Description

Nicorandil Impurity 17 is a designated reference standard used in the analytical profiling and quality control of the pharmaceutical substance Nicorandil. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and quality assurance processes.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Nicorandil Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Method Development and Validation: Essential for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and LC-MS.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity levels and ensure compliance with pharmacopeial specifications (e.g., ICH Q3A/B guidelines).
• Stability Studies: Used to track the formation of this specific impurity over time under various stress conditions, supporting drug shelf-life determination.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control.
• Research and Development: Aids in the study of degradation pathways and the synthesis of Nicorandil, supporting process chemistry improvements.

Basic Information

Product Name	Nicorandil Impurity 17
CAS No.	207571-58-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	N-[2-(Nitrooxy)ethyl]-3-pyridinecarboxamide Impurity 17; Nicorandil Related Compound 17; 2-Nicotinamidoethyl Nitrate Impurity 17; SG-75 Impurity; 3-Pyridinecarboxamide, N-[2-(nitrooxy)ethyl]-, impurity; K-725 Impurity; N-(2-Nitrooxyethyl)nicotinamide Impurity
EINECS	Contact for details

Quality Control

Every batch of Nicorandil Impurity 17 is manufactured and handled under strict quality management systems. The product undergoes rigorous analytical testing, including chromatographic purity and identity confirmation, to ensure it meets the high standards required for use as a pharmaceutical reference material. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting compliance with ICH and cGMP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing desiccated at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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