Methylprednisolone EP Impurity L

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 EP Impurity L is chemically 11β,17-dihydroxy-6α-methylpregna-1,4-diene-3,20-dione; 11,17-Dihydroxy-6-methyl-(6α,11β)-pregna-1,4-diene-3,20-dione; 11β,17-Dihydroxy-6α-methyl-pregna-1,4-diene-3,20-dione; 11β,17α-Dihydroxy-6α-methylpregna-1,4-diene-3,20-dione. It is also known as Methylprednisolone Acetate EP impurity I ; Deltamedrane; methylprednisolone acetate; methylprednisolone hydrogen succinate EP impurity G. Methylprednisolone EP Impurity L is supplied with detailed characterization data compliant with regulatory guideline. Methylprednisolone EP Impurity L 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.