Description

Rupatadine Impurity C is a designated pharmaceutical reference standard used for analytical and research purposes. This compound is critical for ensuring the purity, safety, and efficacy of the antihistamine drug Rupatadine through rigorous quality control processes. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and batch release testing. The availability of a well-characterized impurity standard is essential for compliance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Quality Control (QC): Used as a certified reference material for the identification and quantification of impurities in Rupatadine active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating stability-indicating HPLC, UPLC, or LC-MS methods for Rupatadine.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate thorough impurity profiling and control strategies.
• Stability Studies: Employed to monitor the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the degradation pathways and safety profile of Rupatadine.
• Pharmacopeial Standards: Acts as a potential impurity standard for testing as per monographs in the United States Pharmacopeia (USP) or European Pharmacopoeia (Ph. Eur.).

Basic Information

Product Name	Rupatadine Impurity C
CAS No.	1224515-72-3
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 Degradation Product; Rupatadine Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Rupatadine Impurity C is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive testing including identification (IR, NMR), purity assay (HPLC), and control of related substances and residual solvents to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting compliance with cGMP and relevant pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The material should be kept in a dry environment to prevent moisture uptake. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to 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 guidelines
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.