Description

Carvedilol N'-β-D-Glucuronide is a major, pharmacologically active metabolite of the β-blocker carvedilol. This compound is of critical importance in pharmaceutical research and development, particularly for metabolism and pharmacokinetic studies. It serves as a vital reference standard for analytical laboratories in the pharmaceutical and biotechnology sectors, enabling accurate quantification and characterization of carvedilol metabolites in biological matrices.

Application

• Pharmaceutical Reference Standard: Primary use as a high-purity certified standard for analytical method development, validation, and quality control in drug metabolism and pharmacokinetics (DMPK) studies.
• Metabolite Identification & Quantification: Essential for identifying and quantifying carvedilol N'-glucuronide in plasma, serum, urine, and other biological samples during clinical and non-clinical trials.
• Bioanalytical Research: Used in LC-MS/MS, HPLC, and other chromatographic assays to understand the metabolic fate, clearance pathways, and exposure levels of carvedilol.
• Drug Interaction Studies: A key analyte in studies investigating the effects of enzyme inducers or inhibitors on carvedilol's metabolism and glucuronidation pathways.
• Impurity Profiling: Employed as a specified impurity standard in the quality control of carvedilol active pharmaceutical ingredient (API) and finished dosage forms.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive characterization data for a significant human metabolite.

Basic Information

Product Name	Carvedilol N'-β-D-Glucuronide
CAS No.	216973-70-5
Molecular Formula	C30H40N2O11
Molecular Weight	604.65 g/mol
Synonyms	Carvedilol N'-Glucuronide; Carvedilol 1'-O-β-Glucuronide; 1-[9-(Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propyl]amino]-1-deoxy-β-D-glucopyranuronic Acid; (2S,3S,4S,5R,6S)-6-[[1-[9H-Carbazol-4-yloxy]-3-[[2-(2-methoxyphenoxy)ethyl]amino]propyl]amino]-3,4,5-trihydroxyoxane-2-carboxylic Acid; Carvedilol Metabolite M14; Carvedilol Glucuronide Metabolite
EINECS	Contact for details

Quality Control

Our Carvedilol N'-β-D-Glucuronide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide a detailed Certificate of Analysis (COA) with each shipment, ensuring traceability and compliance with the stringent requirements for pharmaceutical reference standards. Specifications are aligned with common pharmacopeial expectations for impurity standards.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below for long-term stability. This compound is hygroscopic (moisture-sensitive). Allow the sealed vial to equilibrate to room temperature before opening to minimize moisture uptake. For extended storage, consider under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Consistent with molecular structure
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines
Specific Optical Rotation	Contact for details

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