Description

Levocabastine Related Compound A (50 Mg) (1-[cis-4-Cyano-4-(4-Fluorophenyl)Cyclohexyl]-4-Phenylpiperidine-4-Carboxylic Acid Hydrochloride) is a high-purity reference standard and pharmaceutical intermediate essential for quality control and research. This compound is critical for ensuring the purity, safety, and efficacy of the antihistamine drug levocabastine and related pharmaceutical products. It is primarily used by analytical laboratories, pharmaceutical R&D departments, and quality assurance teams involved in drug development, impurity profiling, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in levocabastine active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, and LC-MS methods for impurity analysis.
• Pharmacological Research: Employed in preclinical studies to understand the metabolism, degradation pathways, and stability profile of levocabastine.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing in pharmaceutical manufacturing to meet stringent pharmacopeial standards (e.g., USP, EP, ICH Q3A/B guidelines).
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings with agencies like the FDA, EMA, and PMDA.
• Chemical Synthesis Research: Acts as a key intermediate or building block in the synthesis of novel chemical entities or analogs for new drug discovery.

Basic Information

Product Name	Levocabastine Related Compound A (50 Mg) (1-[cis-4-Cyano-4-(4-Fluorophenyl)Cyclohexyl]-4-Phenylpiperidine-4-Carboxylic Acid Hydrochloride)
CAS No.	80139-91-9
Molecular Formula	C26H28FN3O2 • HCl
Molecular Weight	477.99 g/mol (Free base: 441.52 g/mol)
Synonyms	1-[cis-4-Cyano-4-(4-Fluorophenyl)Cyclohexyl]-4-Phenylpiperidine-4-Carboxylic Acid Hydrochloride; Levocabastine Impurity A; Levocabastine Related Substance A; Cabastine Related Compound A; (1α,4β)-4-[4-(4-Fluorophenyl)-4-cyanocyclohexyl]-1-phenyl-4-piperidinecarboxylic Acid Hydrochloride; CAS 80139-91-9; Levocabastine HCl Related Compound A
EINECS	Contact for details

Quality Control

This high-grade reference material is produced under strict quality control protocols. Each batch is characterized using advanced analytical techniques including NMR, MS, and HPLC to confirm identity and purity, ensuring compliance with ICH guidelines for impurities. A comprehensive Certificate of Analysis (COA) detailing purity, chromatographic data, and storage recommendations is provided with every unit.

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. This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccant use and storage under inert atmosphere.

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)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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