Nepafenac Impurity 3

Forced degradation of nepafenac: Development and validation of stability indicating UHPLC method
Mislav Runje 1, Sandra Babić 2, Ernest Meštrović 1, Irena Nekola 1, Željka Dujmić-Vučinić 1, Nina Vojčić
J Pharm Biomed Anal. 2016 May 10;123:42-52.
 
determination of organic volatile impurities in nepafenac by gc method
mariola mucha1 *, aleksandra groman1 , joanna zagrodzka1 and marcin cybulski
Acta Poloniae Pharmaceutica ñ Drug Research, Vol. 71 No. 6 pp. 1013-1022, 2014

Nepafenac Impurity 3 is chemically 2-Amino-3-benzoylbenzoic acid hydrochloride. Nepafenac Impurity 3 is supplied with detailed characterization data compliant with regulatory guideline. Nepafenac Impurity 3 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 Nepafenac.

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.