Nexaph, EZ, and stateside lyophilization Q
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@Randy I would guess that it’s a quantity issue. Maybe they source them from an outside source. AMP has a few standouts as well.
@Snake-Pepskin ...amp is also the same company.
Its not a quantity issue. They do batches of 20-30k bottles at a time for most things.
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Do they finish stateside because of some import controls on the API's? If they're raw's they get a pass? Trying to understand the advantage to being lypholized here vs China.
@Newenough its not here vs china thats the question. Its who in china vs who here.
Is the facility clean? Are the raws good quality? are they backfilling with nitrogen or skipping that step?
Thats what matters. Nexaph checks all those boxes to my knowledge....and for the 10000th time in case anyone was wondering they give us nothing. Its your easy button.
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@Snake-Pepskin nexaph has provided excipient and raw tests in the past. I know they do it just not how often.
They're essentially the same company.
One question I would raise is ez has things nexaph doesnt. Oxytocin, Reta/cag blend, L-carnitine, kisspeptin etc.
Makes very little sense not to sell kits of those.
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My opinion…
Is stateside lyophilization better over getting finished vials from China?
I would say yes. Not necessarily because it’s in the US, but because it’s done by the actual vendor(in Nexaph’s case at least). Keeps the chain of custody more concise, and the storage and freight more controllable.
Reg the recent endotoxin discovery in some batches, was it introduced in lyophilization and finishing process or came from the raw powders?
I would guess the finishing process. Any decent manufacturer would do full panel test on a large batch of API. However, in the finishing process there are more variables. Vial quality and sterility, dilution ingredients, machinery maintenance and cleaning. Also, since there are only several API manufacturers(rumored), but significantly more finishers, there would be a wider affected percentage if it came from the API.
Do stateside lyophilizers conduct any testing on raw powders before lyophilization?
Rumors are that SNP(Nexaph) Manufactures their own API. This is unsubstantiated to date. If so, they clearly test the API when completed. It just part of the process. If they don’t, it would be silly not to test a batch of bulk API that will fill thousands of vials. It would equate to pennies pre kit.
Rumors are that SNP(Nexaph) Manufactures their own API. This is unsubstantiated to date. If so, they clearly test the API when completed. It just part of the process. If they don’t, it would be silly
Ahh good point. Will try messaging Cain on TG or email and see if he's willing to talk. Finding a reliable source will take so much stress out of RUO research.
The whole new testing lab drama suddenly made US resellers riskier than dark grays. We are supposedly paying for testing and CC checkout markup but cannot be sure of what's in the vials. It has become impossible to find vendors with Vanguard, Trustpointe, or Janoshik COAs. Until 5 months ago there were many.
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Rumors are that SNP(Nexaph) Manufactures their own API. This is unsubstantiated to date. If so, they clearly test the API when completed. It just part of the process. If they don’t, it would be silly
Ahh good point. Will try messaging Cain on TG or email and see if he's willing to talk. Finding a reliable source will take so much stress out of RUO research.
The whole new testing lab drama suddenly made US resellers riskier than dark grays. We are supposedly paying for testing and CC checkout markup but cannot be sure of what's in the vials. It has become impossible to find vendors with Vanguard, Trustpointe, or Janoshik COAs. Until 5 months ago there were many.
@pep_researcher he is talked about it if you search telegram they own there own factory in China where the raws are made. It’s a cgmp facility that follows iso standards. One thing I have noticed is my Reta 50 from crush wasn’t vacuum sealed but it reconstituted fine and I used it with no problems after filtering it
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Where do I buy their stock? Or when is their IPO.
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Rumors are that SNP(Nexaph) Manufactures their own API. This is unsubstantiated to date. If so, they clearly test the API when completed. It just part of the process. If they don’t, it would be silly
Ahh good point. Will try messaging Cain on TG or email and see if he's willing to talk. Finding a reliable source will take so much stress out of RUO research.
The whole new testing lab drama suddenly made US resellers riskier than dark grays. We are supposedly paying for testing and CC checkout markup but cannot be sure of what's in the vials. It has become impossible to find vendors with Vanguard, Trustpointe, or Janoshik COAs. Until 5 months ago there were many.
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@pep_researcher Is Freedom Diagnostics not good?
@ed1 Community has reported some glitches in their results compared to other labs. They are not ISO certified. Vanguard is, Trustpointe was and is getting it renewed.
Having said that I do have quite a bit of my stock with Freedom COAs (bought before knowing more about labs) that I don't plan to trash. Haven't had any issues in research. But that's an orthogonal empirical observation, not necessarily a stamp of approval on Freedom.
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QQ:
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If Nexaph and EZ are the same and EZ lyophilize in the US, does that mean Nexaph stuff is US lyophilized too?
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Is stateside lyophilization better over getting finished vials from China?
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Reg the recent endotoxin discovery in some batches, was it introduced in lyophilization and finishing process or came from the raw powders?
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Do stateside lyophilizers conduct any testing on raw powders before lyophilization?
With the drama around ILS and Kovera, and many original favs moving to them, my vendor choice process needs a revisit.
@pep_researcher the advantage of stateside freeze/drying (lypho) is it allows for better quality control assuming you start with good raw api, but its an art form as each peptide has its own characteristics of sublimation. 2ndly, endo's can be introduced at any stage of production upto sealing the vial and good practice requires having the raw tested just like a vial before starting the process. So the fill finisher should know what the quality is before production and the API may be used in multiple batches when it is bought in the KG sizes. Also, I believe Nexaph is a stateside fill finisher per K-Hole.
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