Adapalene EP Impurity B

Isolation and characterisation of impurities in adapalene
Elisabetta Brenna, Samuele Frigoli, Giovanni Fronza, Claudio Fuganti, Federico Sala
Journal of Pharmaceutical and Biomedical Analysis 43 (2007) 1161–1163
 
A High Yield and Pilot-Scale Process for the Preparation of Adapalene
Zhichang Liu and Jiannan Xiang
Organic Process Research & Development 2006, 10, 285−288
 
A Review on a Third Generation Retinoidal Agent: Adapalene
Sadaf Ali, Niharika Rawat, MM. Alam, MS. Zaman and Asif Husain
International Journal of Pharma And Chemical Research, Volume 2,  Issue 1, Jan – Mar, 2016

Adapalene EP Impurity B is chemically 6-[3-(3-Hydroxytricyclo[3.3.1.13,7]dec-1-yl)-4-methoxyphenyl]naphthalene-2-carboxylic acid (as per EP); 6-[3-(3-Hydroxyadamant-1-yl)-4-methoxyphenyl]-2-naphthoic acid (as per USP). It is also known as Hydroxy adapalene (USP). Adapalene EP Impurity B is supplied with detailed characterization data compliant with regulatory guideline. Adapalene EP Impurity B 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 Adapalene.

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.