Description

Nicorandil Impurity 26 is a designated impurity 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, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification of this specific impurity. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and contract research organizations (CROs) involved in method development, validation, and stability studies.

Application

• Primary use as a certified reference standard for the identification and quantification of Impurity 26 in Nicorandil Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Critical component in analytical method development and validation (HPLC, UPLC, GC) to meet ICH Q2(R1) and pharmacopeial guidelines.
• Essential for conducting stability studies and forced degradation studies to monitor impurity profiles over the drug's shelf-life.
• Used in pharmaceutical quality control laboratories to ensure batch-to-batch consistency and compliance with strict regulatory limits for impurities.
• Serves as a research tool in pharmacokinetic and metabolic studies to understand the impurity's formation and behavior.
• Supports regulatory submissions (e.g., ANDA, NDA) by providing definitive impurity characterization data required by agencies like the FDA and EMA.

Basic Information

Product Name	Nicorandil Impurity 26
CAS No.	20830-49-3
Molecular Formula	C8H9N3O4
Molecular Weight	211.18 g/mol
Synonyms	N-(2-Hydroxyethyl)nicotinamide nitrate; 2-[(Pyridine-3-carbonyl)amino]ethyl nitrate; SG-75 Impurity; Nicorandil Related Compound; 3-Carbamoylethyl nicotinate nitrate; N-(2-Nitrooxyethyl)nicotinamide
EINECS	Contact for details

Quality Control

Every batch of Nicorandil Impurity 26 is manufactured and analyzed under strict quality systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, GC) and spectroscopic (NMR, MS, IR) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, including assay purity, related substances, residual solvents, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The compound is light-sensitive and should be handled under appropriate conditions to maintain stability and purity.

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%
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.