Description

Rupatadine Impurity B CAS NO 156523-04-5 is a designated reference standard used for the analytical profiling and quality control of the antihistamine drug Rupatadine. This impurity is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It is primarily utilized in research and development, method validation, and stability studies within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Rupatadine Fumarate active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC, to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to confirm that Rupatadine products meet stringent pharmacopeial (e.g., USP, EP) and internal purity specifications.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) to establish shelf life.
• Regulatory Compliance & Filings: Provides necessary data for regulatory submissions (e.g., ANDA, NDA) to agencies like the FDA and EMA, demonstrating thorough impurity characterization.
• Research on Degradation Pathways: Aids in understanding the chemical stability and degradation mechanisms of Rupatadine.

Basic Information

Product Name	Rupatadine Impurity B
CAS No.	156523-04-5
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 B; Rupatadine EP Impurity B; Rupatadine USP Impurity B; Rupatadine Degradant; Rupatadine Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Rupatadine Impurity B is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, GC, MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 COA. Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w
Assay (HPLC)	95.0% - 105.0% on dried basis

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