Description

(±)-Ranolazine-D8 2Hcl (Piperazine-D8) CAS NO 1219802-60-4 is a deuterated isotopologue of the antianginal pharmaceutical agent ranolazine, where eight hydrogen atoms are replaced with deuterium. This high-purity stable-labeled compound is essential for use as an internal standard in quantitative bioanalytical methods, ensuring unparalleled accuracy and reliability in pharmacokinetic and metabolic studies. It is a critical material for pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical service providers focused on cardiovascular drug development and regulatory compliance.

Application

• Internal Standard for LC-MS/MS: Primary application as a quantitative internal standard in Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) for the precise measurement of ranolazine in biological matrices like plasma and serum.
• Drug Metabolism and Pharmacokinetics (DMPK): Used in absorption, distribution, metabolism, and excretion (ADME) studies to track the parent drug and metabolites without interference from endogenous compounds.
• Bioanalytical Method Development & Validation: Critical for developing and validating robust, GLP/GCP-compliant analytical methods for clinical trials and preclinical studies.
• Stable Isotope Dilution Assays: Enables highly accurate quantification through isotope dilution techniques, minimizing matrix effects and ion suppression.
• Pharmaceutical Quality Control: Potential use in impurity profiling and method development for drug substance and drug product analysis.
• Metabolite Identification & Profiling: Aids in distinguishing drug-derived metabolites from endogenous substances in complex biological samples.

Basic Information

Item	Detail
Product Name	(±)-Ranolazine-D8 2Hcl (Piperazine-D8)
CAS No.	1219802-60-4
Molecular Formula	C24H25D8N3O4 • 2HCl
Molecular Weight	504.48 g/mol (Free base: 433.58)
Synonyms	Ranolazine-d8 dihydrochloride; (±)-N-(2,6-Dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-1-piperazineacetamide-d8 dihydrochloride; 1-Piperazineacetamide-d8, N-(2,6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-, dihydrochloride; RS-43285-d8; CVT-303-d8; Stable Labeled Ranolazine-d8; Deuterated Ranolazine Internal Standard
EINECS	Contact for details

Quality Control

Our (±)-Ranolazine-D8 2Hcl is manufactured under strict quality systems to ensure the high chemical and isotopic purity required for sensitive analytical applications. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing parameters such as isotopic purity (D-enrichment), chemical purity by HPLC, residual solvent content, and identity confirmation by NMR and MS. We adhere to relevant industry standards for stable-labeled compounds used in regulated bioanalysis.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability. For long-term storage, consider desiccants.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (H-NMR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥98.0% (Area %)
Isotopic Purity (D-enrichment)	≥98 atom % D
Water Content (KF)	≤2.0%
Residual Solvents (GC)	Complies with ICH limits
Assay (by HPLC)	95.0% - 105.0% (on anhydrous basis)

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