Description

Loratadine Ep Impurity E CAS NO 170727-59-0 is a specified impurity and reference standard used in the analytical profiling of the active pharmaceutical ingredient Loratadine. This compound is critical for pharmaceutical manufacturers and quality control laboratories to ensure the purity, safety, and efficacy of antihistamine drug products. It is primarily required by R&D scientists, analytical chemists, and QC professionals in the pharmaceutical industry for method development, validation, and regulatory compliance testing.

Application

• Primary use as a certified reference standard (CRS) for pharmacopeial testing (EP, USP).
• Critical component in HPLC and LC-MS method development and validation for Loratadine analysis.
• Essential for impurity identification and quantification in stability studies and batch release.
• Used in pharmaceutical research and development to understand degradation pathways.
• Serves as a system suitability standard in quality control laboratories to ensure analytical instrument performance.
• Supports regulatory filings (e.g., ANDA, NDA) by providing impurity characterization data for health authorities.

Basic Information

Item	Detail
Product Name	Loratadine Ep Impurity E
CAS No.	170727-59-0
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 Impurity E; Loratadine EP Impurity E; Loratadine Related Compound E; Desloratadine Impurity; Descarbethoxy Loratadine; 11-(1-Methyl-4-piperidinylidene)-8-chloro-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridin-5-one
EINECS	Contact for details

Quality Control

Every batch of Loratadine Ep Impurity E is manufactured and controlled to meet the stringent requirements for pharmaceutical reference standards. Our quality system ensures compliance with relevant pharmacopeial guidelines (EP, USP). Comprehensive analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis, is performed. A detailed Certificate of Analysis (COA) with batch-specific data 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 dry 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 corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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