Description

Nicorandil Impurity 30 is a designated impurity standard used in the analytical profiling and quality control of the pharmaceutical substance Nicorandil. This high-purity reference material 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 tool for pharmaceutical R&D laboratories, quality control (QC) units, and contract research organizations (CROs) involved in method development, validation, and stability studies.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the qualitative and quantitative analysis of Nicorandil active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Serves as a critical component in developing and validating chromatographic methods to separate, identify, and quantify Nicorandil Impurity 30.
• Quality Control & Batch Release Testing: Used in routine QC testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines, ensuring batch-to-batch consistency and compliance.
• Stability Studies & Forced Degradation: Employed to identify and track the formation of this impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and other global health authority requirements.
• Pharmacopoeial Testing: Supports testing in alignment with pharmacopoeial monographs (e.g., USP, EP, JP) that specify impurity limits for Nicorandil.

Basic Information

Product Name	Nicorandil Impurity 30
CAS No.	2365472-37-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Nicorandil Related Compound 30; Nicorandil Specified Impurity 30; N-[2-(Nitrooxy)ethyl]nicotinamide Impurity 30; 2-Nicotinamidoethyl Nitrate Impurity 30; SG-75 Impurity 30; (S)-N-[2-(Nitrooxy)ethyl]nicotinamide Impurity; Potential IUPAC Name: Contact for details
EINECS	Contact for details

Quality Control

Every batch of Nicorandil Impurity 30 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques such as HPLC, GC, NMR, and MS to ensure compliance with high-purity reference standard requirements. 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 in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Assay	≥ 98.0% (on dried basis)
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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