Description

Carvedilol Impurity D is a designated impurity of the widely used β-blocker Carvedilol, identified by the CAS number 1391052-16-6. This compound is critical for pharmaceutical research and development, serving as a key reference standard in the analytical profiling and quality control of Carvedilol active pharmaceutical ingredients (APIs) and finished drug products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure drug purity, safety, and compliance with stringent pharmacopeial standards such as USP and ICH guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Carvedilol Impurity D in drug substances and products.
• Method Development and Validation: Essential for developing and validating robust analytical methods, including HPLC, UPLC, and LC-MS, for impurity profiling.
• Quality Control & Assurance (QC/QA): A critical component in the routine batch release testing of Carvedilol to monitor and control impurity levels as per ICH Q3A/B guidelines.
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation of this specific impurity under various stress conditions.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing necessary impurity characterization data.
• Research & Development: Used in R&D to understand the degradation pathways and synthesis-related impurities of Carvedilol.

Basic Information

Product Name	Carvedilol Impurity D
CAS No.	1391052-16-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Carvedilol Related Compound D; Carvedilol EP Impurity D; Carvedilol USP Impurity D; 1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]-2-propanol Impurity D; BM 14190 Impurity D; (RS)-1-(Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]-2-propanol Impurity D
EINECS	Contact for details

Quality Control

Our Carvedilol Impurity D is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing to ensure high purity and identity confirmation, aligning with current industry and pharmacopeial expectations. A comprehensive Certificate of Analysis (COA) is provided, detailing results for assay, purity, and identification tests. We support compliance with ICH, USP, and EP guidelines for impurities in new drug substances.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to minimize exposure to atmospheric humidity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.1%

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