Description

Fluvastatin-D8 (Major), Sodium Salt is a high-purity, deuterated internal standard of the cholesterol-lowering drug fluvastatin, specifically designed for advanced analytical applications. This compound is essential for ensuring the accuracy and reliability of quantitative bioanalytical methods, such as LC-MS/MS, by correcting for matrix effects and instrument variability. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and regulatory testing facilities engaged in pharmacokinetic studies, drug metabolism research, and quality control of pharmaceutical formulations.

Application

• Quantitative Bioanalysis (LC-MS/MS): Serves as a critical internal standard for the precise and accurate quantification of fluvastatin in biological matrices (plasma, serum, tissue) during pharmacokinetic (PK) and pharmacodynamic (PD) studies.
• Drug Metabolism and Pharmacokinetics (DMPK): Used in mass spectrometry-based assays to study the absorption, distribution, metabolism, and excretion (ADME) profile of fluvastatin in preclinical and clinical research.
• Pharmaceutical Quality Control: Enables accurate assay and impurity profiling of fluvastatin active pharmaceutical ingredient (API) and finished dosage forms, ensuring compliance with pharmacopeial standards.
• Clinical Research & Therapeutic Drug Monitoring (TDM): Facilitates the measurement of fluvastatin concentrations in patient samples to optimize dosing regimens and evaluate therapeutic efficacy.
• Forensic and Anti-Doping Analysis: Employed in confirmatory testing protocols for the detection and quantification of fluvastatin in relevant forensic or sports doping control samples.
• Method Development and Validation: A key reagent for developing, optimizing, and validating robust analytical methods in compliance with ICH, FDA, and EMA guidelines.

Basic Information

Product Name	Fluvastatin-D8 (Major), Sodium Salt
CAS No.	1260178-87-7
Molecular Formula	C24H18D8FNO4•Na
Molecular Weight	433.46 g/mol (approx.)
Synonyms	Fluvastatin-d8 Sodium Salt; (3R,5S,6E)-7-[3-(4-Fluorophenyl)-1-(1-methylethyl)-1H-indol-2-yl]-3,5-dihydroxy-6-heptenoic Acid-d8 Sodium Salt; Lescol-d8 Sodium Salt; XU-62-320-d8 Sodium Salt; (±)-(3R*,5S*,6E)-7-[3-(p-Fluorophenyl)-1-isopropylindol-2-yl]-3,5-dihydroxy-6-heptenoic Acid-d8 Sodium Salt; Fluvastatin (D8 Major) Sodium Salt; Internal Standard for Fluvastatin-d8
EINECS	Contact for details

Quality Control

Every batch of Fluvastatin-D8 (Major), Sodium Salt is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards for deuterated internal standards, including comprehensive identity confirmation, purity assessment, and isotopic enrichment verification. Certificates of Analysis (COA) detailing batch-specific results for assay, isotopic purity, and related substances are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dry environment. This product is hygroscopic (moisture-sensitive). Allow the sealed vial to equilibrate to room temperature before opening to minimize moisture uptake.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D8)	≥ 98.0 atom % D
Chemical Purity (NMR)	Conforms
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Meets ICH guidelines

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