Description

Loratadine Impurity 6 is a specified impurity and degradation product of the widely used antihistamine, Loratadine. This compound is critical for pharmaceutical research and development, serving as a certified reference standard for analytical method validation and quality control. It is essential for manufacturers and analytical laboratories focused on ensuring the purity, safety, and regulatory compliance of Loratadine API and its finished dosage forms.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Loratadine Active Pharmaceutical Ingredient (API).
• Analytical Method Development & Validation (HPLC/GC): Used to develop, calibrate, and validate chromatographic methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Critical for routine batch testing to monitor impurity levels and ensure product specifications are met.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing data for impurity identification and qualification as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Employed to track the formation of degradation products in Loratadine formulations under various stress conditions.
• Research & Development: Used in synthetic chemistry research to study degradation pathways and to develop purer synthetic processes for Loratadine.

Basic Information

Product Name	Loratadine Impurity 6
CAS No.	38093-12-8
Molecular Formula	C22H23ClN2O2
Molecular Weight	382.89 g/mol
Synonyms	8-Chloro-6,11-dihydro-11-(1-methyl-4-piperidinylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridin-5-one; Loratadine Related Compound B; Desloratadine Ethyl Ester; Loratadine EP Impurity B; Loratadine USP Related Compound B; 5H-Benzo[5,6]cyclohepta[1,2-b]pyridin-5-one, 8-chloro-6,11-dihydro-11-(1-methyl-4-piperidinylidene)-
EINECS	Contact for details

Quality Control

Every batch of Loratadine Impurity 6 is manufactured and analyzed under strict quality systems. Our products undergo rigorous identity, purity, and assay testing using validated methods (HPLC, GC, NMR) to ensure compliance with pharmacopeial standards (USP, EP). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), in a dry environment. For long-term storage, consider storing at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (IR)	Conforms to 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
Water Content (KF)	≤ 0.5%
Assay	97.0% - 103.0% (on anhydrous basis)

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