Description

Nifekalant Impurity 11 CAS NO 901571-19-5 is a specified impurity reference standard used in the analytical profiling and quality control of the antiarrhythmic drug Nifekalant. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure product purity, safety, and regulatory compliance. It serves as an essential tool for method development, validation, and routine batch testing in the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Nifekalant Impurity 11 in active pharmaceutical ingredient (API) and finished drug product analysis.
• Analytical Method Development & Validation: A critical component for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurities during stability studies.
• Quality Control & Batch Release: Used in quality control laboratories to establish impurity limits, perform system suitability tests, and ensure batches of Nifekalant meet pharmacopeial (e.g., USP, EP, JP) and ICH Q3A/B guidelines.
• Regulatory Compliance & Filing: Essential for preparing regulatory submission documents (e.g., CMC sections for FDA, EMA) by providing definitive characterization and control of process-related impurities.
• Stability Studies: Employed to track the formation and level of this specific impurity under various stress conditions (e.g., heat, light, humidity) as part of forced degradation and long-term stability testing.
• Research & Development: Used in R&D to study the degradation pathways of Nifekalant and to synthesize purer batches of the API by understanding and controlling impurity formation.

Basic Information

Product Name	Nifekalant Impurity 11
CAS No.	901571-19-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Nifekalant Related Compound 11; Nifekalant EP Impurity J; Nifekalant USP Impurity; Nifekalant Degradation Product; 6-[2-(Dimethylamino)ethyl]-N-(4-fluorophenyl)-2(1H)-quinolinone Impurity; MS-551 Impurity 11; SSR149744C Impurity
EINECS	Contact for details

Quality Control

Every batch of Nifekalant Impurity 11 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic (HPLC, LC-MS) and spectroscopic (NMR, IR) techniques to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing batch-specific results.

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 nature, the material should be handled in a low-humidity environment and the container kept sealed to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.