Isotretinoin EP Impurity I

Pharmaceutical quality of generic isotretinoin products, compared with Roaccutane
Peter W. Taylor a and Michael H. J. Keenan
Curr Med Res Opin. 2006 Mar;22(3):603-15
 
Improving the Isotretinoin Photostability by Incorporating in Microemulsion Matrix
Mrunali R. Patel,1 Rashmin B. Patel,2 Jolly R. Parikh,2 and Bharat G. Patel
International Scholarly Research Network ISRN Pharmaceutics Volume 2011, Article ID 838016, 6 pages
 
An Efficient Commercial Process for the Preparation of Isotretinoin
Mohammad Salman,* Suresh J. Babu, Vijay K. Kaul, Purna C. Ray, and Naresh Kumar
Organic Process Research & Development 2005, 9, 302−305

Isotretinoin EP Impurity I is chemically (2Z,4E,6E,8E)-9-[(3RS)-3-Hydroxy-2,6,6-trimethylcyclohex-1-en-1-yl]-3,7-dimethylnona-2,4,6,8-tetraenoic acid (13-cis-4-hydroxyretinoic acid). Isotretinoin EP Impurity I is supplied with detailed characterization data compliant with regulatory guideline. Isotretinoin EP Impurity I 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 Isotretinoin.

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.