Description

Labetalol Impurity B is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the antihypertensive drug Labetalol by serving as a key marker for impurity profiling and method validation. It is an essential material for pharmaceutical quality control laboratories, research institutions, and manufacturers engaged in the development and production of Labetalol and its formulations.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Labetalol active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, calibrating, and validating chromatographic methods, such as HPLC and UPLC, to meet ICH Q3A/B guidelines.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor and control impurity levels, ensuring compliance with pharmacopeial standards (USP, EP, BP).
• Stability Studies: Employed as a marker to track degradation pathways and establish the shelf-life of Labetalol formulations under various storage conditions.
• Regulatory Submissions: Supports the preparation of Chemistry, Manufacturing, and Controls (CMC) documentation for regulatory filings with agencies like the FDA and EMA.
• Research & Development: Facilitates synthetic route optimization and process chemistry research by identifying and characterizing process-related impurities.

Basic Information

Product Name	Labetalol Impurity B
CAS No.	802620-01-5
Molecular Formula	C19H24N2O3
Molecular Weight	328.41 g/mol
Synonyms	5-[1-Hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]salicylamide; Labetalol Related Compound B; Labetalol EP Impurity B; Labetalol USP Impurity B; 2-Hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]benzamide; Labetalol Impurity 2
EINECS	Contact for details

Quality Control

Every batch of Labetalol Impurity B is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and traceability conform to the highest standards for reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and storage conditions.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C. Keep the container sealed to protect from moisture.

Specification

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

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