Description

Loratadine Side Chain Impurity 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 purity and safety profile of the active pharmaceutical ingredient (API) Loratadine, a widely used antihistamine. It is an essential tool for researchers, analytical laboratories, and quality assurance departments involved in method development, validation, and impurity profiling to meet stringent regulatory requirements.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of impurities in Loratadine API.
• Analytical method development and validation (HPLC, GC, LC-MS) in quality control laboratories.
• Critical component in impurity profiling studies to comply with ICH Q3A(R2) and Q3B(R2) guidelines.
• Used in stability studies to monitor degradation pathways of Loratadine formulations.
• Supports regulatory submissions (e.g., for FDA, EMA) by providing characterized impurity data.
• Essential for in-house quality control and batch release testing in API manufacturing facilities.
• Serves as a research chemical for studying the metabolism and synthesis pathways of Loratadine.

Basic Information

Product Name	Loratadine Side Chain Impurity
CAS No.	133345-21-8
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]pyridine; Loratadine EP Impurity C; Loratadine Related Compound C; Desloratadine Synthetic Intermediate; 4-(8-Chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene)-1-methylpiperidine
EINECS	Contact for details

Quality Control

Our Loratadine Side Chain Impurity is manufactured under strict quality systems to ensure batch-to-batch consistency and reliability. Each lot undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, NMR, MS). A detailed Certificate of Analysis (COA) is provided with each shipment, documenting the results against established specifications. Our quality commitment aligns with cGMP principles to support your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider using desiccants.

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)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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