Selection of the ‘cleavage tool’ option enables UNIFI to automatically identify fragment ions produced via ring cleavage. To successfully identify degradants relating to the API, potential transformations resulting from degradation were also selected within UNIFI as part of the processing method. Simvastatin and its degradants readily form potassium adducts therefore, the processing method includes + as well as + to automatically assign the detected adducts.
#EASE DIAGNOSTICS KIRK FULL#
Using the full scan with fragmentation function, we can simultaneously acquire both high and low energy spectra, generating fragment ion information for increased confidence in compound identification.
#EASE DIAGNOSTICS KIRK SOFTWARE#
We demonstrate the UNIFI Software automatically identifying and visualizing simvastatin API and the degradants generated. Here, we present the forced degradation of simvastatin under separate acidic, basic and oxidative conditions, as an example of this workflow using the ACQUITY RDa Detector. This capability allows the scientist to use the platform easily and confidently in a regulated environment. This access to HRMS for non-expert users empowers scientists with a far greater depth of analytical information.Īdditionally, the waters_connect Software platform automatically acquires, processes, and reports these results in a compliant-ready framework using dedicated end-to-end SmartMS workflows. The ACQUITY RDa Detector, with its automatic set-up and calibration, allows accurate mass measurements to be obtained by scientists with a diverse range of analytical expertise. This technique usually requires expertise to operate the instruments and interpret the data generated. While UV (Ultraviolet) detection is employed for routine monitoring of degradant products, techniques such as High Resolution Mass Spectrometry (HRMS) are required for initial compound characterisation. Using full scan with both a low and high energy function, the fragmentation cone voltage was ramped, generating fragment ion information, for added structural information.įorced degradation of pharmaceutical drug product and drug substance, as described in FDA and ICH guidelines 3,4, is a vital part of pharmaceutical analytical development, requiring characterization of known and unknown impurities. 2 Separation of the API (Active Pharmaceutical Ingredient) from degradants was achieved using the Waters ACQUITY UPLC I-Class PLUS.Īll the major degradants were automatically identified and degradation profiles over time visualised with mass errors under 3ppm. Here, we demonstrate the forced degradation of simvastatin under acidic, basic and oxidative conditions. 1 High Resolution Mass Spectrometry (HRMS) is a technique often employed to confidently identify chemical components in complex mixtures but requires skilled users for operation and data interpretation. Waters recently introduced the ACQUITY RDa Detector to facilitate the deployment of accurate mass measurement technology, incorporating routine workflows and removing the need for HRMS expertise. Please revert back to before all the changes! This was an amazing app! And now it’s just difficult and annoying, and I hate having to say that.Forced degradation is a critical analytical study for the development of stability-indicating methods used by pharmaceutical companies as part of regulatory submissions to the FDA. Just as I was getting used to the jarring break, I reached a day where the audio *didn’t* work and I sat there like a dummy for a good 30 seconds waiting for the next chapter to play before even checking if something was wrong. Now, however, there’s a good 10-15 seconds of silence between chapters that makes you wonder if the audio is still working. It’s how they would have read them before chapters and verses were added. That actually helped me understand the flow of the story/arguments so much better. It’s no longer easy.Īs well, I *loved* the audio version of the daily reading because it was seem less - no pause between chapters. I use the ChristKirk app specifically for the ease of my daily Bible reading plan.
I have a dedicated Bible app for generic Bible reading. Instead of starting on the plan reading page like before, the reading defaults on Gen 1:1 and I have to search for the plan.
It defaults to NIV (before it was ESV) with no intuitive way to switch back. The look is much less appealing and text is harder to read.
Then it updated and now none of those things are true. It was simple, easy to use, and always worked.
Before a few days ago, I would have given this app 6 out of 5 stars.
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