Description

2-Hydroxy Atorvastatin-D5 Disodium Salt is a high-purity, isotopically labeled internal standard critical for advanced analytical quantification. This deuterated compound is essential for ensuring the accuracy and reliability of mass spectrometry-based assays by correcting for variations in sample preparation and instrument response. It is primarily required by pharmaceutical R&D laboratories, bioanalytical contract research organizations (CROs), and quality control departments for the precise pharmacokinetic study, metabolic profiling, and impurity analysis of atorvastatin and its related substances.

Application

• Bioanalytical Method Development & Validation: Serves as a stable isotope-labeled internal standard (SIL-IS) for the accurate quantification of atorvastatin and its 2-hydroxy metabolite in complex biological matrices (e.g., plasma, serum) using LC-MS/MS.
• Pharmacokinetic (PK) and Toxicokinetic (TK) Studies: Enables precise measurement of drug concentration-time profiles, essential for determining bioavailability, half-life, and clearance rates in clinical and non-clinical research.
• Metabolite Identification and Profiling: Used as a reference standard in mass spectrometry to identify and quantify specific oxidative metabolites of atorvastatin, aiding in drug metabolism and safety studies.
• Impurity Testing and Control: Acts as a critical reference material for the identification and quantification of process-related impurities and degradation products in active pharmaceutical ingredient (API) and finished drug product quality control.
• Doping Control Analysis: Employed in forensic and sports anti-doping laboratories for the sensitive and confirmatory detection of statin misuse.
• Regulatory Submissions: Provides essential data traceability and method robustness required for filings with regulatory bodies like the FDA and EMA.

Basic Information

Product Name	2-Hydroxy Atorvastatin-D5 Disodium Salt
CAS No.	1276537-19-9
Molecular Formula	C33H29D5FN2Na2O5
Molecular Weight	Contact for details
Synonyms	Atorvastatin 2-Hydroxy-D5 Disodium Salt; (3R,5R)-7-[2-(4-Fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-(propan-2-yl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic-3,5,5,6,6-D5 Acid 2-Hydroxy Derivative Disodium Salt; 2-OH Atorvastatin-d5 Disodium Salt; Deuterated 2-Hydroxy Atorvastatin Disodium Salt; Atorvastatin 2-Hydroxy Metabolite-d5 Disodium Salt; 2-Hydroxyatorvastatin-D5 Disodium Salt; Internal Standard for Atorvastatin 2-OH Metabolite
EINECS	Contact for details

Quality Control

Every batch of 2-Hydroxy Atorvastatin-D5 Disodium Salt is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assessment, and isotopic enrichment verification using advanced techniques including NMR, HPLC, and high-resolution mass spectrometry. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for chemical purity, isotopic purity (D-enrichment), and residual solvent analysis, ensuring full traceability and compliance with research-grade standards.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a freezer. Due to its hygroscopic (moisture-sensitive) nature, the container should be allowed to equilibrate to room temperature before opening to prevent condensation. For long-term storage, consider desiccant in the storage environment.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-enrichment)	≥ 98.0 atom % D
Chemical Purity (by NMR)	Conforms
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Meets ICH guidelines

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