Description

Nicorandil Impurity 11 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 known benchmark in chromatographic and spectroscopic analyses. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and regulatory affairs departments involved in the development and manufacturing of Nicorandil-based medications.

Application

• Pharmaceutical Reference Standard: Primary use 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: Crucial for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Ultra-Performance Liquid Chromatography (UPLC) assays.
• Stability Studies: Employed to monitor the formation of degradation products under various stress conditions (e.g., heat, light, humidity) to establish shelf-life and proper storage conditions.
• Regulatory Compliance and Filing: Required for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate comprehensive impurity profiling and control strategies.
• Quality Control Testing: Used in routine batch release testing of Nicorandil API to ensure impurity levels remain within International Council for Harmonisation (ICH) guidelines.
• Process Chemistry Research: Aids in identifying and tracking the source of impurities during the synthesis and purification process development of Nicorandil.

Basic Information

Product Name	Nicorandil Impurity 11
CAS No.	149415-43-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	N-[2-(Nitrooxy)ethyl]-3-pyridinecarboxamide Impurity 11; 2-Nicotinamidoethyl Nitrate Related Compound 11; SG-75 Impurity 11; N-(2-Nitrooxyethyl)nicotinamide Impurity; 3-Carbamoylethyl Nicotinate Nitrate Impurity; Nicorandil Related Substance 11
EINECS	Contact for details

Quality Control

Every batch of Nicorandil Impurity 11 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC and mass spectrometry to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated area. Handle and store in accordance with good laboratory practices.

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 unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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