Description

Labetalol Ep Impurity C is a specified impurity and reference standard used in the analytical profiling and quality control of Labetalol, an alpha and beta blocker medication. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, method development, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Labetalol API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or GC methods to monitor process-related impurities.
• Quality Control & Assurance (QC/QA): A critical component in routine batch release testing to ensure Labetalol products meet pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to track the formation of degradation products under various stress conditions, supporting shelf-life determination.
• Regulatory Compliance & Documentation: Used to prepare regulatory submission dossiers (e.g., for FDA, EMA) by providing impurity profile data.
• Process Chemistry Research: Aids in understanding and optimizing the Labetalol synthesis pathway to minimize impurity formation.

Basic Information

Product Name	Labetalol Ep Impurity C
CAS No.	2386661-13-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Labetalol EP Impurity C; Labetalol Related Compound C; Labetalol Impurity C; (2R)-5-[1-Hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]salicylamide; 5-[(1R)-1-Hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]-2-hydroxybenzamide; Labetalol Diastereomer Impurity; Labetalol Process Impurity
EINECS	Contact for details

Quality Control

Our Labetalol Ep Impurity C is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay, identity confirmation (IR, NMR), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated area. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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