Description

Cerivastatin-D3, Sodium Salt is a high-purity, isotopically labeled internal standard critical for modern quantitative bioanalytical methods. This deuterated compound is essential for ensuring the accuracy, precision, and reliability of mass spectrometry-based analyses in pharmaceutical research and development. It is primarily utilized by analytical chemists and researchers in pharmaceutical companies, contract research organizations (CROs), and academic laboratories for pharmacokinetic studies, drug metabolism investigations, and clinical trial sample analysis.

Application

• Internal Standard for LC-MS/MS: Serves as a critical reference compound for the precise quantification of Cerivastatin and its metabolites in complex biological matrices like plasma, serum, and urine.
• Pharmacokinetic (PK) and Bioequivalence Studies: Enables accurate measurement of drug concentration over time, which is fundamental for determining absorption, distribution, metabolism, and excretion (ADME) profiles.
• Drug Metabolism and Pharmacokinetics (DMPK) Research: Used in vitro and in vivo studies to track and quantify parent drug and metabolite formation, aiding in understanding metabolic pathways.
• Clinical Trial Analysis: Supports the robust and GLP-compliant analysis of patient samples during clinical development phases to ensure data integrity.
• Method Development and Validation: Acts as a key component in developing, optimizing, and validating sensitive and selective bioanalytical assays according to regulatory guidelines (e.g., FDA, EMA).
• Quality Control in Pharmaceutical Manufacturing: Can be employed in impurity profiling and stability-indicating methods for the active pharmaceutical ingredient (API).

Basic Information

Product Name	Cerivastatin-D3, Sodium Salt
CAS No.	916314-45-9
Molecular Formula	C26H30D3FNO5•Na
Molecular Weight	Approx. 490.53 g/mol
Synonyms	Cerivastatin-d3 sodium salt; Sodium (3R,5S,6E)-7-[4-(4-fluorophenyl)-2,6-diisopropyl-5-(methoxymethyl)pyridin-3-yl]-3,5-dihydroxyhept-6-enoate-d3; (E)-7-[4-(4-Fluorophenyl)-5-(methoxymethyl)-2,6-di(propan-2-yl)pyridin-3-yl]-3,5-dihydroxyhept-6-enoic-3,4,5-d3 acid sodium salt; Bayw 6228-d3 sodium salt; Deuterated Cerivastatin Sodium Salt; Cerivastatin Internal Standard-d3.
EINECS	Contact for details

Quality Control

Our Cerivastatin-D3, Sodium Salt is manufactured under strict quality control protocols to ensure the high chemical and isotopic purity required for analytical applications. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing parameters such as assay (by HPLC), isotopic enrichment, and impurity profile. We adhere to relevant industry standards for reference materials to support GLP and GMP-compliant research.

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 compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥98.0% (on anhydrous basis)
Isotopic Purity (deuterium, D)	≥99.0 atom % D
Chemical Purity (HPLC)	≥98.0%
Water Content (KF)	≤2.0%
Residue on Ignition	≤0.5%

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