Description

Nicorandil Impurity 27 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 analyses. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and quality assurance processes.

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.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating stability-indicating HPLC or UPLC methods to monitor impurity profiles.
• Quality Control & Batch Release: Used in routine QC testing to ensure Nicorandil batches comply with stringent pharmacopeial (e.g., USP, EP, JP) and ICH Q3A/B guidelines for impurities.
• Stability Studies: Employed to track the formation and growth of this specific impurity during forced degradation and long-term stability studies of Nicorandil.
• Regulatory Submissions: Critical for preparing regulatory documentation (e.g., CMC sections for FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Supports synthetic route optimization and process chemistry studies to understand and minimize the formation of this impurity.

Basic Information

Product Name	Nicorandil Impurity 27
CAS No.	872299-21-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	N-[2-(Nitrooxy)ethyl]-3-pyridinecarboxamide Impurity 27; 2-Nicotinamidoethyl Nitrate Related Compound 27; Nicorandil Related Substance 27; Nicorandil EP Impurity G (Confirm with supplier); Potential IUPAC name variant; (Consult COA for definitive identification)
EINECS	Contact for details

Quality Control

Every batch of Nicorandil Impurity 27 is manufactured and handled under strict quality management systems. The product undergoes rigorous identity confirmation and purity analysis using advanced techniques such as HPLC, GC, NMR, and MS to ensure it meets 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 (typically 15-25°C) or as specified on the Certificate of Analysis. The material should be kept in a dry environment to prevent moisture uptake. For long-term storage, consider conditions recommended for high-purity organic standards.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (NMR/IR)	Conforms to structure
Purity (HPLC)	≥ 95.0% (Area Percent)
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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