Description

o-Desmethylcarvedilol is a key pharmacologically active metabolite of the widely used β-blocker and vasodilator, carvedilol. This compound is of significant importance in pharmaceutical research and development, particularly for studying drug metabolism, pharmacokinetics, and the development of analytical reference standards. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and academic institutions engaged in cardiovascular drug development, bioanalytical method validation, and metabolite identification studies.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the quantitative and qualitative analysis of carvedilol and its metabolites in biological matrices.
• Metabolite Research: Critical for pharmacokinetic (PK) and pharmacodynamic (PD) studies to understand the efficacy and safety profile of carvedilol therapy.
• Bioanalytical Method Development: Used as a standard for developing and validating HPLC, LC-MS, and LC-MS/MS methods in clinical and preclinical trials.
• Impurity Profiling: Employed in the identification and quantification of process-related impurities and degradation products in carvedilol active pharmaceutical ingredient (API) manufacturing.
• DMPK Studies: Essential for drug metabolism and pharmacokinetics studies to elucidate the metabolic pathways of carvedilol.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) requiring characterization of major human metabolites.

Basic Information

Product Name	o-Desmethylcarvedilol
CAS No.	72956-44-6
Molecular Formula	C23H26N2O4
Molecular Weight	394.47 g/mol
Synonyms	1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]-2-propanol; 4-Hydroxycarbazol-9-yl 2-[2-(2-methoxyphenoxy)ethylamino]ethyl ether; Carvedilol Metabolite M4; Desmethyl Carvedilol; O-Desmethyl Carvedilol; BM 14190 M4; (RS)-1-(Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]-2-propanol
EINECS	Contact for details

Quality Control

Our o-Desmethylcarvedilol is manufactured under strict quality control protocols to ensure high purity and batch-to-batch consistency suitable for research and analytical applications. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) providing full characterization data including identity (IR, NMR, MS), purity (HPLC), and related substance analysis. We support compliance with ICH guidelines for impurities and can supply material qualified as a pharmaceutical reference standard.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). The product is light-sensitive and should be handled under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥98.0%
Related Substances (HPLC)	Individual impurity ≤0.5%; Total impurities ≤2.0%
Water Content (KF)	≤0.5%
Residue on Ignition	≤0.1%

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