Description

2-Hydroxy Atorvastatin Lactone-D5 is a deuterated analog of a key atorvastatin metabolite, specifically designed for use as an internal standard in quantitative bioanalytical studies. This high-purity reference material is essential for ensuring the accuracy and reliability of mass spectrometry-based assays in pharmaceutical research and development. It is primarily utilized by analytical chemists and researchers in pharmaceutical companies, contract research organizations (CROs), and academic laboratories focused on pharmacokinetics, drug metabolism, and bioequivalence studies for statin therapies.

Application

• Internal Standard for LC-MS/MS: Critical for the precise quantification of atorvastatin and its metabolites in biological matrices (plasma, serum, urine) due to its isotopically labeled structure.
• Pharmaceutical R&D: Supports method development and validation in drug metabolism and pharmacokinetics (DMPK) studies for statin drugs.
• Bioanalytical Assay Calibration: Used to create calibration curves and ensure assay precision and accuracy in clinical and non-clinical trials.
• Metabolite Profiling and Identification: Aids in the identification and study of atorvastatin's metabolic pathways.
• Quality Control in Manufacturing: Can be employed in analytical laboratories to monitor process-related impurities in atorvastatin active pharmaceutical ingredient (API) production.
• Forensic and Doping Analysis: Potential application in specialized testing for pharmaceutical compounds in forensic or anti-doping contexts.

Basic Information

Product Name	2-Hydroxy Atorvastatin Lactone-D5
CAS No.	265989-50-2
Molecular Formula	C33H29D5FN2O5
Molecular Weight	~ 571.65 g/mol
Synonyms	Atorvastatin 2-Hydroxy Lactone-D5; [2H5]-2-Hydroxy Atorvastatin Lactone; (3R,5R)-7-[2-(4-Fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic Acid δ-Lactone-3,5-d2,6,6,7-d3; Deuterated Atorvastatin Lactone Metabolite; Atorvastatin-d5 Lactone Metabolite; 2-Exo-hydroxy Atorvastatin Lactone-D5; Internal Standard for Atorvastatin Analysis-d5
EINECS	Contact for details

Quality Control

Every batch of 2-Hydroxy Atorvastatin Lactone-D5 is manufactured and analyzed under strict quality systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic methods, to ensure compliance with the high-purity standards required for reference materials and internal standards. Certificates of Analysis (COA) are provided, detailing purity, isotopic enrichment, and impurity profiles. We support compliance with cGMP and ICH guidelines for pharmaceutical development.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC-MS)	Conforms
Purity (HPLC)	≥ 98.0%
Isotopic Enrichment (MS)	≥ 98 atom % D
Chemical Purity (NMR)	Conforms
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Meets ICH limits

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