Description

Ranolazine is a selective late sodium current inhibitor, recognized for its specific pharmacological activity. This high-purity active pharmaceutical ingredient (API) is critical for the development and manufacturing of anti-anginal medications. It is primarily required by pharmaceutical companies and research institutions engaged in cardiovascular drug development and production.

Application

• Pharmaceutical API: Core active ingredient in the manufacture of prescription medications for chronic angina pectoris.
• Cardiovascular Research: Used in preclinical and clinical studies to investigate mechanisms of action and therapeutic efficacy for heart conditions.
• Formulation Development: Serves as a reference standard and key component in developing various dosage forms such as extended-release tablets.
• Generic Drug Manufacturing: Essential for producing bioequivalent generic versions of branded ranolazine products.
• Analytical Standard: High-purity material used for quality control testing, method validation, and calibration in analytical laboratories.

Basic Information

Product Name	Ranolazine
CAS No.	122312-55-4
Molecular Formula	C24H33N3O4
Molecular Weight	427.54 g/mol
Synonyms	CVT 303; (±)-Ranolazine; RS 43285; N-(2,6-Dimethylphenyl)-2-[4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]piperazin-1-yl]acetamide; 1-[3-(2-methoxyphenoxy)-2-hydroxypropyl]-4-[(2,6-dimethylphenyl)aminocarbonylmethyl]piperazine; Ranexa (Trade Name); 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 stringent specifications for pharmaceutical use, including identity, purity, and impurity profiles. Certificates of Analysis (COA) documenting compliance with relevant pharmacopeial standards (e.g., USP) are provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to maintain stability and potency.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 1.5%

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