Description

Rupatadine Impurity 13 is a designated chemical reference standard used in 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: Used as a certified impurity standard for the identification and quantification of related substances in Rupatadine active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to separate and detect impurities.
• Quality Control & Assurance (QC/QA): Serves as a system suitability and calibration standard in routine quality control testing to monitor batch-to-batch consistency.
• Stability Studies: Employed to track the formation and level of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs) and investigational new drug (IND) applications.
• Process Chemistry Research: Used to study and optimize synthetic pathways to minimize the formation of this impurity during Rupatadine manufacturing.

Basic Information

Product Name	Rupatadine Impurity 13
CAS No.	732962-71-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Rupatadine Related Compound 13; Rupatadine Impurity K; Rupatadine EP Impurity K; Rupatadine USP Impurity; 8-Chloro-6,11-dihydro-11-(1-[(5-methyl-3-pyridinyl)methyl]-4-piperidinylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridine (Potential IUPAC); Rupatadine Degradation Product; Rupatadine Process Impurity
EINECS	Contact for details

Quality Control

Our Rupatadine Impurity 13 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including chromatographic purity (HPLC), identity confirmation (IR, MS), and residual solvent analysis to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) with batch-specific data is provided, supporting compliance with ICH Q3A/B guidelines and pharmacopeial requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Single Unknown Impurity	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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