12/17/2017

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.

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31/03/2020 10:03

Anapharm Bioanalytics Brazilian ANVISA Certificate Renewal

Anapharm Bioanalytics is proud to announce that it has recently (February 20th, 2020) renewed its ANVISA (Brazil) certificate. The renewed certification is valid until February 20th, 2022.

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27/01/2020 16:02

Anapharm Bioanalytics Receives Certification for French Research Tax Credit

Anapharm Bioanalytics is pleased to announce it has renewed its French research Tax Credit certification (Crédit d’Impôt Recherche) for period 2020 – 2024.

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12/06/2019 16:28

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.

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