Description

Nicorandil Impurity 16 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 and spectroscopic methods. 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.
• Analytical Method Development & Validation: Essential for developing, validating, and transferring HPLC, UPLC, or GC methods to monitor impurities during stability studies and release testing.
• Quality Control & Assurance (QC/QA): Provides a definitive benchmark for impurity profiling to ensure batch-to-batch consistency and compliance with pharmacopeial standards (e.g., USP, EP, ICH Q3A/B).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., DMF, CMC sections) by providing characterized impurity data required for drug approval processes.
• Stability Studies: Employed to track the formation and levels of this specific impurity under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and to develop robust purification processes for Nicorandil.

Basic Information

Product Name	Nicorandil Impurity 16
CAS No.	1157-74-0
Molecular Formula	C8H9N3O4
Molecular Weight	211.18 g/mol
Synonyms	N-(2-Hydroxyethyl)nicotinamide nitrate; 2-(Pyridine-3-carboxamido)ethyl nitrate; 3-Carbamoylethyl nicotinate nitrate; Nicorandil Related Compound; Nicorandil Degradant; Nicorandil Nitrate Ester Impurity
EINECS	Contact for details

Quality Control

Every batch of Nicorandil Impurity 16 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using validated methods (e.g., HPLC, NMR, MS) to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, chromatograms, and traceability information.

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 reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Assay (on dried basis)	97.0% - 103.0%
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.