Description

Loratadine Impurity 30 is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the antihistamine drug Loratadine and its formulations. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and regulatory affairs departments focused on impurity profiling and method validation.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Loratadine Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating stability-indicating HPLC, UPLC, or LC-MS methods for impurity analysis.
• Quality Control & Batch Release: Employed in routine QC testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines, ensuring every batch meets stringent purity specifications.
• Regulatory Submission & Compliance: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and other global health authority requirements.
• Stability Studies: Used as a marker in forced degradation and long-term stability studies to understand the degradation pathways of Loratadine.
• Research & Development: Facilitates impurity isolation, characterization, and toxicological studies during the drug development lifecycle.

Basic Information

Product Name	Loratadine Impurity 30
CAS No.	609806-37-3
Molecular Formula	C22H23ClN2O2
Molecular Weight	382.89 g/mol
Synonyms	Loratadine Related Compound 30; Loratadine EP Impurity J; Loratadine USP Related Compound; 8-Chloro-6,11-dihydro-11-(1-ethoxycarbonyl-4-piperidinylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridine; 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 Impurity 30 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results. Our quality standards align with ICH Q3A(R2) and Q3B(R2) guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material 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 conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
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.