Description

Ranolazine Impurity 7 is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the anti-anginal drug Ranolazine by accurately identifying and quantifying process-related impurities. It is an essential material for analytical chemists and quality assurance professionals working in pharmaceutical R&D, API production, and regulatory affairs to meet stringent pharmacopeial standards.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Ranolazine Active Pharmaceutical Ingredient (API).
• Critical component in analytical method development and validation (HPLC, UPLC, GC) for impurity profiling.
• Essential for quality control and batch release testing in pharmaceutical manufacturing to ensure compliance with ICH Q3A/B guidelines.
• Used in stability studies to monitor impurity formation and degradation pathways of Ranolazine formulations.
• Serves as a key impurity marker in regulatory submissions (e.g., for FDA, EMA) to demonstrate control of the manufacturing process.
• Valuable for academic and contract research organizations (CROs) conducting pharmaceutical research on cardiovascular drugs.

Basic Information

Product Name	Ranolazine Impurity 7
CAS No.	25772-81-0
Molecular Formula	C24H33N3O4
Molecular Weight	427.54 g/mol
Synonyms	N-(2,6-Dimethylphenyl)-2-[4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]piperazin-1-yl]acetamide; Ranolazine Related Compound 7; Ranolazine EP Impurity G; Ranolazine USP Impurity; 1-Piperazineacetamide, N-(2,6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-; UNII-5Q2B4S7T7F
EINECS	Contact for details

Quality Control

Every batch of Ranolazine Impurity 7 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced chromatographic (HPLC, GC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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