Description

Rupatadine Impurity 3 is a specified impurity used in the quality control and analytical development of the antihistamine drug Rupatadine. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) during manufacturing and regulatory submission. It is primarily required by pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and contract research organizations (CROs) for method validation, stability studies, and reference standard preparation.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Rupatadine Impurity 3 in drug substance and drug product analysis.
• Analytical Method Development and Validation (HPLC/LC-MS): Essential for developing, optimizing, and validating chromatographic methods to monitor this specific impurity as per ICH guidelines.
• Quality Control and Batch Release Testing: Used in routine QC testing of Rupatadine API to ensure impurity levels comply with strict pharmacopeial (e.g., USP, EP) and internal specification limits.
• Stability Studies and Forced Degradation: Employed to identify and track the formation of this impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Compliance and Filing: Critical for preparing regulatory documentation (e.g., for FDA, EMA) to demonstrate comprehensive impurity profiling and control strategies.
• Research on Degradation Pathways: Used in academic and industrial research to study the degradation mechanisms and chemistry of Rupatadine.

Basic Information

Product Name	Rupatadine Impurity 3
CAS No.	156522-82-6
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 C; Rupatadine EP Impurity C; Rupatadine USP Impurity C; Rupatadine Impurity C; 156522-82-6; UNII-9K3F8S3F1R
EINECS	Contact for details

Quality Control

Our Rupatadine Impurity 3 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay, related substance analysis, and confirmatory identification (IR, MS, NMR), to ensure it meets the high standards required for pharmaceutical impurity analysis. Certificates of Analysis (COA) with detailed chromatographic data are provided for traceability and regulatory support.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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