Description

4-Hydroxy Atorvastatin Lactone-D5 is a deuterated analog of a key metabolite of atorvastatin, a widely prescribed statin medication. This compound is of critical importance as a high-purity reference standard and an internal standard for quantitative bioanalytical methods, ensuring accurate pharmacokinetic and metabolic studies. It is primarily needed by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities engaged in drug development, bioequivalence testing, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of atorvastatin metabolites in complex biological matrices.
• Bioanalytical Internal Standard: Used in Liquid Chromatography-Mass Spectrometry (LC-MS/MS) and Gas Chromatography-Mass Spectrometry (GC-MS) assays to improve the accuracy and precision of pharmacokinetic studies.
• Drug Metabolism and Pharmacokinetics (DMPK) Research: Essential for tracing metabolic pathways, studying bioavailability, and understanding the disposition of atorvastatin in preclinical and clinical research.
• Impurity Profiling: Aids in the characterization and control of process-related impurities and degradation products in active pharmaceutical ingredient (API) manufacturing.
• Regulatory Submission Support: Provides critical data for regulatory filings with agencies like the FDA and EMA, supporting New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs).
• Statin Mechanism of Action Studies: Facilitates research into the precise biochemical mechanisms and metabolic fate of HMG-CoA reductase inhibitors.

Basic Information

Product Name	4-Hydroxy Atorvastatin Lactone-D5
CAS No.	265989-49-9
Molecular Formula	C33H29D5FN2O5
Molecular Weight	Contact for details
Synonyms	Atorvastatin 4-Hydroxy Lactone-D5; (3R,5R)-7-[2-(4-Fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic Acid 1,1,3,3,5-Lactone-D5; 4-Hydroxy Atorvastatin D5 Lactone; Deuterated 4-Hydroxy Atorvastatin Lactone; Atorvastatin-d5 Metabolite; 4-OH Atorvastatin Lactone-d5
EINECS	Contact for details

Quality Control

Our 4-Hydroxy Atorvastatin Lactone-D5 is manufactured under strict quality systems suitable for analytical and research applications. Each batch undergoes rigorous analytical testing, including HPLC, NMR, and mass spectrometry, to confirm identity, chemical purity, and isotopic enrichment. Certificates of Analysis (COA) are provided, detailing batch-specific results. We adhere to industry best practices to ensure consistency and reliability for your critical research and development work.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to minimize exposure to atmospheric humidity. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-content)	≥ 98.0 atom % D
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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