Description

Rosuvastatin-D3 is a high-purity, stable isotope-labeled analog of the widely prescribed statin medication, Rosuvastatin. This compound is an essential reference standard and internal standard for the accurate quantification and pharmacokinetic profiling of Rosuvastatin in complex biological matrices. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities engaged in drug development, bioequivalence studies, and clinical research.

Application

• LC-MS/MS Internal Standard: Serves as a critical internal standard for the precise and accurate quantification of Rosuvastatin in bioanalytical methods using liquid chromatography-tandem mass spectrometry (LC-MS/MS).
• Pharmacokinetic and Metabolism Studies: Used in ADME (Absorption, Distribution, Metabolism, Excretion) studies to track the fate of Rosuvastatin in biological systems, enabling detailed metabolic pathway analysis.
• Drug Impurity Profiling and Characterization: Acts as a reference material for identifying and quantifying potential deuterated impurities or metabolites in active pharmaceutical ingredient (API) batches.
• Clinical Research and Bioequivalence Testing: Essential for ensuring data integrity in clinical trials and bioequivalence studies for generic Rosuvastatin formulations.
• Stable Isotope Dilution Assays (SIDA): Employed in highly accurate assay techniques that rely on isotope dilution to minimize matrix effects and improve analytical precision.
• Forensic and Doping Control Analysis: Supports analytical methods in forensic toxicology and anti-doping laboratories for the definitive identification of Rosuvastatin.

Basic Information

Product Name	Rosuvastatin-D3
CAS No.	1279031-70-7
Molecular Formula	C22H25D3FN3O6S
Molecular Weight	484.53 g/mol
Synonyms	Rosuvastatin-d3; Deuterated Rosuvastatin; (3R,5S,6E)-7-[4-(4-Fluorophenyl)-2-(N-methylmethanesulfonamido)-6-(propan-2-yl)pyrimidin-5-yl]-3,5-dihydroxyhept-6-enoic Acid-d3; (E)-7-[4-(4-Fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl]-3,5-dihydroxyhept-6-enoic Acid-d3; ZD4522-d3; Crestor-d3
EINECS	Contact for details

Quality Control

Our Rosuvastatin-D3 is manufactured under strict quality control protocols to ensure the highest standards of isotopic purity and chemical integrity, essential for reliable analytical results. Each batch is characterized by advanced spectroscopic and chromatographic techniques, including NMR, HPLC, and mass spectrometry, to confirm identity, isotopic enrichment, and chemical purity. Certificates of Analysis (COA) detailing batch-specific results are provided and can be tailored to meet the requirements of GMP, ICH Q2(R1), and 21 CFR Part 11 compliant environments.

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 desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥98.0%
Isotopic Purity (Deuterium Enrichment)	≥98.0 atom % D
Chemical Purity (NMR)	Conforms
Water Content (KF)	≤1.0%
Residue on Ignition	≤0.1%

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