Description

Labetalol Impurity A is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the antihypertensive drug Labetalol. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Labetalol Impurity A in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, and GC methods to monitor impurities in Labetalol synthesis.
• Quality Control (QC) Testing: Employed in routine QC laboratories to ensure Labetalol batches meet pharmacopeial purity specifications (e.g., USP, EP, ICH guidelines).
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions to determine drug shelf life.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Serves as a key intermediate or marker in synthetic chemistry research and impurity profiling studies for Labetalol.

Basic Information

Product Name	Labetalol Impurity A
CAS No.	1391051-99-2
Molecular Formula	C19H24N2O3
Molecular Weight	328.41 g/mol
Synonyms	5-[1-Hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]salicylamide; Labetalol Related Compound A; Labetalol EP Impurity A; Labetalol USP Impurity A; Labetalol Degradation Product; (2R)-5-(1-Hydroxy-2-{[1-methyl-3-phenylpropyl]amino}ethyl)-2-hydroxybenzamide
EINECS	Contact for details

Quality Control

Our Labetalol Impurity A is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the highest standards for pharmaceutical reference materials. Each batch is characterized and tested for identity, purity, and strength using validated methods such as HPLC, NMR, and Mass Spectrometry. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results against relevant pharmacopeial standards (USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is hygroscopic (moisture-sensitive) and must be kept under inert conditions if the container is opened frequently to prevent degradation.

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)	Any individual impurity ≤ 0.5% Total impurities ≤ 1.0%
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.