Description

Desmethyl Ranolazine -D-Glucuronide is a key metabolite and reference standard of the anti-anginal drug Ranolazine. This compound is of critical importance for pharmaceutical research and development, particularly in the areas of drug metabolism and pharmacokinetics (DMPK) studies. It is primarily used by analytical laboratories, contract research organizations (CROs), and pharmaceutical companies for bioanalytical method development, validation, and quantification in biological matrices.

Application

• Pharmaceutical Reference Standard: Serves as a certified standard for the quantitative analysis of Ranolazine and its metabolites in clinical and preclinical studies.
• Drug Metabolism Studies: Essential for investigating the metabolic pathways, clearance mechanisms, and pharmacokinetic profile of Ranolazine.
• Bioanalytical Method Development: Used to develop and validate sensitive HPLC-MS/MS or LC-MS methods for accurate quantification in plasma, serum, or urine.
• Impurity Profiling: Acts as a known impurity or degradation product standard to ensure the purity and stability of Ranolazine drug substance and products.
• Toxicology and Safety Assessment: Employed in studies to understand the safety profile and potential toxicity of Ranolazine metabolites.
• Regulatory Submissions: Provides critical data to support Investigational New Drug (IND) and New Drug Application (NDA) filings with regulatory bodies like the FDA and EMA.

Basic Information

Product Name	Desmethyl Ranolazine -D-Glucuronide
CAS No.	172300-93-5
Molecular Formula	C23H35N3O8
Molecular Weight	481.54 g/mol
Synonyms	N-(2,6-Dimethylphenyl)-2-[4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]piperazin-1-yl]acetamide D-Glucuronide; Desmethyl Ranolazine Glucuronide; Ranolazine Metabolite Glucuronide; CVT-303 Glucuronide; (±)-N-(2,6-Dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-1-piperazineacetamide β-D-Glucopyranosiduronic Acid
EINECS	Contact for details

Quality Control

Our Desmethyl Ranolazine -D-Glucuronide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, LC-MS for identity confirmation, and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided for traceability and regulatory compliance.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). For long-term storage, consider storing desiccated at -20°C. The product is light-sensitive (store away from light).

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC-MS)	Conforms to structure
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Meets ICH guidelines

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