General Information

Nicorandil Impurities and Nicorandil  

Daicel Pharma offers Nicorandil impurity standards such as 2-Aminoethyl nicotinate HCl and Oxazoalyl pyridine, which play a vital role in assessing the purity, quality, and safety of Nicorandil.  Daicel Pharma provides a custom synthesis of Nicorandil impurities to meet specific client needs, offering global delivery options for convenience.

Nicorandil [CAS: 65141-46-0] is a pyrimidine carboxamide derivative. It exhibits properties similar to nitrates and activates ATP-sensitive potassium channels, thus preventing and treating angina pectoris. Nicorandil functions as both a vasodilator and a potassium channel opener.

Nicorandil: Use and Commercial Availability 

Nicorandil acts as a potassium channel opener and releases nitric oxide (NO). This dual action allows it to dilate both arterial and venous blood vessels. It treats or prevents cardiac arrhythmias. It is available under the tradename of Ikorel.

Nicorandil Structure and Mechanism of Action

The chemical name of Nicorandil is N-[2-(Nitrooxy)ethyl]-3-pyridinecarboxamide. Its chemical formula is C₈H₉N₃O₄, and its molecular weight is approximately 211.18 g/mol.

Nicorandil activates and opens ATP-sensitive potassium channels composed of Kir6.x-type and sulfonylurea receptor subunits.

Nicorandil Impurities and Synthesis

Nicorandil impurities can arise during the manufacturing process¹. They are of concern because they can impact the drug’s quality, effectiveness, and safety. Impurities can affect the drug’s stability and pharmacokinetics and cause harm. Extensive analysis and control of Nicorandil impurities are required to satisfy regulatory criteria and maintain patient safety. It comprises comprehensive impurity characterization and methods to reduce their formation during manufacture and storage.

Daicel Pharma offers a Certificate of Analysis (CoA) from a cGMP-compliant analytical facility for Nicorandil impurity standards which are 2-Aminoethyl nicotinate HCl and Oxazoalyl pyridine. Daicel Pharma offers a cGMP-certified analytical laboratory that provides the CoA, which includes thorough characterization data including 1H NMR, 13C NMR, IR, MASS, and HPLC purity². On request, we give more characterization details, such as those for 13C-DEPT. At Daicel Pharma, our team of experts is technically capable of synthesizing Nicorandil impurities and labeled compounds to evaluate generic Nicorandil.