Description

Carteolol Hcl Ep Impurity D 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 drug safety and regulatory compliance. It is an essential material for research and development scientists, quality assurance laboratories, and manufacturers operating under strict pharmacopeial guidelines such as the European Pharmacopoeia (EP).

Application

• Primary use as a pharmacopeial reference standard for the identification and quantification of Carteolol Hydrochloride impurities.
• Analytical method development and validation (HPLC, UPLC, GC) in pharmaceutical quality control laboratories.
• Calibration and system suitability testing for ensuring accuracy in impurity profiling of active pharmaceutical ingredients (APIs).
• Research into the degradation pathways and stability studies of Carteolol Hydrochloride.
• Use in regulatory submissions (e.g., ANDA, NDA) to demonstrate comprehensive impurity control.
• Serving as a critical component in the quality assurance and batch release process for Carteolol-based formulations.

Basic Information

Product Name	Carteolol Hcl Ep Impurity D
CAS No.	51781-13-6
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 D; Carteolol Impurity D; Carteolol Hydrochloride Impurity D; 8-[3-(tert-Butylamino)-2-hydroxypropoxy]-5,6,7,8-tetrahydrocarbostyril Hydrochloride; (RS)-5-[3-(tert-Butylamino)-2-hydroxypropoxy]-3,4-dihydrocarbostyril Hydrochloride; Carteolol EP Impurity D
EINECS	Contact for details

Quality Control

Every batch of Carteolol Hcl Ep Impurity D is manufactured and tested under a strict quality management system. Our products undergo rigorous analytical testing, including HPLC purity assay and identity confirmation (IR, NMR), to ensure compliance with high-purity reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with cGMP and pharmacopeial standards for pharmaceutical impurities.

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 must be kept in a desiccated environment to maintain stability and purity. The container should be kept tightly sealed when not in use.

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 single unknown impurity ≤ 0.5%
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.