Mirogabalin

General Information

Mirogabalin Impurities and Mirogabalin

Daicel Pharma offers superior-quality Mirogabalin impurities, such as Mirogabalin Enantiomer, Mirogabalin Lactam Impurity, and Racemic Mixture of Mirogabalin (Benzene sulfonic acid salt). These impurities are essential for evaluating Mirogabalin quality, stability, and biological safety. In addition, Daicel Pharma specializes in the custom synthesis of Mirogabalin impurities and ensures their worldwide delivery.

Mirogabalin [CAS: 1138245-13-2] is a gabapentinoid drug. Initially, it was made to treat refractory epilepsy. Now, it has been developed by Daiichi Sankyo and manages peripheral neuropathic pain. It has analgesic, anxiolytic, and anticonvulsant properties. It weakens neuronal hyperexcitability in the brain and spinal cord.

Mirogabalin: Use and Commercial Availability  

Mirogabalin1 treats postherpetic neuralgia and diabetic peripheral neuropathy in patients. It manages peripheral neuropathic pain and sustained analgesia. Many companies got approval in several countries to manufacture Mirogabalin. The numerous brand names include Merolin, Gabafix, Miraba, Neuramend, etc. Daiichi Sankyo sells Mirogabalin as an oral formulation under Tarlige.

Mirogabalin Structure and Mechanism of Action

The chemical name of Mirogabalin is (1R,5S,6S)-6-(Aminomethyl)-3-ethylbicyclo[3.2.0]hept-3-ene-6-acetic acid. The chemical formula for Mirogabalin is C₁₂H₁₉NO₂, and its molecular weight is approximately 209.29 g/mol.

Mirogabalin reduces calcium influx and neurotransmission in dorsal root ganglia, as it has binding affinities for human α2δ subunits of voltage-gated calcium channels (VGCCs). It prevents neurotransmitter release in presynaptic nerve endings.

Mirogabalin Impurities and Synthesis

While synthesizing Mirogabalin2, impurities may form that will affect drug safety and efficacy. They form during the synthetic process, storage, or purification of Mirogabalin. Manufacturers can control and monitor Mirogabalin impurities to improve the drug’s safety, efficacy, and storage.
Daicel Pharma offers a comprehensive Certificate of Analysis (CoA) for Mirogabalin impurities, which includes Mirogabalin Enantiomer, Mirogabalin Lactam Impurity, and Racemic Mixture of Mirogabalin (Benzene sulfonic acid salt). The CoA offered to clients is from a cGMP-compliant analytical facility. It has complete characterization data such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity. We give additional spectral data on request. Daicel Pharma can prepare any unidentified Mirogabalin impurity or degradation product. In addition, Daicel Pharma offers highly purified, stable isotope-labeled standards of Mirogabalin. Daicel Pharma provides a complete characterization report accompanying the delivery.