Description

Loratadine Impurity 28 CAS NO 89979-06-6 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Loratadine. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine quality control testing.

Application

• Pharmaceutical Impurity Profiling and Identification in Loratadine API and finished drug products.
• Analytical Method Development and Validation for HPLC, UPLC, and GC assays.
• Quality Control and Release Testing to monitor and control impurity levels per ICH guidelines.
• Stability Studies to identify and quantify degradation products.
• Regulatory Submissions and Compliance, supporting filings for FDA, EMA, and other global health authorities.
• Research and Development of new synthetic routes and purification processes for Loratadine.
• Calibration Standard for spectroscopic and chromatographic instrumentation.

Basic Information

Product Name	Loratadine Impurity 28
CAS No.	89979-06-6
Molecular Formula	C22H23ClN2O2
Molecular Weight	382.89 g/mol
Synonyms	Loratadine Related Compound 28; 8-Chloro-6,11-dihydro-11-(1-methyl-4-piperidinylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridin-5-one; Desloratadine Impurity; Claritin Impurity 28; Ethyl 4-(8-Chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene)-1-piperidinecarboxylate Impurity
EINECS	Contact for details

Quality Control

Every batch of Loratadine Impurity 28 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity determination and spectroscopic identification, to ensure compliance with ICH Q3A/B guidelines and other relevant pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing identity, purity, and impurity profile is provided with each shipment.

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 must be kept in a desiccated environment to maintain stability and purity.

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)	Single unknown impurity ≤ 0.5% Total impurities ≤ 1.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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