Aceclofenac EP Impurity I

Synchronous UPLC resolution of aceclofenac and diacerin in their powdered forms and matrix formulation: stability study
By Abd El-Rahman, Mohamed K.; Ahmed, Dina A.; Weshahy, Soheir A.; Lotfy, Hayam M.
From Journal of Chromatographic Science (2020), 58(7), 622-628

A validated stability-​indicating method for the estimation of aceclofenac in pharmaceutical dosage form by RP-​HPLC
By Talath, Sirajunisa; Gazi, Shaikh
From American Journal of PharmTech Research (2020), 10(4), 179-196

Stability indicating RP-​HPLC method development and validation for the simultaneous estimation of drotaverine hydrochloride and aceclofenac in bulk and tablet dosage form
By Galla, Rajitha; Uddala, Shyamala; Adepu, Geetha Susmita; Somanjeri, Nithya
From International Journal of Pharmacy and Biological Sciences (2019), 9(2), 1202-1208

Aceclofenac EP Impurity I is chemically 1-(2,6-Dichlorophenyl)-1,3-dihydro-2H-indol-2-one (as per EP). It is also known as Diclofenac-lactam ; Diclofenac Amide ; Diclofenac EP Impurity A ; Diclofenac USP Related Compound A. Aceclofenac EP Impurity I is supplied with detailed characterization data compliant with regulatory guideline. Aceclofenac 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 Aceclofenac.

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.