Description

Rupatadine Ep Impurity A CAS NO 1354055-68-7 is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety and efficacy of the antihistamine drug Rupatadine by enabling the accurate identification, quantification, and control of its related substances. It is an essential tool for analytical chemists, quality assurance professionals, and researchers working in pharmaceutical R&D, regulatory compliance, and contract manufacturing organizations (CMOs).

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for the structural elucidation and characterization of impurities in Rupatadine active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity detection and separation.
• Quality Control and Batch Release Testing: Employed in routine QC laboratories to quantify specified impurities, ensuring every batch of Rupatadine API meets stringent pharmacopeial (e.g., EP, USP) and internal specification limits.
• Regulatory Compliance and Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA, CMC sections) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.
• Stability Studies: Used to monitor the formation of degradation products in Rupatadine formulations under various stress conditions (e.g., heat, light, humidity) to establish shelf-life and storage recommendations.
• Pharmacopeial Testing: Acts as a reference standard for compliance testing against monographs in the European Pharmacopoeia (EP) and other international pharmacopeias.

Basic Information

Item	Details
Product Name	Rupatadine Ep Impurity A
CAS No.	1354055-68-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Rupatadine Related Compound A; Rupatadine Impurity A; Rupatadine EP Impurity A; 8-Chloro-6,11-dihydro-11-(1-[(5-methyl-3-pyridinyl)methyl]-4-piperidinylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridine; Rupatadine European Pharmacopoeia Impurity A
EINECS	Contact for details

Quality Control

Our Rupatadine Ep Impurity A is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure high purity and accurate identification. A comprehensive Certificate of Analysis (COA) is provided with every shipment, detailing purity, assay results, and chromatographic data. Our quality standards align with the requirements for pharmaceutical reference standards.

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 Certificate of Analysis. Keep the container in a dry, cool, and well-ventilated area.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Complies
Residual Solvents (GC)	Complies with ICH guidelines

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