Description

Para-Hydroxy Atorvastatin-D5 Calcium Salt is a high-purity, isotopically labeled internal standard critical for advanced analytical chemistry. This compound is essential for ensuring the accuracy and reliability of quantitative bioanalytical methods, particularly in pharmacokinetic and metabolic studies. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and regulatory testing facilities that require definitive analytical data.

Application

• Quantitative Bioanalysis: Serves as a stable isotope-labeled internal standard for the precise quantification of atorvastatin and its metabolites in biological matrices (e.g., plasma, serum) using LC-MS/MS.
• Pharmacokinetic/Pharmacodynamic (PK/PD) Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) in clinical and pre-clinical research.
• Drug Metabolism Studies: Used to investigate metabolic pathways and identify specific hydroxy-metabolites of atorvastatin.
• Method Development and Validation: A key reagent for developing, optimizing, and validating robust, GLP-compliant analytical methods.
• Quality Control in Manufacturing: Supports impurity profiling and assay verification during the production of active pharmaceutical ingredients (APIs).
• Reference Standard: Acts as a certified reference material for calibrating instruments and ensuring analytical method accuracy.

Basic Information

Product Name	Para-Hydroxy Atorvastatin-D5 Calcium Salt
CAS No.	265989-45-5
Molecular Formula	C66H68D5CaF2N4O10 • xH2O
Molecular Weight	Contact for details
Synonyms	Atorvastatin-d5 Hydroxy Metabolite Calcium Salt; [R-(R*,R*)]-2-(4-Fluorophenyl)-β,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic Acid-d5 Calcium Salt (2:1); Atorvastatin D5 p-Hydroxy Analog Calcium; Deuterated Atorvastatin Hydroxy Metabolite; (3R,5R)-7-[2-(4-Fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrol-1-yl]-3,5-dihydroxyheptanoic-d5 Acid Calcium Salt; Isotopically Labeled Atorvastatin Metabolite
EINECS	Contact for details

Quality Control

Our Para-Hydroxy Atorvastatin-D5 Calcium Salt is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and determination of isotopic enrichment. A detailed Certificate of Analysis (COA) is provided with each shipment, ensuring traceability and compliance with your research and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 2-8°C. This product is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator after opening to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥98.0%
Isotopic Enrichment	≥98 atom % D
Chemical Purity	≥95.0%
Water Content (KF)	≤5.0%
Residual Solvents (GC)	Complies with ICH guidelines

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