Description

1,3-Bis(9H-Carbazol-4-Yloxy)-2-Propanol (Carvedilol Impurity) is a high-purity chemical reference standard specifically identified as a process-related impurity of the cardiovascular drug Carvedilol. This compound is critical for pharmaceutical research, development, and quality control, enabling the accurate identification, quantification, and monitoring of this specific impurity during drug substance synthesis. It is an essential material for analytical chemists and quality assurance professionals in the pharmaceutical industry who require reliable reference standards to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of the 1,3-Bis(9H-Carbazol-4-Yloxy)-2-Propanol impurity in Carvedilol Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Used to develop, optimize, and validate sensitive analytical methods, such as HPLC, UPLC, and LC-MS, for impurity profiling.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch release testing to ensure Carvedilol meets stringent pharmacopeial (USP, EP) and ICH guidelines for impurity limits.
• Stability Studies: Employed in forced degradation and long-term stability studies of Carvedilol to track the formation of this impurity under various stress conditions.
• Process Chemistry Research: Used by R&D scientists to study and optimize the Carvedilol synthesis pathway, helping to minimize the formation of this specific impurity.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) submitted to agencies like the FDA and EMA.

Basic Information

Product Name	1,3-Bis(9H-Carbazol-4-Yloxy)-2-Propanol (Carvedilol Impurity)
CAS No.	1276477-91-8
Molecular Formula	C₃₁H₂₆N₂O₃
Molecular Weight	474.55 g/mol
Synonyms	1,3-Bis(9H-Carbazol-4-yloxy)propan-2-ol; 2-Propanol, 1,3-bis(9H-carbazol-4-yloxy)-; Carvedilol Impurity 6; Carvedilol Related Compound 6; Carvedilol Impurity F; 4,4'-(2-Hydroxytrimethylenedioxy)di-9H-carbazole; Bis(4-carbazolyloxy)isopropanol
EINECS	Contact for details

Quality Control

Every batch of 1,3-Bis(9H-Carbazol-4-Yloxy)-2-Propanol is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC, GC, and NMR to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, and residual solvents, supporting your regulatory and quality documentation needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry, well-ventilated area. Keep the container sealed to protect the material from moisture absorption and contamination.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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