Description

6A€-Carboxy Simvastatin-D6 is a high-purity, deuterium-labeled analog of a key simvastatin metabolite, specifically designed for use as an internal standard in quantitative bioanalytical methods. This compound is critical for ensuring the accuracy and reliability of mass spectrometry-based analyses in pharmacokinetic and metabolic studies. It is an essential tool for pharmaceutical R&D laboratories, contract research organizations (CROs), and regulatory agencies focused on drug development and bioequivalence testing for cholesterol-lowering medications.

Application

• Primary use as an internal standard in LC-MS/MS and GC-MS quantification of simvastatin and its metabolites in biological matrices (plasma, serum, urine).
• Critical for conducting pharmacokinetic (PK) and bioavailability/bioequivalence (BA/BE) studies for generic and novel statin formulations.
• Enables precise metabolite profiling and drug metabolism studies in preclinical and clinical research.
• Supports forensic and anti-doping analysis where accurate quantification of statins is required.
• Used in the development and validation of regulatory-compliant analytical methods following FDA, EMA, and ICH guidelines.
• Facilitates stable isotope dilution analysis to correct for matrix effects and instrument variability, ensuring superior data integrity.

Basic Information

Product Name	6A€-Carboxy Simvastatin-D6
CAS No.	1346604-34-9
Molecular Formula	C25H32D6O6
Molecular Weight	~428.58 g/mol
Synonyms	6'-Carboxy Simvastatin-d6; 6'-Carboxy Simvastatin Deuterated; Simvastatin 6'-Carboxylic Acid-d6; (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 2,2-dimethylbutanoate-3',5',6',7',8',8a'-d6-6'-carboxylic acid; 6'-Hydroxymethyl Simvastatin Hydroxy Acid-d6 (carboxyl form); Deuterated Simvastatin Acid Metabolite; L-654,969-d6 (carboxy form).
EINECS	Contact for details

Quality Control

Our 6A€-Carboxy Simvastatin-D6 is manufactured under strict quality systems to ensure the high chemical and isotopic purity required for sensitive analytical applications. Each batch is characterized by advanced spectroscopic and chromatographic techniques, including NMR, HPLC, and MS, to confirm structure, isotopic enrichment (typically ≥98 atom % D), and chemical purity. A comprehensive Certificate of Analysis (COA) detailing purity, assay, and impurity profile is provided with every shipment, supporting compliance with GMP/GLP principles for research use.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a freezer. This compound is hygroscopic (moisture-sensitive); ensure the container is sealed under inert atmosphere or with desiccant to maintain stability and purity upon repeated use. Allow the sealed vial to equilibrate to room temperature before opening to minimize moisture ingress.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC-MS)	Conforms to structure
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥98.0%
Isotopic Purity (Atom % D)	≥98.0% (by MS)
Water Content (KF)	≤0.5%
Residual Solvents (GC)	Complies with ICH limits

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