Mycophenolate Mofetil EP Impurity B

Forced degradation studies and development and validation of stability-​indicating RP-​HPLC chromatographic method for mycophenolate mofetil assay and related substances
By Singhvi, Indrajeet; Satishchandra, Mehta Hiralben; Raj, Hasumati
From International Journal of Pharmacy and Pharmaceutical Research (2018), 11(4), 14-24
 
First HPTLC method for the simultaneous quantification of tacrolimus sirolimus and mycophenolate mofetil from their pharmaceutical formulations and biological samples
By Pandya, Jui J.; Chavada, Vijay D.; Bhatt, Nejal M.; Sanyal, Mallika; Shrivstav, Pranav S.
From Journal of the Indian Chemical Society (2016), 93(7), 739-750

New stability indicating RP-​HPLC method for estimation of Mycophenolate mofetil capsule in pharmaceutical dosage form
By Kumari, M. Vijaya; Devi, V. Anusha; Nareshbabu, A. V.; Afroz, Patan; Anjaneyulu, V.
From International Research Journal of Pharmaceutical & Applied Sciences (2012), 2(5), 149-154, 6 pp

Mycophenolate Mofetil EP Impurity B is chemically 2-(Morpholin-4-yl)ethyl (4E)-6-[(1RS)-4-hydroxy-6-methoxy-7-methyl-1-[2-(morpholin-4-yl)ethoxy]-3-oxo-1,3-dihydroisobenzofuran-5-yl]-4-methylhex-4-enoate (as per EP); 2-Morpholinoethyl (RS)-(E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-1-(2-morpholinoethoxy)-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate (as per USP) . It is also known as 1-Morpholinoethoxy Mycophenolate Mofetil (USP). Mycophenolate Mofetil EP Impurity B is supplied with detailed characterization data compliant with regulatory guideline. Mycophenolate Mofetil EP Impurity B 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 Mycophenolate Mofetil.

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.