Description

6-Carboxy -5',4',5,6-Simvastatin-D6 CAS NO 1346600-14-3 is a high-purity, deuterium-labeled analog of the carboxylic acid metabolite of Simvastatin, a well-known HMG-CoA reductase inhibitor. This compound is specifically designed for use as an internal standard in quantitative bioanalytical methods, ensuring unparalleled accuracy and reliability in pharmacokinetic and metabolic studies. It is an essential tool for pharmaceutical R&D, contract research organizations (CROs), and analytical laboratories focused on drug development and regulatory compliance.

Application

• Internal Standard for LC-MS/MS Analysis: Primary application as a stable, isotopically labeled reference compound for the precise quantification of Simvastatin and its metabolites in biological matrices like plasma, serum, and urine.
• Pharmacokinetic (PK) and Bioequivalence Studies: Critical for generating reliable data on drug absorption, distribution, metabolism, and excretion (ADME) to support regulatory filings.
• Metabolite Profiling and Identification: Aids in the structural elucidation and quantification of Simvastatin's metabolic pathway products.
• Method Development and Validation: Used to establish, optimize, and validate robust analytical methods in compliance with FDA, EMA, and ICH guidelines.
• Clinical Research: Supports therapeutic drug monitoring and clinical trial sample analysis to ensure data integrity.
• Quality Control in Pharmaceutical Manufacturing: Can be utilized in impurity profiling and stability testing of drug substances and products.

Basic Information

Item	Details
Product Name	6-Carboxy -5',4',5,6-Simvastatin-D6
CAS No.	1346600-14-3
Molecular Formula	C25H30D6O6
Molecular Weight	~ 438.59 g/mol
Synonyms	Simvastatin-6-carboxylic acid-D6; 6-Carboxy Simvastatin-D6; 3,5-Dihydroxy-7-[(1S,2S,6S,8S,8aR)-8-[(2S)-2-(deuteriomethyl)-4-oxo-4-[(2R,4R)-tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl]butyl]-2,6-dimethyl-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]heptanoic acid; 6-β-Hydroxysimvastatin acid-D6; L-654,969 carboxylic acid-D6; Simvastatin hydroxy acid-D6; (3R,5R)-7-[(1S,2S,6S,8S,8aR)-8-[(2S)-2-(Methyl-d3)-4-oxo-4-[(2R,4R)-tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl]butyl]-2,6-dimethyl-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]-3,5-dihydroxyheptanoic acid-d3
EINECS	Contact for details

Quality Control

Our 6-Carboxy -5',4',5,6-Simvastatin-D6 is manufactured under strict quality control protocols to ensure the high chemical and isotopic purity required for sensitive analytical applications. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing results for identity, purity (by HPLC), isotopic enrichment, and other critical parameters. We adhere to relevant industry standards to support GLP/GMP-compliant research.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a freezer. This product is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability. Allow the vial to equilibrate to room temperature before opening to minimize moisture condensation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-enrichment)	≥ 98.0 atom % D
Chemical Purity	≥ 95.0%
Water Content (KF)	≤ 1.0%
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.