Description

Carteolol Impurity H Hcl is a high-purity chemical reference standard specifically identified as an impurity of the β-blocker Carteolol Hydrochloride. This compound is critical for pharmaceutical research and development, enabling precise analytical method development, validation, and quality control processes. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the safety, efficacy, and compliance of Carteolol-based drug substances and products.

Application

• Pharmaceutical Impurity Profiling and Characterization: Serves as a certified reference material for identifying and quantifying Carteolol Impurity H in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development and Validation: Used as a critical standard to establish and validate chromatographic methods, such as HPLC and UPLC, for impurity detection and separation.
• Quality Control and Assurance (QC/QA): Essential for routine batch testing in pharmaceutical manufacturing to monitor impurity levels and ensure they remain within ICH (Q3A, Q3B) regulatory limits.
• Stability Studies: Employed in forced degradation and long-term stability studies of Carteolol Hydrochloride to track the formation of this specific impurity over time and under various stress conditions.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate comprehensive impurity control.
• Pharmacopoeial Standards: Can be used to support the development and verification of monographs for Carteolol Hydrochloride in pharmacopoeias like USP, EP, and BP.

Basic Information

Product Name	Carteolol Impurity H Hcl
CAS No.	53371-79-2
Molecular Formula	C16H24N2O3 • HCl
Molecular Weight	328.84 g/mol (Free base: 292.38 g/mol)
Synonyms	5-[3-[(1,1-Dimethylethyl)amino]-2-hydroxypropoxy]-3,4-dihydro-2(1H)-quinolinone Hydrochloride; Carteolol Related Compound H; Carteolol EP Impurity H; Carteolol USP Impurity H; 8-[3-(tert-Butylamino)-2-hydroxypropoxy]-5-hydroxy-3,4-dihydroquinolin-2(1H)-one Hydrochloride; Carteolol Hydrochloride Impurity H
EINECS	Contact for details

Quality Control

Our Carteolol Impurity H Hcl is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific data and confirms compliance with in-house specifications aligned with ICH guidelines. Our quality commitment ensures the material's suitability for its intended use in regulatory and analytical applications.

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); therefore, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
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.