Description

Simvastatin D3 is a high-purity, deuterium-labeled internal standard critical for ensuring the accuracy and reliability of quantitative bioanalytical methods. This stable isotope-labeled compound is indispensable for researchers and quality control laboratories requiring precise measurement of simvastatin and its metabolites in complex biological matrices. It is primarily utilized in pharmaceutical R&D, clinical research, and forensic toxicology for applications such as pharmacokinetic studies and therapeutic drug monitoring.

Application

• Internal Standard for LC-MS/MS: Used as a quantitative internal standard in liquid chromatography-tandem mass spectrometry (LC-MS/MS) assays for simvastatin.
• Pharmacokinetic & Bioavailability Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical research.
• Therapeutic Drug Monitoring (TDM): Supports the development and validation of robust assays to monitor drug levels in patient plasma or serum.
• Metabolite Profiling: Aids in the identification and quantification of simvastatin metabolites in biological samples.
• Method Development & Validation: Serves as a key component in developing and validating GLP/GCP-compliant analytical methods.
• Forensic & Doping Analysis: Provides a reliable reference for detecting and quantifying simvastatin in forensic and anti-doping control.

Basic Information

Product Name	Simvastatin D3
CAS No.	1261364-93-5
Molecular Formula	C₂₅H₃₅D₃O₅
Molecular Weight	421.60 g/mol
Synonyms	Simvastatin-d3; [²H₃]-Simvastatin; Deuterated Simvastatin; (1S,3R,7S,8S,8aR)-8-[2-[(2R,4R)-4-Hydroxy-6-oxotetrahydro-2H-pyran-2-yl]ethyl]-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl (2S)-2,2-dimethylbutanoate-d3; MK 733-d3; Zocor-d3; Lodales-d3; Lipex-d3
EINECS	Contact for details

Quality Control

Our Simvastatin D3 is manufactured under strict quality systems to ensure exceptional isotopic purity and chemical integrity. Each batch is characterized using advanced analytical techniques including NMR, HPLC, and mass spectrometry. A comprehensive Certificate of Analysis (COA) detailing isotopic enrichment, chemical purity, and analytical results is provided with every shipment to support your regulatory and research requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dry, cool place. This product is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (MS)	≥ 99.0 atom % D
Chemical Purity	≥ 95.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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