Description

n-Desmethyl Rosuvastatin-D3 is a high-purity, deuterium-labeled internal standard critical for accurate quantitative analysis in bioanalytical and pharmaceutical research. This compound is specifically designed for use in Liquid Chromatography-Mass Spectrometry (LC-MS/MS) methods, providing enhanced precision and reliability for pharmacokinetic and metabolic studies. It is an essential tool for pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories focused on the development and quality control of statin-based therapeutics.

Application

• Primary use as an internal standard for the precise quantification of Rosuvastatin and its metabolites in biological matrices via LC-MS/MS.
• Critical component in pharmacokinetic (PK) and bioequivalence studies to determine drug absorption, distribution, metabolism, and excretion.
• Enables accurate metabolite profiling and identification in drug metabolism and pharmacodynamics (DMPK) research.
• Supports method development and validation in regulatory-compliant analytical laboratories.
• Used in therapeutic drug monitoring (TDM) and clinical research to ensure accurate patient data.
• Essential for impurity characterization and stability testing of Rosuvastatin active pharmaceutical ingredients (APIs).

Basic Information

Product Name	n-Desmethyl Rosuvastatin-D3
CAS No.	371775-74-5
Molecular Formula	C₂₁H₁₈D₃FN₃O₆S
Molecular Weight	~ 484.46 g/mol
Synonyms	Rosuvastatin N-Desmethyl-D3; (3R,5S,6E)-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic Acid N-Desmethyl-D3; Rosuvastatin Impurity D3; Deuterated Rosuvastatin Metabolite; Rosuvastatin-d3 N-Desmethyl Analog; [²H₃]-n-Desmethyl Rosuvastatin
EINECS	Contact for details

Quality Control

Our n-Desmethyl Rosuvastatin-D3 is manufactured under strict quality control protocols to ensure the high chemical purity and isotopic enrichment required for sensitive analytical applications. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing results for identity, purity (HPLC), isotopic purity (D-content), and related substances. We support compliance with ICH guidelines for analytical method validation.

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 handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-content)	≥ 98.0 atom % D
Chemical Purity (by HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity ≤ 1.0%
Total Impurities	≤ 2.0%
Residual Solvents (GC)	Complies with ICH limits

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