Diclofenac Impurity 1

Diclofenac Sodium Injection Sterilized by Autoclave and the Occurrence of Cyclic Reaction Producing a Small Amount of Impurity
Jiben roy, mafizul islam, anowar h. Khan, subodh c. Das, m. Akhteruzzaman, ajay k. Deb, a. H. Mahbub alam
Journal of Pharmaceutical Sciences Volume 90, Issue 5, May 2001, Pages 541-544
 
A comprehensive strategy in the development of a cyclodextrin-modified microemulsion electrokinetic chromatographic method for the assay of diclofenac and its impurities: Mixture-process variable experiments and quality by design
S Orlandini 1, B Pasquini 2, C Caprini 2, M Del Bubba 3, L Squarcialupi 4, V Colotta 4, S Furlanetto
J Chromatogr A. 2016 Sep 30;1466:189-98.

Diclofenac Impurity 1 is chemically 2-(Dibutylamino)-N-phenylacetamide. Diclofenac Impurity 1 is supplied with detailed characterization data compliant with regulatory guideline. Diclofenac Impurity 1 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 Diclofenac.

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.