Description

Nicorandil Impurity 18 (Nicorandil Dimer Bromide) is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of Nicorandil, a pharmaceutical agent used in the treatment of angina pectoris. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The availability of this well-characterized impurity is essential for maintaining strict compliance with global pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Nicorandil Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor and control the level of this specific dimer impurity.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure Nicorandil products meet stringent purity specifications as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Used to track the formation of degradation products in Nicorandil formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Serves as a key reagent in studies investigating the synthesis pathways, degradation mechanisms, and pharmacokinetics of Nicorandil.

Basic Information

Product Name	Nicorandil Impurity 18 (Nicorandil Dimer Bromide)
CAS No.	2250142-73-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Nicorandil Dimer Bromide; Nicorandil Brominated Dimer; N-(2-Hydroxyethyl)nicotinamide nitrate dimer bromide derivative; Impurity 18 of Nicorandil; Nicorandil Related Compound 18; 2-Nicotinamidoethyl nitrate dimer bromide; SG-75 impurity 18
EINECS	Contact for details

Quality Control

Every batch of Nicorandil Impurity 18 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided and is available upon request to support your regulatory and quality needs.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 2.0%

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