Description

Ranolazine CAS NO 95635-55-5 is a piperazine derivative and a late sodium current inhibitor used as an active pharmaceutical ingredient (API). This compound is critical for the development and manufacturing of anti-anginal medications, offering a unique mechanism of action for managing chronic angina pectoris. It is primarily required by pharmaceutical manufacturers, research institutions, and contract development and manufacturing organizations (CDMOs) involved in cardiovascular drug production.

Application

• Primary use as the Active Pharmaceutical Ingredient (API) in anti-anginal prescription medications.
• Formulation into various solid oral dosage forms, such as extended-release tablets.
• Use in pharmaceutical research and development for studying cardiac electrophysiology.
• Preclinical and clinical trial material for new drug applications (NDAs) and ANDAs.
• Reference standard for analytical method development and quality control in pharmaceutical labs.
• Potential investigational use in other cardiac-related conditions.

Basic Information

Product Name	Ranolazine
CAS No.	95635-55-5
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; Ranexa (Trade Name); 1-Piperazineacetamide, N-(2,6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-; Ranolazine Hydrochloride (Salt form precursor); SR 33589
EINECS	Contact for details

Quality Control

Our ranolazine API is produced under a robust quality management system and is typically supplied to meet high-purity standards suitable for pharmaceutical use. Quality is assured through comprehensive analytical testing, including identification, assay, impurity profiling, and residual solvent analysis. Certificates of Analysis (COA) documenting compliance with agreed specifications are provided with each batch. We can support development of material meeting various pharmacopeial guidelines (e.g., USP monographs).

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated place at controlled room temperature (typically 15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed after opening to prevent degradation from atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms
Assay (HPLC)	98.0% - 102.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.