Description

Loratadine 2-Chloro Impurity is a key chemical reference standard used in the pharmaceutical development and quality control of the antihistamine drug Loratadine. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark for identifying and quantifying a specific process-related impurity. It is primarily required by analytical laboratories, quality assurance departments, and research & development teams within the global pharmaceutical and fine chemical industries.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of the 2-chloro impurity in Loratadine Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Method Development and Validation: Essential for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and related chromatographic techniques.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor impurity profiles and ensure compliance with stringent pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B guidelines).
• Stability Studies: Employed to track the formation of degradation impurities in Loratadine under various stress conditions (e.g., heat, light, humidity) during drug stability testing.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate control over the manufacturing process and impurity levels.
• Process Chemistry Research: Aids chemists in understanding and optimizing the Loratadine synthesis pathway to minimize the formation of this specific impurity.

Basic Information

Product Name	Loratadine 2-Chloro Impurity
CAS No.	165739-64-0
Molecular Formula	C22H22ClN2O2
Molecular Weight	381.88 g/mol
Synonyms	2-Chloro Loratadine; Loratadine Chloro Impurity; 8-Chloro-6,11-dihydro-11-(1-ethoxycarbonyl-4-piperidinylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridine; Loratadine Impurity C (EP); Loratadine Related Compound C (USP); Desloratadine Process Impurity; Ethyl 4-(8-Chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene)-1-piperidinecarboxylate
EINECS	Contact for details

Quality Control

Our Loratadine 2-Chloro Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided with every shipment, supporting compliance with ICH and relevant pharmacopeial guidelines.

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 low-humidity environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches 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)	≤ 1.0% w/w

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