Description

Carteolol Hcl Ep Impurity E is a high-purity chemical reference standard, specifically identified as an impurity of the β-blocker Carteolol Hydrochloride. This compound is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing, ensuring the safety and efficacy of the final drug product. It is primarily utilized by research institutions, quality assurance laboratories, and API producers involved in the synthesis and purification of Carteolol Hydrochloride.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for calibrating analytical instruments and validating testing methods.
• Analytical Research & Development: Used in HPLC, LC-MS, and GC-MS studies for the identification and quantification of impurities in Carteolol HCl API and finished dosage forms.
• Quality Control & Assurance: Essential for routine batch testing to monitor impurity profiles and ensure compliance with pharmacopeial limits (e.g., EP, USP).
• Method Development: Aids in developing and optimizing chromatographic separation techniques for related substances testing.
• Stability Studies: Employed as a marker to track degradation pathways and establish the shelf-life of Carteolol-based pharmaceuticals.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).

Basic Information

Product Name	Carteolol Hcl Ep Impurity E
CAS No.	56660-90-3
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 E; Carteolol Impurity E; Carteolol EP Impurity E; 8-[3-(tert-Butylamino)-2-hydroxypropoxy]-5-hydroxy-3,4-dihydroquinolin-2(1H)-one Hydrochloride; (RS)-5-[3-(tert-Butylamino)-2-hydroxypropoxy]-3,4-dihydrocarbostyril Hydrochloride
EINECS	Contact for details

Quality Control

Our Carteolol Hcl Ep Impurity E is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR), purity assessment by HPLC, and determination of residual solvents and moisture content. We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific results and confirms compliance with in-house specifications aligned with pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption, which may affect stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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