Sapropterin Impurity 25

HPLC-Based Analysis of Impurities in Sapropterin Branded and Generic Tablets
by Emanuela Scudellaro,Luciana Tartaglione,Fabio Varriale,Carmela Dell’Aversano
and Orazio Taglialatela-Scafati Department of Pharmacy, School of Medicine and Surgery, Universita’ degli Studi di Napoli Federico II, Via D. Montesano, 49, 80131 Naples, Italy
Pharmaceutics 2020, 12(4), 323

Sapropterin Impurity 25 is chemically (Z)-2,6-Diamino-5-(hydroxyimino)pyrimidin-4(5H)-one. Sapropterin Impurity 25 is supplied with detailed characterization data compliant with regulatory guideline. Sapropterin Impurity 25 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 Sapropterin .

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.