Methylprednisolone Hydrogen Succinate EP Impurity B

Methylprednisolone and its related substances in freeze-dried powders for injections
ljiljana solomun1, svetlana ibrić2, vlatka vajs3#, ivan vučković3# and zorica vujić
J. Serb. Chem. Soc. 75 (10) 1441–1452 (2010)
 
Purity evaluation of 6wmethylprednisolone acetate by HPLC
e. ciranni signoretti,* l. valvo, a.l. savella and g. cavina
Journal of Pharmaceutical & Biomedical Analysis Vol. 11, No. 7, pp. 587-593,1993

Methylprednisolone Hydrogen Succinate EP Impurity B is chemically 4-(((6S,8S,9S,10R,11S,13S,14S,17R)-11-hydroxy-17-(2-hydroxyacetyl)-6,10,13-trimethyl-3-oxo-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3H-cyclopenta[a]phenanthren-17-yl)oxy)-4-oxobutanoic acid. It is also known as Methylprednisolone Hemisuccinate USP Related Compound B ; Methylprednisolone 17-Hydrogen Succinate. Methylprednisolone Hydrogen Succinate EP Impurity B is supplied with detailed characterization data compliant with regulatory guideline. Methylprednisolone Hydrogen Succinate 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 Methylprednisolone.

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.