Description

Nicorandil n-Oxide is a key pharmaceutical intermediate and reference standard in the development and quality control of cardiovascular drugs. Its primary importance lies in its role as a major metabolite and potential impurity of Nicorandil, a widely used antianginal medication. This compound is essential for researchers and manufacturers in the pharmaceutical industry who require high-purity materials for analytical method development, stability studies, and regulatory compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Nicorandil n-Oxide in active pharmaceutical ingredient (API) and finished drug product analysis.
• Metabolite Studies: Critical for pharmacokinetic and metabolic pathway research of Nicorandil, aiding in understanding drug action and safety profiles.
• Impurity Profiling: Serves as a specified impurity standard in the quality control of Nicorandil bulk drug substance, ensuring compliance with pharmacopoeial limits (e.g., EP, USP).
• Analytical Method Development: Employed in validating HPLC, LC-MS, and other chromatographic methods for specificity, accuracy, and linearity.
• Stability Indicating Method: Used to monitor the degradation of Nicorandil under various stress conditions as part of stability studies.
• Process Chemistry Research: Acts as an intermediate or marker in the synthesis and process optimization for Nicorandil production.

Basic Information

Product Name	Nicorandil n-Oxide
CAS No.	107833-98-7
Molecular Formula	C8H9N3O5
Molecular Weight	227.18 g/mol
Synonyms	N-(2-Hydroxyethyl)nicotinamide nitrate oxide; 2-Nicotinamidoethyl nitrate N-oxide; SG-75 metabolite; Nicorandil N-Oxide Impurity; Nicorandil EP Impurity C; Nicorandil Related Compound C; NCO
EINECS	Contact for details

Quality Control

Our Nicorandil n-Oxide is produced and tested under strict quality management systems. Each batch is characterized and controlled to meet the stringent requirements for pharmaceutical reference standards and advanced intermediates. We provide comprehensive analytical data including HPLC purity, identity confirmation (IR, NMR, MS), and related substance profiles. A detailed Certificate of Analysis (COA) is supplied with every shipment, ensuring traceability and compliance with cGMP guidelines where applicable.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry, well-ventilated area. The compound is light-sensitive (store away from light).

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.