Description

Rupatadine Impurity 7 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 related substances in Rupatadine Fumarate active pharmaceutical ingredients (APIs) and finished drug products. It is an essential tool for analytical chemists, quality assurance professionals, and researchers in pharmaceutical development and manufacturing who require reliable impurity standards to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Characterization: Serves as a certified reference material for method development and validation in HPLC, UPLC, and LC-MS analysis.
• Quality Control and Release Testing: Used as a system suitability standard and for quantifying impurity levels in Rupatadine Fumarate API batches to meet ICH Q3A/B guidelines.
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Pharmacopoeial Testing: Supports compliance testing against monographs from USP, EP, and other international pharmacopoeias.
• Research and Development: Facilitates studies on the degradation pathways, synthesis impurities, and metabolic byproducts of Rupatadine.

Basic Information

Product Name	Rupatadine Impurity 7
CAS No.	1704730-21-1
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 7; Rupatadine EP Impurity G; Rupatadine USP Impurity; Rupatadine Process Impurity; Rupatadine Degradant
EINECS	Contact for details

Quality Control

Every batch of Rupatadine Impurity 7 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assessment, and impurity profiling using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available for audit and regulatory review.

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. The material is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment.

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 individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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