Nicorandil is a synthetic potassium channel opener and nitrate-containing vasodilator used as a pharmaceutical active pharmaceutical ingredient (API). It combines potassium-channel-opening activity with nitrate-mediated vasodilator effects and is primarily associated with the management of angina pectoris.
Nicorandil is chemically classified as a pyridinecarboxamide nitrate ester. The BP 2025 / Ph. Eur. monograph defines Nicorandil as 2-[(pyridin-3-ylcarbonyl)amino]ethyl nitrate.
Nicorandil is an established cardiovascular pharmaceutical API used in the development and manufacture of anti-anginal formulations.
The current BP 2025 / Ph. Eur. monograph specifies Nicorandil content of 99.0% to 101.0% on the anhydrous substance.
CAS Number: 65141-46-0
Molecular Formula: C₈H₉N₃O₄
Molecular Weight: 211.17 g/mol
Chemical Name: 2-[(Pyridin-3-ylcarbonyl)amino]ethyl nitrate
IUPAC Name: N-[2-(Nitrooxy)ethyl]pyridine-3-carboxamide
Drug Class: Potassium Channel Opener / Vasodilator
Therapeutic Class: Anti-Anginal Agent
Therapeutic Area: Cardiovascular
Molecule Type: Synthetic Small Molecule
PubChem confirms CAS 65141-46-0, molecular formula C₈H₉N₃O₄ and molecular weight 211.17 g/mol.
Nicorandil produces vasodilation through two complementary mechanisms.
Its pharmacological activity includes:
Nicorandil is therefore characterized by both potassium-channel-opening and nitrate-like vasodilator activity.
Nicorandil API is relevant to:
Nicorandil is primarily used as an anti-anginal medicine. Its vasodilator properties help improve coronary blood flow and reduce the workload placed on the heart.
It is particularly associated with long-term management of stable angina pectoris in appropriate clinical settings.
Nicorandil activates ATP-sensitive potassium channels in vascular smooth muscle.
This causes membrane hyperpolarization and contributes to vascular relaxation. The potassium-channel-opening mechanism complements its nitrate-mediated vasodilator effect.
Nicorandil contains a nitrate ester group capable of producing nitrate-like pharmacological effects.
The nitrate component contributes to vascular smooth muscle relaxation through the nitric oxide–cyclic GMP pathway.
The BP 2025 / Ph. Eur. monograph describes Nicorandil as a white or almost white, crystalline powder. It is sparingly soluble in water, freely soluble in anhydrous ethanol and practically insoluble in heptane.
Published laboratory data report a melting point around 91–93°C, with decomposition reported in some sources.
According to the BP 2025 / Ph. Eur. monograph, Nicorandil is:
These pharmacopoeial descriptions should be preferred for the CMS over generic supplier solubility statements.
A controlled Nicorandil API manufacturing process may involve:
Typical Nicorandil API testing may include:
The BP 2025 / Ph. Eur. monograph specifically defines identification by infrared absorption spectrophotometry, pH, related substances, sulfates, water, sulfated ash and assay.
The BP 2025 / Ph. Eur. monograph specifies storage at 2°C to 8°C.
For commercial API handling, the storage condition should always be reconciled with the manufacturer's validated stability data and current approved specification.
Nicorandil is relevant to research involving:
| Parameter | Specification |
|---|---|
| Appearance | White crystalline powder or crystals |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 99.0% – 101.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| pH (1% Solution) | 5.5 – 7.0 |
| Individual Impurity | NMT 0.5% |
| Water Content | NMT 0.5% |