Description

Rupatadine Impurity 8 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, enabling the accurate identification, quantification, and monitoring of process-related impurities in Rupatadine drug substances and finished products. It is an essential material for analytical laboratories in the pharmaceutical industry, contract research organizations (CROs), and regulatory bodies focused on ensuring drug safety and efficacy.

Application

• Pharmaceutical Impurity Profiling and Characterization: Serves as a certified reference material for identifying and quantifying this specific impurity in Rupatadine active pharmaceutical ingredients (APIs).
• Method Development and Validation: Used as a critical standard in developing and validating analytical methods, such as HPLC and UPLC, for impurity detection.
• Quality Control and Batch Release Testing: Employed in routine QC laboratories to ensure Rupatadine batches meet stringent purity specifications per ICH guidelines.
• Stability Studies: Used to monitor the formation of degradation products in Rupatadine formulations under various stress conditions.
• Regulatory Submissions and Compliance: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity control strategies.
• Research and Development: Supports process chemistry research to understand and minimize the formation of this impurity during API synthesis.

Basic Information

Product Name	Rupatadine Impurity 8
CAS No.	762214-10-8
Molecular Formula	C26H26ClN3
Molecular Weight	415.96 g/mol
Synonyms	8-Chloro-6,11-dihydro-11-(1-[(5-methyl-3-pyridinyl)methyl]-4-piperidinylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridine; Rupatadine Related Compound 8; Rupatadine EP Impurity H; Rupatadine USP Impurity; Rupatadine Process Impurity; Rupatadine Degradant
EINECS	Contact for details

Quality Control

Every batch of Rupatadine Impurity 8 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC, GC, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A/B guidelines and can supply materials suitable for use under cGMP conditions.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere at -20°C to ensure maximum stability.

Specification

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

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