Description

Ranolazine is a selective late sodium current inhibitor used as an active pharmaceutical ingredient (API) in the treatment of chronic angina pectoris. Its primary value lies in its unique mechanism of action, which reduces cardiac ischemia without significantly affecting heart rate or blood pressure, offering a therapeutic option for patients with inadequate response to other antianginal agents. This high-purity compound is essential for pharmaceutical manufacturers and research institutions engaged in the development and production of cardiovascular medications. Ranolazine CAS NO 142387-99-3 is a critical component for ensuring the efficacy and safety of finished drug products.

Application

• Pharmaceutical API: Primary use as the active ingredient in antianginal drug formulations for chronic angina management.
• Cardiovascular Research: A key reference standard and investigational compound in preclinical and clinical studies of myocardial ischemia and arrhythmias.
• Generic Drug Manufacturing: Sourcing for the production of generic ranolazine tablets following patent expiration in various markets.
• Analytical Standard: Used as a high-purity standard in quality control laboratories for HPLC, LC-MS, and other analytical method development and validation.
• Formulation Development: Employed in R&D for developing new dosage forms, such as extended-release tablets, to optimize pharmacokinetic profiles.
• Contract Manufacturing: Supplied to CDMOs (Contract Development and Manufacturing Organizations) for commercial-scale API integration into final drug products.

Basic Information

Product Name	Ranolazine
CAS No.	142387-99-3
Molecular Formula	C24H33N3O4
Molecular Weight	427.54 g/mol
Synonyms	CVT 303; RS 43285; (±)-N-(2,6-Dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-1-piperazineacetamide; 1-Piperazineacetamide, N-(2,6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-; Ranexa (Brand Name); Ranolazine Hydrochloride (Salt Form); RS-43285-000-00
EINECS	Contact for details

Quality Control

Our Ranolazine is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets high-purity pharmacopeial standards, typically referencing ICH guidelines and customer-specific requirements. Key tests include identification, assay, impurity profiling (including related substances and residual solvents), and physical characterization. A Certificate of Analysis (COA) detailing all test results and methods is provided with every shipment to guarantee traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider the use of desiccants.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Related Substances (HPLC)	Total impurities ≤ 1.0%; Any single impurity ≤ 0.5%
Heavy Metals	≤ 20 ppm

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