Description

Nicorandil Impurity 4 Dinitrate is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient Nicorandil. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in Nicorandil API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurities during drug substance synthesis and quality control.
• Stability Studies: Employed to track the formation of degradation products in Nicorandil formulations under various stress conditions (e.g., heat, humidity, light).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive impurity characterization data required for drug master files (DMFs) and investigational new drug (IND) applications.
• Pharmacopeial Testing: Used to comply with pharmacopeial monographs (e.g., USP, EP, JP) that specify limits for known and unknown impurities.
• Research & Development: Serves as a key intermediate or marker in synthetic chemistry research and the study of Nicorandil's metabolic pathways.

Basic Information

Product Name	Nicorandil Impurity 4 Dinitrate
CAS No.	1798026-96-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	N-[2-(Nitrooxy)ethyl]-3-pyridinecarboxamide dinitrate; Nicorandil Related Compound Dinitrate; Nicorandil Nitrate Impurity; 3-Pyridinecarboxamide, N-[2-(nitrooxy)ethyl]-, dinitrate; Nicorandil Dinitrate Derivative; Nicorandil Process Impurity 4 Dinitrate
EINECS	Contact for details

Quality Control

Every batch of Nicorandil Impurity 4 Dinitrate is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical characterization using advanced techniques such as HPLC, GC-MS, and NMR to ensure identity, purity, and stability. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with in-house specifications. We support compliance with cGMP, ICH Q3A/B, and other relevant regulatory guidelines for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. The material is light-sensitive (store away from light) and may be hygroscopic (moisture-sensitive). Keep the container tightly sealed in a dry and well-ventilated place.

Specification

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

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