Description

Rosuvastatin Acyl-B-D-Glucuronide is a major metabolite of the widely prescribed statin drug, rosuvastatin. This compound is of critical importance for pharmaceutical research and development, particularly in the study of drug metabolism, pharmacokinetics, and the development of bioanalytical reference standards. It is primarily needed by pharmaceutical companies, contract research organizations (CROs), and academic institutions engaged in drug discovery and safety assessment.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the quantitative and qualitative analysis of rosuvastatin and its metabolites in biological matrices.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Essential for investigating the metabolic pathways, clearance mechanisms, and exposure levels of rosuvastatin in preclinical and clinical research.
• Bioanalytical Method Development and Validation: Used as a critical calibrator and quality control sample in LC-MS/MS and HPLC methods to ensure accurate and reliable assay performance.
• Impurity Profiling and Characterization: Employed to identify, monitor, and quantify process-related or degradation impurities in rosuvastatin active pharmaceutical ingredient (API) and finished dosage forms.
• Toxicology and Safety Assessment: Aids in understanding the safety profile and potential drug-drug interactions associated with rosuvastatin metabolism.

Basic Information

Product Name	Rosuvastatin Acyl-B-D-Glucuronide
CAS No.	503610-44-4
Molecular Formula	C30H39FN3O13S
Molecular Weight	700.71 g/mol
Synonyms	Rosuvastatin Acyl Glucuronide; Rosuvastatin 1-O-β-Acyl Glucuronide; (3R,5S,6E)-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl]-3,5-dihydroxyhept-6-enoic acid β-D-glucopyranosiduronic acid; Rosuvastatin AG; Rosuvastatin Acyl-β-D-Glucuronide; Rosuvastatin Acylglucuronide; Rosuvastatin Metabolite
EINECS	Contact for details

Quality Control

Our Rosuvastatin Acyl-B-D-Glucuronide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, LC-MS for identity confirmation, and residual solvent analysis, to ensure it meets the stringent requirements for pharmaceutical reference standards. Certificates of Analysis (COA) with detailed chromatographic data are provided for every lot.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dry, controlled environment. This product is hygroscopic (moisture-sensitive) and light-sensitive. For long-term storage, keep desiccated under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC/MS)	Conforms to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
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.