Mesalazine EP Impurity I

A fast and simple HPLC method for determination of mesalazine impurities A and C in raw material and finished pharmaceutical products
Marjan Piponski, Tanja Bakovska Stoimenova, Irena Slaveska Spirevska, Stefan Stefov, Elena Lazarevska Todevska, Marina Topkoska, Gordana Trendovska Serafimovska
Macedonian Pharmaceutical Bulletin, 66 (Suppl 1) 185 - 186 (2020)
 
Development and Validation of Spectrophotometric Methods for the Determination of Mesalazine in Pharmaceutical Formulation
Fatima Altayib Alasha Abdalla and Abdalla Ahmed Elbashir
Medicinal chemistry Volume 4(3): 361-366 (2014)

Mesalazine EP Impurity I is chemically 2-Hydroxy-5-(phenyldiazenyl)benzoic acid (as per EP). It is also known as Phenylazosalicylic acid (EP). Mesalazine EP Impurity I is supplied with detailed characterization data compliant with regulatory guideline. Mesalazine 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 Mesalazine.

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.