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SCLabGuy

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About SCLabGuy

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  1. Anyone have any experience with Ethan they'd like to share?
  2. I agree wholeheartedly with dhdunbar's analysis. Thank you for taking the time to parse it.
  3. Thanks for the very helpful shortcuts. Two questions: - Can you show your process for arriving at those obscuration numbers? - Using that math, can you consider expanding AlcoDens LQ's "sugar syrup" functionality to be more flexible and allow the calculation of non-sugar obscuration for other ingredients like molasses & glycerine? https://www.fda.gov/media/136289/download Point #6 (I quoted it above)
  4. FDA wants you to proof batches before bottling. This discussion is about that. Designing a batch to land at 80% ABV as you describe, and objectively verifying the alcohol content, are two separate things. Anyone can use hoochware or letsmakesomesanitizer.com and get a formula - that's the easy part.
  5. Here's my guesses - If you use 5% Isopropanol as your denaturant you will have a hard time proofing accurately using normal methods because Iso has a much lower density than ethyl and you've made a mixture. This renders traditionally-calibrated instruments like hydrometers and density meters pretty much useless without a fudge factor of some kind. - If you use formula 40A/40B with denatonium benzoate the application rate is so low (1.7 grams per 100 gallons) that its effect on proof can be ignored safely - Glycerine being much denser than ethyl will have an obscuring effect on the proof (just like sugar syrup or molasses would) - H2O2 is in such a small quantity that I think it will have a very small effect on proof, if any We'll be making a number of large batches in succession and I will test product at each step of the process in a density meter w/ refractometer. If warranted, I will even bench distill a sample. I'll share my findings. FDA told us on the phone (but refused to go on record) that they chose the 80% ABV level because it is thought to be the most effective against COVID-19. That motivates me to get the proof right, even though we do have a rather large window (+/- 5% ABV) as a practical matter.
  6. You're right. It was me that had the two guidance docs backwards.
  7. Neither of the docs that you mention allow Technical Grade Hydrogen Peroxide. My point is that I think YOU are the one that's looking for a loop hole in an "other" document. Specifically the "Compounders" document, which nobody (i.e. TTB or FDA) has said applies to you. We have, of course, been making calls to FDA but they are skittish about going on the record. I maintain that the distinction only matters (technical grade vs. USP h2o2) if you are selling the product, in which case I feel (morally and legally) you have a higher standard of accountability. If you are donating it, I think we all know that the two are functionally equivalent in this particular use case.
  8. TTB guidance: https://www.ttb.gov/public-guidance/ttb-pg-2020-1a Refers specifically to FDA doc 136289 ("firms" and not "compounders") and does so three times. It does not refer to the "compounder" doc (136118) at all. Do you have a source for this claim - that TTB is referring to the "compounding" doc (136118)? I agree that relatively small things would be overlooked in this case. But some DSPs are trying to sell sanitizer in order to stay afloat... and those DSPs would, in my opinion, be wise to toe the line.
  9. This is confusing but I think we (DSPs) actually have to use USP. The "Technical grade" footnote you mentioned appears in an FDA document titled: "Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency Immediately in Effect Guidance for Industry" @ https://www.fda.gov/media/136118/download I believe that guidance is for compounders (i.e. pharmacist-controlled) production facilities that do not normally make sanitizer, allowing them to make it with technical grade peroxide: There is a similar but separate FDA guidance doc titled: "Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-191 ) Guidance for Industry " @ https://www.fda.gov/media/136289/download This one says: I don't think DSPs are Federal compounding facilities - I think they fall under the 2nd doc's umbrella of "firms" that register as OTC manufacturers. Hence, we can only use USP, because the footnote in that doc is missing the technical grade exception. Anyone else got another reading?
  10. Just about an hour ago (weds night) they finally passed the bill and it includes some pretty nice language: No federal excise tax for the entirety of 2020 spirit removals for hand sanitizer. Even bigger is that all you have to do is follow WHO. AND bulk sales / labeling requirements are waived. For once - some decent legislation. Thank goodness. House is supposed to vote on this on Friday AM so CALL YOUR REPS although one would hope this is a no-brainer. Source: https://files.taxfoundation.org/20200325223111/FINAL-FINAL-CARES-ACT.pdf (pg 212-213)
  11. Just a thought... I am not a lawyer and this is not intended to be advice... If you are a DSP who can produce or blend to ~82% ABV (164pf) you have an avenue to help that may be more appealing than actually making sanitizer. Assuming your state law allows it, you can take an existing formula/COLA and print new labels with the proof set to 164 and everything else the same. Batch / distill your product as usual except for the higher proof. Bottle, label, record, pay excise and sell through normal (or non-normal) licensed channels. At this point you are just delivering usual, taxpaid beverage alcohol to a licensee like any other day. The fact that it is at a convenient proof for the end user to add a touch of glycerine and hydrogen peroxide and yield a formula that roughly matches WHO's guidelines is purely coincidental. Bonus points for submitting a formula/COLA that includes Glycerine (a commonly used, food safe additive) at 1.45% to make it even easier. But the method above can be implemented as quickly as you can acquire new labels, and you can probably get that done same-day if you really put your mind to it. This idea, while having drawbacks and requiring the end user to pay at least your laid-in cost plus one cent, is at least free of uncertainty and excess liability. (Handling/bottling 164pf product is dangerous, take proper precautions)
  12. I think you are exactly right. Insert excuses about long days and stress here.
  13. From https://americancraftspirits.org/wp-content/uploads/2017/02/Ethanol-for-Hand-Sanitizer-FINAL-3.24.20.pdf : So. The former FDA guidance implied but did not state outright that denaturing must be done using Isopropyl alcohol. The new FDA guidance gets specific about denaturing, and doesn't allow Isopropyl, but several questions remain: * Are beverage (non-industrial) DSPs actually authorized to denature ethyl alcohol under TTB's emergency guidance? * How can you comply with TTB guidance and produce according to WHO formula, when FDA now specifically forbids any glycerine or hydrogen peroxide? * Where in the )(*#$u&$# are we supposed to get denatonium benzoate, N.F. or the other agents? * Is it even legal to sell (assuming you abide by anti-gouging laws) hand sanitizer to individuals and/or businesses? Above all, I"m just very sad that we (DSPs) appear to be in a worse situation (under even more conflicting guidance) thanks to this updated FDA document. I'm sure our friends at TTB are working hard on this problem, but the uncertainty is tough to bear amid so much other uncertainty.
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