Description

Loratadine 8-Bromo Impurity is a key chemical reference standard used in the pharmaceutical development and quality control of the antihistamine drug Loratadine. This impurity, identified by CAS NO 130642-60-3, is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark in analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, process development, and compliance testing. The availability of a well-characterized impurity standard is essential for meeting stringent pharmacopeial requirements and regulatory submissions.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of the 8-Bromo impurity in Loratadine Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical component in developing, optimizing, and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods for impurity profiling.
• Quality Control and Batch Release Testing: Employed in routine QC laboratories to monitor and control the levels of this specific impurity, ensuring every batch of Loratadine API meets predefined specifications.
• Stability Studies: Used to track the formation of degradation impurities in Loratadine under various stress conditions (e.g., heat, light, humidity) as part of drug stability testing protocols.
• Regulatory Compliance and Submissions: Essential for preparing impurity profiles and supporting documentation required for regulatory filings with agencies like the FDA, EMA, and other global health authorities.
• Process Chemistry Research: Aids chemists in understanding and optimizing the synthesis pathway of Loratadine to minimize the formation of this by-product.

Basic Information

Product Name	Loratadine 8-Bromo Impurity
CAS No.	130642-60-3
Molecular Formula	C22H23BrClN2O2
Molecular Weight	455.79 g/mol
Synonyms	8-Bromo Loratadine; Loratadine Impurity B (EP); Loratadine Bromo Impurity; 8-Bromodesloratadine; 8-Bromo-4-(8-chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene)-1-piperidinecarboxylic acid ethyl ester; Ethyl 8-bromo-4-(8-chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene)piperidine-1-carboxylate; Loratadine Related Compound B
EINECS	Contact for details

Quality Control

Our Loratadine 8-Bromo Impurity is manufactured and handled under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, related substance analysis, and structural confirmation via techniques like NMR and Mass Spectrometry, to ensure identity, strength, quality, and purity. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing all test results against stringent in-house specifications aligned with pharmacopeial standards. Our commitment to traceability and documentation supports our clients' needs for regulatory compliance.

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
Heavy Metals	≤ 20 ppm

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