Description

Nicorandil Impurity 13 is a specified impurity of the pharmaceutical substance Nicorandil, a vasodilator used in the treatment of angina pectoris. This compound is critical for pharmaceutical manufacturers and analytical laboratories for method development, quality control, and regulatory compliance. It is primarily used by professionals in the pharmaceutical industry for research, development, and the production of high-purity active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of impurities in Nicorandil drug substance and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or GC methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure Nicorandil API and products meet stringent pharmacopeial (e.g., USP, EP, JP) and ICH guidelines for impurity limits.
• Regulatory Compliance & Filing: Critical for preparing regulatory submission documents (e.g., CMC section of IND/NDA) to demonstrate control over the manufacturing process and product quality.
• Stability Studies: Employed to track the formation and levels of this specific impurity under various stress conditions (heat, light, humidity) as per ICH Q1A(R2).
• Process Chemistry Research: Used by R&D chemists to study and optimize synthetic pathways to minimize the formation of this impurity during Nicorandil manufacturing.

Basic Information

Product Name	Nicorandil Impurity 13
CAS No.	19416-51-4
Molecular Formula	C8H9N3O4
Molecular Weight	211.18 g/mol
Synonyms	N-(2-Hydroxyethyl)nicotinamide nitrate; 2-(Nitrooxy)ethyl nicotinate; Nicorandil Related Compound; Nicorandil EP Impurity; Nicorandil USP Impurity; 3-Pyridinecarboxylic acid, 2-[(nitrooxy)ethyl] ester; SG 75 Impurity
EINECS	Contact for details

Quality Control

Every batch of Nicorandil Impurity 13 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our quality system is designed to meet the exacting standards of the pharmaceutical industry. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, residual solvents, and other critical parameters as per client requirements or in-house specifications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 95.0%
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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