Description

Labetalol Hydrochloride Impurity 19（(R,S)-Labetalol Hydrochloride） is a critical reference standard used in the pharmaceutical development and quality control of Labetalol Hydrochloride, an important antihypertensive agent. This compound is essential for ensuring the purity, safety, and efficacy of the final drug product by enabling accurate identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, method validation, and compliance testing. The availability of a well-characterized impurity standard is fundamental to meeting stringent pharmacopeial requirements and maintaining robust quality assurance protocols.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of impurities in Labetalol Hydrochloride Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Used to develop, optimize, and validate High-Performance Liquid Chromatography (HPLC), Ultra-High-Performance Liquid Chromatography (UHPLC), and other chromatographic methods for impurity profiling.
• Quality Control (QC) & Stability Studies: Employed in routine batch release testing and forced degradation studies to monitor impurity levels and ensure product stability and shelf-life.
• Regulatory Compliance & Submissions: Critical for preparing regulatory documentation (e.g., for FDA, EMA) to demonstrate thorough impurity characterization as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Research & Development (R&D): Used in synthetic chemistry research to study the formation, fate, and purge of this specific impurity during the API manufacturing process.
• Pharmacopeial Testing: Applied as a system suitability standard in tests described in pharmacopeias such as USP, EP, or BP for Labetalol Hydrochloride monographs.

Basic Information

Product Name	Labetalol Hydrochloride Impurity 19（(R,S)-Labetalol Hydrochloride）
CAS No.	81602-14-4
Molecular Formula	C19H24N2O3 • HCl
Molecular Weight	364.87 g/mol (as hydrochloride salt)
Synonyms	(R,S)-Labetalol Hydrochloride; Labetalol Hydrochloride Racemate; 2-Hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]benzamide Hydrochloride; Labetalol HCl Impurity 19; Labetalol Related Compound 19; 5-[1-Hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]salicylamide Hydrochloride; AH 5158A (Hydrochloride); (±)-Labetalol Hydrochloride
EINECS	Contact for details

Quality Control

Our Labetalol Hydrochloride Impurity 19 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical characterization using advanced techniques including HPLC, GC, NMR, and Mass Spectrometry to confirm identity and purity. A detailed Certificate of Analysis (COA) is provided with each shipment, reporting the results for assay, related substances, residual solvents, and other critical parameters. Our quality standards are designed to support compliance with ICH guidelines and the requirements of major global pharmacopeias.

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 should be handled in a low-humidity environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%
Heavy Metals	≤ 20 ppm

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