Description

Nicorandil Impurity 2 is a designated impurity 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 reference marker in chromatographic analyses. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, method development, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Nicorandil Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or GC methods to monitor impurity profiles.
• Quality Control & Batch Release: Employed in routine QC testing to ensure Nicorandil batches meet pharmacopeial specifications (e.g., ICH Q3A/B, USP, EP) for impurity limits.
• Stability Studies: Used to track the formation of this specific impurity under various stress conditions (heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies.
• Research & Synthesis Monitoring: Aids chemists in monitoring the synthesis pathway of Nicorandil, helping to optimize processes to minimize impurity formation.

Basic Information

Product Name	Nicorandil Impurity 2
CAS No.	88598-33-8
Molecular Formula	C8H9N3O4
Molecular Weight	211.18 g/mol
Synonyms	N-(2-Hydroxyethyl)nicotinamide nitrate; 2-[(Nitrooxy)ethyl]-3-pyridinecarboxamide; Nicorandil Related Compound; Nicorandil EP Impurity B; Nicorandil USP Impurity; SG-75 Impurity; 3-Carbamoylpyridin-1-ium-1-ylethyl nitrate
EINECS	Contact for details

Quality Control

Every batch of Nicorandil Impurity 2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA), detailing batch-specific results, is provided with each shipment to support your regulatory and quality assurance requirements.

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 under inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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