Description

Imp. A (Ep): Ethyl 4-[(11Rs)-8-Chloro-11-Hydroxy-6,11-Dihydro-5H-Benzo[5,6]Cyclohepta[1,2-B]Pyridin-11-Yl]Piperidine-1-Carboxylate is a high-purity pharmaceutical intermediate and reference standard, identified by CAS number 38092-95-4. This compound is critical for quality control and research in the development of active pharmaceutical ingredients (APIs), particularly in the antihistamine and anti-inflammatory therapeutic classes. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and R&D facilities for impurity profiling, method validation, and regulatory compliance.

Application

• Pharmaceutical Impurity Standard: Serves as a certified reference material (Impurity A) for the analysis and quantification of related substances in bulk APIs and finished drug products.
• Analytical Research & Development: Used in method development and validation for HPLC, LC-MS, and other chromatographic techniques to ensure accurate impurity detection.
• Quality Assurance/Quality Control (QA/QC): Essential for routine batch testing in pharmaceutical manufacturing to comply with pharmacopeial standards (EP, USP).
• Process Chemistry: Employed as a marker to monitor and optimize synthesis pathways, helping to control and minimize impurity formation during API production.
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Stability Studies: Used to identify and track degradation products in stability testing of pharmaceutical formulations.

Basic Information

Product Name	Imp. A (Ep): Ethyl 4-[(11Rs)-8-Chloro-11-Hydroxy-6,11-Dihydro-5H-Benzo[5,6]Cyclohepta[1,2-B]Pyridin-11-Yl]Piperidine-1-Carboxylate
CAS No.	38092-95-4
Molecular Formula	C22H25ClN2O3
Molecular Weight	400.90 g/mol
Synonyms	Ethyl 4-[(11R)-8-Chloro-11-hydroxy-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-yl]piperidine-1-carboxylate; Loratadine Impurity A (EP); Loratadine Related Compound A; 1-Piperidinecarboxylic acid, 4-[(11R)-8-chloro-6,11-dihydro-11-hydroxy-5H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-yl]-, ethyl ester; Desloratadine Process Impurity; Ethyl 4-(8-chloro-11-hydroxy-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-yl)piperidine-1-carboxylate
EINECS	Contact for details

Quality Control

This high-purity reference standard is manufactured and tested under strict quality management systems. Each batch is analyzed to confirm identity, purity, and impurity profile, ensuring compliance with European Pharmacopoeia (EP) monographs and other relevant regulatory guidelines. Comprehensive Certificates of Analysis (COA) are provided, detailing results from advanced analytical techniques including HPLC, NMR, and MS. Our quality commitment supports your regulatory requirements for pharmaceutical development and commercialization.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is light-sensitive and should be handled under appropriate conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Loss on Drying	≤ 0.5%

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