Methylprednisolone Acetate EP Impurity A

Methylprednisolone Acetate EP Impurity A product with CAS: 93963-74-7 is also known as (20R)-11β,17,20-Trihydroxy-6α-methyl-3-oxopregna-1,4-dien-21-yl Acetate; 6α-Methyl-20(R)-hydroxy Prednisolone 21-Acetate. This product can be used as a working standard or secondary reference standard (additional internal validation as per respective FDA regulations/guidelines may require). Methylprednisolone Acetate EP Impurity A is used in Methylprednisolone Acetate impurity profiling as per limits and threshold values specified by respective drug legislation, FDA, and pharmacopoeial guidelines during commercial production of Methylprednisolone Acetate and its related formulations. Moreover, (20R)-11β,17,20-Trihydroxy-6α-methyl-3-oxopregna-1,4-dien-21-yl Acetate is also used in the process of Abbreviated New Drug Application (ANDA) filing to FDA and toxicity study of respective drug formulation. Please also find out other impurities of Methylprednisolone Acetate developed in our R&D.