Now available for use on our updated UHPLC method. This method can be utilized for routine testing and beyond use date studies.
Glutathione is now available as an upgraded UHPLC method and can be utilized for routine testing and beyond use date studies. Our validation meets ICH Q2(R1) and USP <1225>. Criteria. This method was created with our innovation and utilizing years of research and development.
The timing for the transition is perfect because our previously used method, DLM 4265, is being removed from our method list and archived. In recent weeks an unknown variable has persisted and failing system suitabilities could not be solved. Any potency testing requested will default to the new method. The pricing will remain the same; we have opted to internally absorb all the method development and validation costs. With the transition to UHPLC we will have more redundancy in instrumentation and a greater consistency in releasing results. This improvement to the methodology will not impact the validity of any previous results or studies.
DYNALABS will transition to the new UHPLC method starting on April 14rd, 2020 because of the unavailability of an alternate method. There may be concern in some cases where a client has a Validation Extension, please contact us so that we can work with you to provide a quotation for Client Formulation Validation. If there are concerns or questions about this transition please email MarketingTechnicalServices@dynalabs.us with any questions or concerns.