Exemestane EP Impurity B
CAS No. | : 184972-09-6 |
Mol F. | : C20H26O3 |
Mol W. | : 314.42 |
Cat No. | : SA19127 |
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Description
Product Name | Exemestane EP Impurity B |
Synonyms | (1S,2R,10R,11S,15S)-8-(Hydroxymethyl)-2,15-dimethyltetracyclo[8.7.0.02,7.011,15]heptadeca-3,6-diene-5,14-dione
6-Hydroxymethylandrostra-1,4-diene-3,17-dione |
Related API | EXEMESTANE |
Category | Impurities |
Exemestane EP Impurity B product with CAS: 184972-09-6 is also known as (1S,2R,10R,11S,15S)-8-(Hydroxymethyl)-2,15-dimethyltetracyclo[8.7.0.02,7.011,15]heptadeca-3,6-diene-5,14-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. It is used in EXEMESTANE impurity profiling as per limits and threshold values specified by respective drug legislation, FDA, and pharmacopoeial guidelines. Moreover, (1S,2R,10R,11S,15S)-8-(Hydroxymethyl)-2,15-dimethyltetracyclo[8.7.0.02,7.011,15]heptadeca-3,6-diene-5,14-dione is also used in the process of Abbreviated New Drug Application (ANDA) filing to FDA and toxicity study of respective drug formulation.
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