical name of Milnacipran is (1R,2S)-rel-2-(Aminomethyl)-N, N-diethyl-1-phenylcyclopropanecarboxamide. The chemical formula for Milnacipran is C₁₅H₂₂N₂O, and its molecular weight is approximately 246.35 g/mol.

The precise mechanism of action of Milnacipran is unclear.

Milnacipran Impurities and Synthesis

Impurity formation during the synthesis of Milnacipran1 may affect the drug’s safety and efficacy. These impurities form during the manufacturing process, purification, or storage of Milnacipran. Therefore, Milnacipran impurities must be controlled and monitored throughout the drug’s development.
Daicel Pharma offers a comprehensive Certificate of Analysis (CoA) for Milnacipran impurities and labeled standards. We provide the CoA from a cGMP-compliant analytical facility. It gives complete characterization data2 such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity. We provide additional analytical data on request. Daicel Pharma can prepare any unidentified Milnacipran impurity or degradation product. In addition, Daicel Pharma offers highly purified, stable isotope-labeled standards, such as Dextro-milnacipran.HCl-D10, and Levo-milnacipran.HCl–D10. We provide a complete characterization report to clients on delivery.