Description

Ranolazine-D8 is a deuterated isotopologue of the antianginal pharmaceutical agent Ranolazine, specifically labeled with eight deuterium atoms. This stable isotope-labeled compound is a critical reference standard and internal standard for the precise quantification and metabolic study of Ranolazine in biological matrices using advanced analytical techniques like LC-MS/MS. It is an essential material for pharmaceutical R&D, clinical research, and forensic toxicology laboratories requiring high specificity and accuracy in their analytical methods.

Application

• Pharmaceutical Reference Standard: Serves as a certified primary standard for the identification, purity assay, and quantification of non-labeled Ranolazine in drug substance and finished product testing.
• Mass Spectrometry Internal Standard: Used as a stable isotope-labeled internal standard (SIL-IS) in Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) bioanalysis to ensure accurate pharmacokinetic and bioequivalence studies.
• Drug Metabolism and Pharmacokinetics (DMPK) Research: Enables the detailed study of Ranolazine's metabolic pathways, absorption, distribution, and excretion profiles in preclinical and clinical research.
• Forensic and Clinical Toxicology: Facilitates the accurate detection and measurement of Ranolazine in human plasma, serum, or urine for therapeutic drug monitoring or forensic investigations.
• Method Development and Validation: Critical for developing, optimizing, and validating robust analytical methods in compliance with regulatory guidelines (e.g., FDA, ICH).
• Isotope Dilution Analysis: Employed in high-precision analytical techniques to correct for sample preparation losses and instrument variability.

Basic Information

Product Name	Ranolazine-D8
CAS No.	1092804-88-0
Molecular Formula	C24H25D8N3O4
Molecular Weight	427.58 g/mol
Synonyms	Ranolazine-d8; (±)-N-(2,6-Dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-1-piperazineacetamide-d8; 1-[3-(2-Methoxyphenoxy)-2-hydroxypropyl]-4-[(2,6-dimethylphenyl)aminocarbonylmethyl]piperazine-d8; CVT 303-d8; RS 43285-d8
EINECS	Contact for details

Quality Control

Our Ranolazine-D8 is manufactured under strict quality control protocols to ensure the highest chemical and isotopic purity required for analytical applications. Each batch is comprehensively characterized using NMR (¹H, ¹³C), High-Resolution Mass Spectrometry (HRMS), and HPLC to confirm identity, chemical purity, and deuterium incorporation. A Certificate of Analysis (COA) detailing batch-specific results for assay, isotopic enrichment, and related substances is provided. Our quality system supports compliance with relevant pharmacopeial standards for reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccant use and inert atmosphere sealing.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HRMS)	Conforms to structure
Purity (HPLC)	≥98.0% (chemical purity)
Isotopic Purity (Deuterium Enrichment)	≥98 atom % D
Water Content (KF)	≤0.5%
Residue on Ignition	≤0.1%

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