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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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.
Anapharm Bioanalytics GLP Certificate Renewal
After the corresponding regulatory inspection Anapharm Bioanalytics has renewed once more its Certificate for Good Laboratory Practice Principles (GLP). The company is under GLP certification since its foundation. The present certificate is valid until June 2020.
READ MOREAnapharm Bioanalytics has participated in the III Workshop on Phase I Clinical Trials
The presentation of our Bioanalytical Coordinator, Araceli Castillo, was focused on two trending topics on Bioanalysis: the final guidance on Bioanalytical Method Validation published by the US FDA on May 21st, 2018 and the progress on the new guideline ICH M10 for the harmonization of bioanalytical method validation.
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