Nexaph, EZ, and stateside lyophilization Q
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Thanks @stevepep @icynemby @shaqdiesel @researchcat @peptideed What about the other three questions.
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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?
I will message Cain. But wanted to know in general from the community not specific to Nexaph too.
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Thanks @stevepep @icynemby @shaqdiesel @researchcat @peptideed What about the other three questions.
-
Is stateside lyophilization better over getting finished vials from China?
-
Reg the recent endotoxin discovery in some batches, was it introduced in lyophilization and finishing process or came from the raw powders?
-
Do stateside lyophilizers conduct any testing on raw powders before lyophilization?
I will message Cain. But wanted to know in general from the community not specific to Nexaph too.
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Thanks @stevepep @icynemby @shaqdiesel @researchcat @peptideed What about the other three questions.
-
Is stateside lyophilization better over getting finished vials from China?
-
Reg the recent endotoxin discovery in some batches, was it introduced in lyophilization and finishing process or came from the raw powders?
-
Do stateside lyophilizers conduct any testing on raw powders before lyophilization?
I will message Cain. But wanted to know in general from the community not specific to Nexaph too.
Is stateside lyophilization better over getting finished vials from China?
I'm not sure you can say if it is better or worse. It is great when it comes to shipping and availability with them doing that here.Reg the recent endotoxin discovery in some batches, was it introduced in lyophilization and finishing process or came from the raw powders?
I don't know if this could ever be proven. From the things I have read, most people assume the lypho part is where it is introduced but that is only people guessing.Do stateside lyophilizers conduct any testing on raw powders before lyophilization?
I haven't a clue. That is probably a great question for Cain. It would be smart of him to do that to vet good suppliers. Does he? IDK -
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@pep_researcher What "recent endotoxin discovery" are you referring to?
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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.
“Knowledge is the ultimate power.
It’s not what you know that defines you, it’s that which you share that defines you.” -
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.
@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.
"If it doesnt come in a needle. It doesn't work"
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@burner1 Use the search feature on the forum.
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I have to say... my only complaint about Nexaph is the small number of things I'd like to buy they don't carry
@PeptideEd yeah...this
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Are we talking about barn/jeep or was there a endo fail from nexaph im not aware of?
Are we talking about barn/jeep or was there a endo fail from nexaph im not aware of?
Yes the Barn/Jeep one. No endo fail from Nexaph that I'm aware of.
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@randy @peptideed Must say I was completely unaware of all these details of raw procurement and lyophilization etc. Eight months ago I was a newb dipping toes in RUO and a few thumb rules I learned were endotoxin and sterility testing is important.
Since EZ or Nexaph didn't have that, I looked and bought elsewhere. Wasn't even fully aware of testing lab reputation (now I know).
A thought did occur that maybe stateside lyophilizers are better. But LLM tools said nope prefer Chinese industrial lyophilization and finished vial importers over stateside small lyophilization boutiques. Except that the stateside lyophilizers like Nexaph are hardly "small boutiques".
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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.
@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.
“Knowledge is the ultimate power.
It’s not what you know that defines you, it’s that which you share that defines you.” -
@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.
-
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.
@pep_researcher Is Freedom Diagnostics not good?
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