Description

Desmethyl Cerivastatin-o-B-D-Glucuronide is a key metabolite and reference standard of the HMG-CoA reductase inhibitor cerivastatin. This high-purity compound is essential for pharmaceutical research and development, particularly in the study of drug metabolism and pharmacokinetics (DMPK). It is primarily used by researchers and quality control laboratories in the pharmaceutical and biotechnology industries for analytical method development, bioanalytical studies, and regulatory compliance testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified standard for the quantification and identification of cerivastatin metabolites in biological matrices during clinical and non-clinical studies.
• Drug Metabolism and Pharmacokinetics (DMPK) Research: Used to investigate the metabolic pathways, clearance mechanisms, and bioavailability of cerivastatin.
• Bioanalytical Method Development: Critical for developing and validating sensitive HPLC, LC-MS, or LC-MS/MS methods for pharmacokinetic and toxicokinetic analyses.
• Impurity Profiling and Characterization: Employed as a known impurity or degradation product to ensure the purity and stability of cerivastatin active pharmaceutical ingredient (API).
• Regulatory Compliance and Submission: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive characterization data for metabolites as required by ICH guidelines.
• In Vitro and In Vivo Study Reagent: Used in enzymatic assays and animal studies to understand the pharmacological and toxicological profile of cerivastatin's metabolites.

Basic Information

Product Name	Desmethyl Cerivastatin-o-B-D-Glucuronide
CAS No.	212616-56-3
Molecular Formula	C25H34FNO10
Molecular Weight	527.54 g/mol
Synonyms	BAY w 9798 Metabolite M-1; Cerivastatin Metabolite M1; (3R,5S,6E)-7-[4-(4-Fluorophenyl)-5-(methoxymethyl)-2,6-bis(1-methylethyl)-3-pyridinyl]-3,5-dihydroxy-6-heptenoic Acid β-D-Glucuronide; Desmethyl Cerivastatin Glucuronide; Cerivastatin Hydroxy Acid Glucuronide; M1 Glucuronide of Cerivastatin
EINECS	Contact for details

Quality Control

Our Desmethyl Cerivastatin-o-B-D-Glucuronide is manufactured under strict quality systems to ensure batch-to-batch consistency and high purity, suitable for use as a reference standard. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing results from advanced analytical techniques including HPLC, LC-MS, and NMR for structural confirmation. We adhere to relevant industry guidelines to support your regulatory and research requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dry, cool place. This product is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability and purity. Allow the vial to equilibrate to room temperature before opening to minimize moisture condensation.

Specification

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