Description

Di(Atorvastatin-D5) Calcium Salt is a high-purity, deuterated internal standard critical for ensuring analytical accuracy in pharmaceutical research and development. This stable isotope-labeled compound is essential for precise quantification and method validation in mass spectrometry-based assays. It is primarily utilized by analytical chemists, quality control laboratories, and research scientists in the pharmaceutical and contract research organization (CRO) sectors.

Application

• Internal Standard for LC-MS/MS: Used for the accurate quantification of atorvastatin and its metabolites in bioanalytical studies, including pharmacokinetic and pharmacodynamic research.
• Method Development and Validation: Serves as a critical reference material for developing and validating robust analytical methods in compliance with FDA and ICH guidelines.
• Drug Metabolism and Pharmacokinetics (DMPK): Enables precise tracking of drug absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical studies.
• Quality Control and Assurance: Employed in pharmaceutical manufacturing for batch analysis and ensuring the consistency and purity of active pharmaceutical ingredients (APIs).
• Clinical Research: Facilitates therapeutic drug monitoring and biomarker analysis in patient samples.
• Reference Standard: Acts as a certified reference material for calibrating instruments and confirming the identity of atorvastatin in various matrices.

Basic Information

Product Name	Di(Atorvastatin-D5) Calcium Salt
CAS No.	222412-82-0
Molecular Formula	C66H64D5CaF2N4O10
Molecular Weight	~1161.4 g/mol
Synonyms	Atorvastatin-d5 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); (3R,5R)-7-[2-(4-Fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic Acid-d5 Calcium Salt; Deuterated Atorvastatin Calcium; Atorvastatin-d5 Hemicalcium Salt; Lipitor-d5 Internal Standard
EINECS	Contact for details

Quality Control

Our Di(Atorvastatin-D5) Calcium Salt is manufactured under strict quality systems to ensure the high purity and isotopic enrichment required for sensitive analytical applications. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing parameters such as chemical purity, isotopic purity (D5 content), and residual solvent levels. We adhere to relevant industry standards for reference materials to guarantee reliable and reproducible performance in your laboratory.

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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥98.0%
Isotopic Purity (MS)	≥98.0 atom % D (D5)
Water Content (KF)	≤2.0%
Residual Solvents (GC)	Complies with ICH limits
Assay (on anhydrous basis)	97.0% - 103.0%

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