Description

Atorvastatin-D5, Sodium Salt is a high-purity, isotopically labeled internal standard critical for ensuring analytical accuracy in pharmaceutical research and development. This deuterated compound is specifically designed for use in quantitative mass spectrometry, providing unmatched precision in the measurement of its parent drug, atorvastatin. It is an essential tool for scientists and quality control professionals in pharmaceutical manufacturing, clinical research, and bioanalytical laboratories who require definitive data for method validation, pharmacokinetic studies, and impurity profiling.

Application

• Quantitative Bioanalysis: Serves as an internal standard in LC-MS/MS and GC-MS methods for the precise quantification of atorvastatin in biological matrices such as plasma, serum, and tissue homogenates.
• Pharmacokinetic and Metabolism Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical research.
• Pharmaceutical Quality Control (QC): Used in assay development and validation to ensure the potency, purity, and consistency of atorvastatin active pharmaceutical ingredient (API) and finished dosage forms.
• Impurity and Degradant Profiling: Aids in the identification and quantification of process-related impurities and degradation products in drug substances and products.
• Regulatory Submissions: Supports the generation of reliable data required for regulatory filings with agencies like the FDA and EMA.
• Stability-Indicating Methods: Integral to developing robust analytical methods that can distinguish the parent drug from its degradation products under various stress conditions.

Basic Information

Product Name	Atorvastatin-D5, Sodium Salt
CAS No.	222412-87-5
Molecular Formula	C33H29D5FN2NaO5
Molecular Weight	~ 581.64 g/mol
Synonyms	Atorvastatin-d5 Sodium Salt; [R-(R*,R*)]-2-(4-Fluorophenyl)-β,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic Acid-d5 Sodium Salt; (3R,5R)-7-[2-(4-Fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrol-1-yl]-3,5-dihydroxyheptanoic Acid-d5 Sodium Salt; Deuterated Atorvastatin Sodium Salt; Atorvastatin D5 Sodium; Lipitor-d5 Sodium Salt (common research name)
EINECS	Contact for details

Quality Control

Every batch of Atorvastatin-D5, Sodium Salt is manufactured and analyzed under strict quality management systems. We guarantee high chemical and isotopic purity, with comprehensive testing including HPLC for chemical purity, NMR and MS for structural and isotopic confirmation, and residual solvent analysis. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results for identity, assay, purity, and deuterium enrichment. Our quality commitment ensures the reliability required for GLP and GMP-compliant research.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dry environment. This product is hygroscopic (moisture-sensitive). For long-term storage, consider desiccant and under an inert atmosphere to maintain stability and purity. Allow the sealed vial to equilibrate to room temperature before opening to minimize moisture condensation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Consistent with molecular structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (Deuterium Enrichment)	≥ 98 atom % D
Chemical Purity	≥ 95.0%
Water Content (KF)	≤ 2.0%
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.