New LC-MS/MS bioanalytical method for quantification of Estradiol and Estrone
A new method has been successfully developed and validated for determination of Unconjugated Estradiol and Estrone in human plasma by LC-MS/MS with LLOQ of 2 pg/mL and 5 pg/mL respectively.
The method involves a liquid-liquid extraction procedure and a subsequent derivatization procedure. Estradiol, Estrone and internal standards are measured by reversed phase ultra-high performance liquid chromatography coupled to tandem mass spectrometry (UPLC-MS/MS).
The possible metabolite back conversion has been evaluated during method validation.
This method has been successfully used to analyze samples from different clinical studies and the incurred sample reproducibility has met all acceptance crieria.
The development of this assay adds to the list of high sensitivity methods at Anapharm together with Tiotropium, Fluticasone, Salmeterol, Formoterol or Ethinyl Estradiol.
Anapharm Bioanalytics’ successful FDA Inspection
Anapharm Bioanalytics is proud to announce that it has successfully undergone another US FDA inspection at its Barcelona based bioanalytical lab. The inspection, that took place in June 2019, had a focus on a total of 8 studies. This was the second unannounced FDA inspection at our facilities without any observations; no 483 form issued.READ MORE
Anapharm Bioanalytics has been acredited under the Gulf Health Council
Anapharm Bioanalytics is proud to announce that it has been recently added to the List of Bioequivalence Centres Approved by GCC, Gulf Cooperation Council (United Arab Emirates, Bahrain, Kingdom of Saudi Arabia, Sultanate of Oman, Qatar, Kuwait and Republic of Yemen).READ MORE
Anapharm Bioanalytics Brazilian ANVISA Certificate Renewal
Anapharm Bioanalytics is proud to announce that it has recently renewed its ANVISA (Brazil) certificate.
The renewed certification is valid until 11th June 2020.