Description

Ranolazine-D3 is a stable isotope-labeled analog of the antianginal pharmaceutical agent ranolazine, specifically deuterated at three positions. This compound is an essential internal standard for the precise and accurate quantification of ranolazine in biological matrices using advanced analytical techniques like LC-MS/MS. It is primarily required by pharmaceutical research and development laboratories, clinical research organizations (CROs), and bioanalytical service providers engaged in pharmacokinetic studies, drug metabolism research, and therapeutic drug monitoring.

Application

• Bioanalytical Internal Standard: Serves as a critical deuterated internal standard for the quantification of ranolazine in plasma, serum, and other biological samples via mass spectrometry.
• Pharmacokinetic (PK) and Pharmacodynamic (PD) Studies: Enables accurate measurement of drug concentration-time profiles to determine absorption, distribution, metabolism, and excretion (ADME) parameters.
• Drug Metabolism and Disposition Research: Used in studies to identify and quantify ranolazine metabolites, aiding in understanding its metabolic pathways.
• Clinical Trial Support: Essential for bioanalysis in clinical trials to ensure reliable data on drug exposure and patient compliance.
• Therapeutic Drug Monitoring (TDM) Method Development: Facilitates the development and validation of robust analytical methods for monitoring ranolazine levels in patients.
• Quality Control in Reference Material Production: Used in the preparation and certification of certified reference materials (CRMs) for ranolazine.

Basic Information

Product Name	Ranolazine-D3
CAS No.	1054624-77-9
Molecular Formula	C24H30D3N3O4
Molecular Weight	431.55 g/mol (approximate)
Synonyms	(±)-N-(2,6-Dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-1-piperazineacetamide-d3; Ranolazine (D3); 1-[3-(2-Methoxyphenoxy)-2-hydroxypropyl]-4-[(2,6-dimethylphenyl)aminocarbonylmethyl]piperazine-d3; RS 43285-d3; CVT 303-d3; CVT-303-d3
EINECS	Contact for details

Quality Control

Our Ranolazine-D3 is manufactured under strict quality control protocols to ensure high chemical purity and isotopic enrichment suitable for sensitive analytical applications. Each batch is analyzed by NMR, HPLC, and MS to confirm identity, chemical purity, and deuterium incorporation. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to minimize exposure to atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 98.0%
Isotopic Purity (Deuterium Incorporation)	≥ 98 atom % D
Chemical Purity (by NMR)	Conforms
Residual Solvents (GC)	Meets ICH guidelines

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