Description

Carvedilol Bisalkylpyrocatechol Impurity is a key chemical reference standard used in the pharmaceutical development and quality control of the cardiovascular drug Carvedilol. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark for impurity identification and quantification. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, process validation, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the analytical method development and validation of Carvedilol API and finished dosage forms.
• Quality Control & Assurance: Essential for routine batch testing to monitor and control the levels of this specific impurity, ensuring drug product specifications are met.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs) and new drug applications (NDAs).
• Stability Studies: Employed to identify and quantify degradation products that may form during the stability testing of Carvedilol under various storage conditions.
• Process Chemistry R&D: Aids in the optimization of Carvedilol synthesis by helping to identify and minimize the formation of this impurity during manufacturing.
• Pharmacopoeial Testing: Used in testing to comply with pharmacopoeial monographs (e.g., USP, EP) that set limits for related substances in Carvedilol.

Basic Information

Product Name	Carvedilol Bisalkylpyrocatechol Impurity
CAS No.	1346602-98-9
Molecular Formula	C24H26N2O4
Molecular Weight	406.48 g/mol
Synonyms	1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]-2-propanol Bisalkylpyrocatechol Impurity; Carvedilol Related Compound; Carvedilol Impurity; Carvedilol Process Impurity; 3-(2-(2-Methoxyphenoxy)ethylamino)-1-((9H-carbazol-4-yl)oxy)propan-2-ol Impurity; Carvedilol Degradant; Carvedilol EP Impurity
EINECS	Contact for details

Quality Control

This high-purity reference material is manufactured and analyzed under strict quality systems. Each batch is characterized using advanced analytical techniques including HPLC, GC-MS, and NMR to confirm identity and purity. A comprehensive Certificate of Analysis (CoA) is provided, detailing batch-specific results and traceability. Our quality commitment aligns with standards relevant to pharmaceutical impurities, supporting compliance in GMP environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to prevent potential oxidation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 2.0%

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