cGMP NMR Capabilities

Hi, My name is Dr. Katie Guggenheim. I completed my PhD in synthetic organic Chemistry and also completed a postdoc in Enzyme Engineering, both at UC Davis. Here at Emory Pharma, I oversee our NMR and all the activities that are associated with that. Today I'd like to tell you about our CGMP NMR release testing capabilities. So why do CGMP NMR at all? And why choose Emory Pharma for your GMP NMR needs? What we can do for you is CGMP release and identification testing of your drug, substance or API active pharmaceutical ingredient or drug product of interest. We can also perform release testing on excipients or vehicles used for your pharmaceutical products and even raw materials. All of our analyses are performed under CGMP requirements and are subject to FDA inspection. We can perform USP or EP monographs of interest. Typically, we will run a verification of these methods before release testing to be certain they are suitable for our site and instrument. We can develop and fully validate new methods if a monograph is not available customized to your needs. Our NMR is capable of multinuclear detection including proton, carbon, fluorine, nitrogen, phosphorus and many more. So so what does Emory Pharma bring to the table to get this work done? We have NMR experts and highly trained analysts on our team to perform development and validation of these methods and eventual release testing assays. We have a rigorous quality management system and a full QA department which keep us in compliance with CGMP and GLP guidelines. Our 400 MHz NMR is very well maintained and always up to date on iq, OQ and PQ which is installation, operational and performance qualification. So what do we expect you to bring to the table as the client? What we will ask from you is that you give us a full background and scope of your project, including where your product might stand in the regulatory process and of course the structure and all information available for your material of interest. This also includes your timeline expectation. Emory Pharma is capable of providing rush services if necessary. We will also need a certified reference standard or spectrum either provided by you as the client or obtained by Emory Pharma. We will also need the USP or EP monograph that you would like performed or if a customized method is necessary. Any background information about this method that is available to you will be requested. Of course we will need your material for eventual release testing. Please fill out our form that you can find on the Contact us page@emorypharma.com and we look forward to collaborating with you and your team soon.