Description

Carteolol Hcl Ep Impurity G is a high-purity reference standard and pharmaceutical impurity used in analytical and quality control processes. This compound is critical for ensuring the safety and efficacy of the β-blocker drug Carteolol Hydrochloride by enabling accurate identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and compliance testing. The material is supplied with comprehensive analytical documentation to support stringent quality assurance protocols.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for calibrating analytical instruments and validating testing methods in accordance with ICH guidelines.
• Quality Control (QC) Testing: Used in the routine analysis of Carteolol Hydrochloride Active Pharmaceutical Ingredient (API) and finished drug products to monitor and control impurity levels.
• Research and Development (R&D): Employed in stability studies, degradation pathway elucidation, and impurity profiling during drug development.
• Regulatory Compliance: Essential for preparing documentation for regulatory submissions (e.g., to FDA, EMA) to demonstrate product quality and impurity control.
• Method Development and Validation: A key component in developing and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods for impurity detection.

Basic Information

Product Name	Carteolol Hcl Ep Impurity G
CAS No.	54945-72-1
Molecular Formula	C16H24N2O3 • HCl
Molecular Weight	328.84 g/mol
Synonyms	5-[3-[(1,1-Dimethylethyl)amino]-2-hydroxypropoxy]-3,4-dihydro-2(1H)-quinolinone Hydrochloride; Carteolol Related Compound G; Carteolol Impurity G; Carteolol EP Impurity G; Carteolol Hydrochloride Impurity G; 8-[3-(tert-Butylamino)-2-hydroxypropoxy]-5-hydroxy-3,4-dihydrocarbostyril Hydrochloride; (RS)-5-[3-(tert-Butylamino)-2-hydroxypropoxy]-3,4-dihydrocarbostyril Hydrochloride
EINECS	Contact for details

Quality Control

Every batch of Carteolol Hcl Ep Impurity G is manufactured and tested under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including relevant pharmacopoeial monographs (e.g., EP, USP). Comprehensive characterization is performed using advanced analytical techniques. Certificates of Analysis (COA) detailing purity, identity, and impurity profiles are available upon request to support your regulatory and quality needs.

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 material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants.

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 unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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