Description

Lobeline Ep Impurity A CAS NO 731823-86-2 is a high-purity chemical reference standard specifically used in the analysis and quality control of Lobeline and its related pharmaceutical substances. This impurity standard is critical for ensuring the safety, efficacy, and regulatory compliance of active pharmaceutical ingredients (APIs). It is an essential tool for analytical laboratories and quality assurance departments within the global pharmaceutical and biotechnology industries, particularly those involved in the development and manufacturing of respiratory and neurological therapies.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify, quantify, and monitor Lobeline Ep Impurity A during API development and manufacturing.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, and LC-MS methods for Lobeline analysis.
• Stability Studies and Forced Degradation Testing: Employed to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Quality Control and Batch Release Testing: Essential for routine QC testing of Lobeline API batches to ensure they meet stringent pharmacopeial (e.g., USP, EP) and ICH guidelines for impurity limits.
• Regulatory Submissions and Compliance: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research and Development: Used in academic and industrial R&D settings to study the metabolism, degradation pathways, and toxicological profile of Lobeline.

Basic Information

Product Name	Lobeline Ep Impurity A
CAS No.	731823-86-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Lobeline EP Impurity A; Lobeline Related Compound A; Lobeline Impurity A; (2R,6S)-2-[(2R)-6-[(2S)-2-Hydroxy-2-phenylethyl]-1-methyl-2-piperidyl]-1-phenylethanone; Lobeline Process Impurity; Lobeline Degradant; Lobeline Specified Impurity
EINECS	Contact for details

Quality Control

Every batch of Lobeline Ep Impurity A is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, LC-MS) and spectroscopic (NMR, IR) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results, including chromatographic purity, assay, and residual solvents, is provided and available upon request to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. For long-term stability, consider storage at 2-8°C. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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