6β-Methylprednisolone 21-acetate; Methylprednisolone Acetate EP Impurity J
| CAS No. | : 1048031-82-8 |
| Mol F. | : C24H32O6 |
| Mol W. | : 416.51 |
| Cat No. | : SA14422 |
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Description
| Product Name | 6β-Methylprednisolone 21-acetate |
| Synonyms | (6β,11β)-21-(Acetyloxy)-11,17-dihydroxy-6-methylpregna-1,4-diene-3,20-dione
21-Acetyloxy-11ß,17-dihydroxy-6ß-methyl-pregna-1,4-diene-3,20-dione |
| Related API | Methylprednisolone |
| Category | Impurities |
6β-Methylprednisolone 21-acetate product with CAS: 1048031-82-8 is also known as (6β,11β)-21-(Acetyloxy)-11,17-dihydroxy-6-methylpregna-1,4-diene-3,20-dione; 21-Acetyloxy-11ß,17-dihydroxy-6ß-methyl-pregna-1,4-diene-3,20-dione. This product can be used as a working standard or secondary reference standard (additional internal validation as per respective FDA regulations/guidelines may require). 6β-Methylprednisolone 21-acetate is used in Methylprednisolone impurity profiling as per limits and threshold values specified by respective drug legislation, FDA, and pharmacopoeial guidelines during commercial production of Methylprednisolone and its related formulations. Moreover, (6β,11β)-21-(Acetyloxy)-11,17-dihydroxy-6-methylpregna-1,4-diene-3,20-dione 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 developed in our R&D.
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