Loratadine EP Impurity A

LC determination of loratadine and related impurities
F.J. Rupe´rez, H. Ferna´ndez, C. Barbas
Journal of Pharmaceutical and Biomedical Analysis 29 (2002) 35–41
 
Measurement and Correlation of Solubility of Loratadine in Different Pure Solvents and Binary Mixtures
Xiujuan Yang,† Shui Wang,† and Jidong Wang
J. Chem. Eng. Data 2017, 62, 1, 391–397

Loratadine EP Impurity A is chemically Ethyl 4-[(11RS)-8-chloro-11-hydroxy-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-yl]piperidine-1-carboxylate (as per EP) ; Ethyl 4-(8-chloro-11-hydroxy-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin- 11-yl) piperidin-1-carboxylate (as per USP). It is also known as Loratadine USP Related Compound F ; Hydroxy Loratadine (USP). Loratadine EP Impurity A is supplied with detailed characterization data compliant with regulatory guideline. Loratadine EP Impurity A can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Loratadine.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. SynZeal products are for analytical purpose only and not for human use.