Description

Ranolazine Impurity 8 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 utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, stability studies, and impurity profiling. The availability of this well-characterized impurity standard is essential for maintaining stringent quality control in drug substance and drug product manufacturing.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material to identify and quantify Ranolazine Impurity 8 in active pharmaceutical ingredients (APIs) and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for Ranolazine analysis.
• Stability Studies and Forced Degradation: Employed to monitor the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Quality Control and Batch Release Testing: Essential for routine QC testing in pharmaceutical manufacturing to ensure impurity levels are within specified limits.
• Regulatory Submissions and Compliance: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Research and Development: Used in pharmacokinetic and metabolic studies to understand the degradation pathways of Ranolazine.

Basic Information

Product Name	Ranolazine Impurity 8
CAS No.	1213269-66-9
Molecular Formula	C24H33N3O4
Molecular Weight	427.54 g/mol
Synonyms	Ranolazine Related Compound 8; N-(2,6-Dimethylphenyl)-2-[4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]piperazin-1-yl]acetamide; UNII-9W6H8VH2QN; 1-Piperazineacetamide, N-(2,6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-; Ranolazine EP Impurity H; Ranolazine USP Impurity H
EINECS	Contact for details

Quality Control

Every batch of Ranolazine Impurity 8 CAS NO 1213269-66-9 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure identity, purity, and consistency, aligning with current pharmacopeial standards (USP/EP) and ICH guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from advanced analytical techniques including HPLC, GC, MS, and NMR. Our commitment to traceability and documentation supports regulatory compliance for our global clientele.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The material is hygroscopic (moisture-sensitive); ensure the container is kept in a dry environment. For long-term storage, consider storing under an inert atmosphere to prevent oxidation.

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)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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