Description

Pitavastatin-D4 CAS NO 2070009-71-9 is a high-purity, deuterium-labeled internal standard of the cholesterol-lowering drug Pitavastatin, essential for ensuring accuracy and reliability in quantitative bioanalytical research. This stable isotope-labeled compound is critical for applications requiring precise measurement and validation, such as pharmacokinetic studies and drug metabolism research. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities focused on method development and regulatory compliance.

Application

• Internal Standard for LC-MS/MS Analysis: Used as a quantitative reference in the bioanalysis of Pitavastatin in biological matrices like plasma, serum, and urine.
• Pharmacokinetic (PK) and Pharmacodynamic (PD) Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) in clinical and pre-clinical trials.
• Drug Metabolism Research: Facilitates the identification and quantification of metabolites in metabolism and stability studies.
• Method Development and Validation: Serves as a critical component in developing and validating robust, GLP-compliant analytical methods for regulatory submissions.
• Quality Control in Pharmaceutical Manufacturing: Can be employed in impurity profiling and assay verification of Pitavastatin active pharmaceutical ingredients (APIs) and finished dosage forms.

Basic Information

Product Name	Pitavastatin-D4
CAS No.	2070009-71-9
Molecular Formula	C₂₅H₂₀D₄FNO₄
Molecular Weight	~425.5 g/mol
Synonyms	Pitavastatin-d4; (3R,5S,6E)-7-[2-Cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl]-3,5-dihydroxy-6-heptenoic-3,5,6,7-d4 Acid; Livalo-d4; NK-104-d4; ITAV-304-d4; Deuterated Pitavastatin; Pitavastatin (tetradeuterated)
EINECS	Contact for details

Quality Control

Our Pitavastatin-D4 is manufactured under strict quality control protocols to ensure the highest standards of isotopic purity and chemical integrity, suitable for sensitive analytical applications. Each batch is accompanied by comprehensive analytical documentation, including HPLC chromatograms and MS spectra. Certificates of Analysis (COA) detailing isotopic enrichment (typically ≥98% D), chemical purity (by HPLC), and other critical parameters are provided to guarantee consistency and traceability for your research needs.

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 material is hygroscopic (moisture-sensitive) and should be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥98.0%
Isotopic Purity (D-enrichment)	≥98.0 atom % D
Chemical Purity (by HPLC)	≥98.0%
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.