Description

Labetalol Ep Impurity D CAS NO 32780-65-7 is a high-purity chemical reference standard, specifically identified as a key process-related impurity in the synthesis of the antihypertensive drug Labetalol. This compound is critical for pharmaceutical research and development, enabling accurate identification, quantification, and control of impurities to ensure drug safety and efficacy. It is an essential material for analytical laboratories, quality control departments, and regulatory affairs teams within the global pharmaceutical and fine chemical industries.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Labetalol Ep Impurity D in active pharmaceutical ingredient (API) batches.
• Method Development and Validation: Critical for developing and validating robust analytical methods (e.g., HPLC, UPLC) for impurity profiling in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance: Used in routine QC testing to monitor and control impurity levels during Labetalol API manufacturing, ensuring final product purity meets pharmacopeial standards (USP, EP).
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough understanding and control of the drug substance impurity profile.
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation of this specific impurity over time and under various stress conditions.
• Research and Development: Supports process chemistry research aimed at optimizing synthesis pathways to minimize the formation of this impurity.

Basic Information

Product Name	Labetalol Ep Impurity D
CAS No.	32780-65-7
Molecular Formula	C19H24N2O3
Molecular Weight	328.41 g/mol
Synonyms	5-[1-Hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]salicylamide; Labetalol Impurity D; Labetalol EP Impurity D; Labetalol Related Compound D; (RS)-5-[1-Hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]salicylamide; Labetalol Hydrochloride Impurity D; UNII-9J8U9Q3B4N
EINECS	Contact for details

Quality Control

Our Labetalol Ep Impurity D is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, identification by spectroscopic methods (IR, NMR, MS), and control of related substances, to ensure it meets the stringent requirements for a pharmaceutical reference standard. Certificates of Analysis (COA) are provided with each shipment, detailing batch-specific results and confirming compliance with relevant specifications.

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); the container must be kept tightly sealed in a dry environment to prevent degradation.

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 individual impurity ≤ 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.