Description

Loratadine Impurity 13 is a specified impurity used as a certified reference standard in the analytical development and quality control of the active pharmaceutical ingredient (API) Loratadine. This compound is critical for ensuring the purity, safety, and efficacy of antihistamine drug products by enabling accurate identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and compliance with stringent pharmacopeial guidelines (e.g., USP, EP, ICH).

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Loratadine API and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, validating, and transferring chromatographic methods to monitor impurities as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Batch Release Testing: Employed in routine QC testing to ensure Loratadine batches meet specified impurity limits and regulatory requirements.
• Stability Studies: Used to track the formation of degradation products in Loratadine formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., DMF, CMC sections) by providing data on impurity profiles for agencies like the FDA and EMA.
• Research & Development: Aids in the synthesis and purification process development of Loratadine by understanding its impurity pathways.

Basic Information

Product Name	Loratadine Impurity 13
CAS No.	201466-35-5
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; Loratadine EP Impurity C; Loratadine USP Related Compound; Desloratadine Process Impurity; Ethyl Loratadine Impurity; 4-(8-Chloro-5-oxo-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene)-1-methylpiperidine
EINECS	Contact for details

Quality Control

Every batch of Loratadine Impurity 13 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using validated methods (e.g., HPLC, NMR, MS) to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing the analytical results, chromatographic purity, and traceability data.

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 dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (NMR)	Conforms
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%
Single Unknown Impurity (HPLC)	≤ 0.5%
Total Impurities (HPLC)	≤ 2.0%

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