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Validation included demonstration of linearity, method precision, accuracy, and specificity in the presence of impurities, excipients for the drug product , and degradation products. Ruggedness and reproducibility of the method were confirmed by collaborative studies between two independent laboratories. The method is being applied for quality control of the API and oral drug product. Direct use of Z -endoxifen may also avoid undesirable drug interactions with SSSRIs which are often prescribed to ameliorate side effects associated with tamoxifen therapy. Endoxifen exists as the potently anti-estrogenic Z -isomer and the lesser known E -isomer. The chemical structures are shown in Fig. The E -isomer of 4-OH-tamoxifen has been found to be estrogenic or weakly anti-estrogenic, while the Z -isomer is a potent antagonist [ 6 ].
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