Description

Nicorandil Impurity 5 is a designated reference standard used in the analytical profiling and quality control of the pharmaceutical substance Nicorandil. This high-purity compound is critical for ensuring the safety and efficacy of the final drug product by enabling the accurate identification and quantification of process-related impurities. It is an essential material for pharmaceutical R&D laboratories, quality assurance/control (QA/QC) departments, and regulatory compliance teams involved in method development, validation, and stability studies.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for analytical method development and validation (HPLC, GC, LC-MS).
• Quality Control & Assurance: Critical for establishing and monitoring impurity profiles in Nicorandil Active Pharmaceutical Ingredient (API) batches to ensure compliance with ICH guidelines.
• Regulatory Submission & Compliance: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive characterization data for specified impurities.
• Stability Studies: Used to track the formation and levels of this specific impurity under various stress conditions (heat, light, humidity) over time.
• Pharmacopoeial Testing: Employed in testing to meet the specifications of pharmacopoeias such as USP, EP, or JP where Nicorandil impurity profiles are defined.
• Process Chemistry & Optimization: Aids chemists in identifying the source of the impurity during API synthesis, enabling process refinement to minimize its formation.

Basic Information

Product Name	Nicorandil Impurity 5
CAS No.	896133-95-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Nicorandil Related Compound 5; Nicorandil EP Impurity 5; Nicorandil USP Impurity 5; N-(2-Hydroxyethyl)nicotinamide nitrate ester impurity; 2-Nicotinamidoethyl nitrate impurity; 896133-95-2; UNII-Contact for details
EINECS	Contact for details

Quality Control

Our Nicorandil Impurity 5 is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical impurity analysis. Each batch is characterized and tested using advanced analytical techniques, including HPLC and mass spectrometry, to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided with every shipment, detailing batch-specific results and confirming compliance with relevant standards. Our quality commitment supports your needs for regulatory filings and GMP-aligned workflows.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccant use and inert atmosphere to preserve stability.

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)	Single major peak
Water Content (KF)	≤ 5.0%

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