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Hi René, Thanks for the thoughtful question. I checked with our technical team: • While we haven’t independently characterized the exact degradation pathway for 7-amino analytes in human matrices (e.g., enzymatic vs. hydrolysis vs. other reactions), published work does document stability challenges. Here’s a recent reference on 7-aminoclonazepam stability in urine that you may find useful: https://pmc.ncbi.nlm.nih.gov/articles/PMC11322768/ • Practically, the most reliable way to manage variability is to minimize time-in-use and freeze–thaw exposure: o Use small, single-use aliquots (rather than larger bottles used over multiple days). o Limit hold time after manufacturing when possible (some labs cap 7-amino urine QC at ~1 month post-manufacture for critical applications). o Continue standard best practices: store frozen per IFU, thaw once, keep cold during use, and discard any leftover thawed material. If it would help, we can: • Quote smaller fill sizes/pack counts tailored to single-use, • Coordinate fresh manufacturing with your validation timeline, and • Share our handling/storage IFU highlights specific to 7-amino materials. Please do not hesitate to reach out if you have any questions or require further assistance. Have a wonderful day! Best regards, (Get Help Faster: Include your Customer Identification Number (CID#) in every email, order, or message to UTAK so we can respond without delay.) Quinton Reed Business Development Rep. utak.com – 25020 Avenue Tibbitts Valencia, CA 91355 – D +1.661.456-0116 X164 P +1.888.UTAK.LAB F +1.661.294.9272 Office hours: 8 am - 4:30 pm PST Book a Meeting with Me https://calendly.com/qreed-utak/30min From: Nicole Miller <nmiller@utak.com> Sent: Friday, September 12, 2025 1:18 PM To: Quinton Reed <qreed@utak.com> Subject: Re: Quick Follow-up: Duke University QBR Action Items (CID:013460) Hi Quinton, Here is a study to reference pertaining to stability of 7-aminoclonazepam in urine - https://pmc.ncbi.nlm.nih.gov/articles/PMC11322768/ I can't speak to exactly the method of breakdown as we have not independently studied that mechanism. For customers who are looking for the most stable recovery of 7-amino analytes usually what works best is using the QC material for the least amount of time after manufacturing as possible/feasible. For example, we have another customer who only uses a 7-amino urine product for only 1 month after manufacturing due to the need for a stable result. Let me know if there is anything else I can do to assist! Thank you, Nicole Miller Director of Engineering utak.com – 25020 Avenue Tibbitts Valencia, CA 91355 – P +1.888.UTAK.LAB F +1.661.294.9272 ________________________________________ From: Quinton Reed <qreed@utak.com> Sent: Friday, September 12, 2025 12:21 PM To: Nicole Miller <nmiller@utak.com> Subject: FW: Quick Follow-up: Duke University QBR Action Items (CID:013460) Hi Nicole, Thanks again for the great explanation you shared about the lot-to-lot variability with the 7-amino QC products — that was really helpful. René followed up asking if we could provide more detail on the specific stability challenges. They’re curious whether the variability is driven more by enzymatic breakdown, hydrolysis, or another type of chemical reaction. Could you share any additional insight on what’s most likely happening with these analytes? I’d love to pass that along so they have a full picture of what we’re seeing with 7-amino compounds in human matrices. Appreciate your help as always! Best regards, (Get Help Faster: Include your Customer Identification Number (CID#) in every email, order, or message to UTAK so we can respond without delay.) Quinton Reed Business Development Rep. utak.com – 25020 Avenue Tibbitts Valencia, CA 91355 – D +1.661.456-0116 X164 P +1.888.UTAK.LAB F +1.661.294.9272 Office hours: 8 am - 4:30 pm PST Book a Meeting with Me https://calendly.com/qreed-utak/30min From: Rene Garay <rene.garay@duke.edu> Sent: Friday, September 12, 2025 12:15 PM To: Quinton Reed <qreed@utak.com> Subject: RE: Quick Follow-up: Duke University QBR Action Items (CID:013460) Hello Quinton, Thank you for the information. Would your technical team be able to provide more detail as to the specific stability challenges? Is it enzymatic breakdown, hydrolysis, other chemical reaction? Best, René