Description

Ranolazine Impurity 4 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 anti-anginal pharmaceutical agent, Ranolazine. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in drug development and quality control. The material is supplied with comprehensive analytical data to support method validation and impurity profiling studies.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Ranolazine Impurity 4 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (HPLC, UPLC) for impurity analysis in compliance with ICH guidelines.
• Quality Control & Assurance (QC/QA): Serves as a system suitability and calibration standard in routine quality control testing of Ranolazine batches to ensure they meet pharmacopeial specifications.
• Stability Studies: Employed to monitor the formation of this specific degradation product during forced degradation and long-term stability studies of Ranolazine formulations.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., with FDA, EMA) to support drug approval and marketing applications.
• Research & Development: Used in metabolic and pharmacokinetic studies to understand the impurity's profile and its potential impact.

Basic Information

Product Name	Ranolazine Impurity 4
CAS No.	1427177-23-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ranolazine Related Compound 4; Ranolazine EP Impurity D; Ranolazine USP Impurity; 1-Piperazineacetamide, N-(2,6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-, (2R,3S)-; (2R,3S)-N-(2,6-Dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-1-piperazineacetamide; Ranolazine Process Impurity; Ranolazine Degradant
EINECS	Contact for details

Quality Control

Our Ranolazine Impurity 4 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation by techniques such as IR and MS, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided to support your compliance with ICH Q3A/B and pharmacopeial (USP, EP) guidelines.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C

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