TrustPointe Analytics 🥼

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TrustPointe Analytics 🥼

TrustPointe Analytics 🥼

@TrustPointe

Lab testing per US FDA requirements for consumer injectables • Accuracy Matters. Results You Can Trust. WOSB.

Dorr, MI Katılım Kasım 2024
102 Takip Edilen824 Takipçiler
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TrustPointe Analytics 🥼
TrustPointe Analytics 🥼@TrustPointe·
It’s official 🎉 TrustPointe is a certified Women-Owned Small Business. Proud to work alongside Ashlee, who’s built TrustPointe into a trusted name in peptide analytical testing.
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TrustPointe Analytics 🥼
@ogsvg Are we? Just spent $4k replacing a flow cell on a machine that we bought 6 months ago 😂 I’ll get this completed 👍🏻
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osk
osk@ogsvg·
@TrustPointe Testing labs are in the money printing business rn also brotha I need you to submit evidence under trustpointe on Reptides. You guys have a lab section that’s unclaimed.
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osk@ogsvg·
If most peptides could be orally bioavailable, don't you think they would be delivered that way? Insulin, for example, is around 5800 daltons; Reta is around 4700 daltons. Have you ever heard of people taking insulin pills? No, because they don’t exist! Stop falling for vendor propaganda. They want your money.
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TrustPointe Analytics 🥼
TFA and acetate are counterions, they aren’t actually a part of the molecule, they just balance the charge. If the protein was misfolded, we should see a retention time difference in HPLC. Different salts can also change retention time (BPC acetate vs. arginate). But you should get what you ask for, and TFA isn’t great for you. I don’t have an epitalon method yet, or I’d offer to test both for free to see if we detect the difference.
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Abud Bakri MD
Abud Bakri MD@AbudBakri·
Yikes I always wondered about the variation in effects people report The science on epithalon/epithalamin from Khavinsons lab has been solid and consistent for 45 years But everyone’s getting bunk stuff… Read 👇
BowTied Biohacker@BowTiedUM

Your 99% pure tested Epitalon is probably bunk Especially if it didn't have the typical effects A LOT of the epitalon from chinese suppliers is epitalon trifluoroacetate This is what the manufacturers apparently made a bunch of and are trying to push 40% of the molecule is TFA, it makes epitalon partially misfolded, and it has some toxic properties Now the anecdotes people have shared make more sense If you are a company selling epitalon, you need to ask your chinese sales rep for the following: - Epitalon ACETATE - No TFA, not even trace - Sequence: H-Ala-Glu-Asp-Gly-OH - Anion exchange HPLC - >98% purity by analytic RP-HPLC UV - ESI-MS Confirmation - Net peptide content from AAA, not inferred from gross weight - Ion chromatography with conductivity detection (TFA reported as % w/w and molar equivalents; must be below quantitation limit or absent) - water content - shipping at -20° C with photoprotectant containers Now the fucked up part is they'll still scam you, so you have to confirm all that yourself too Does Finnrick do all of that? No. Does Janoshik? No. That's an issue. At the very LEAST, you need IC counter ion analysis in addition to the standard hplc uv, or else you'll NEVER DISTINGUISH ACETATE FROM TFA AND THATS A HUGE PROBLEM LMFAO For actual research grade (or pharma lmao) epitalon that would have been used in Khavinsons labs, the minimum panel would be: RP-HPLC-UV (purity) + ESI-MS (identity) + AAA (composition) + IC (counter-ion) + elemental N analysis (net content), chiral HPLC (ensure no D contamination) and a TRAP assay(if you reallywanna be legit)

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Vanguard Laboratory
Vanguard Laboratory@Vanguard_Lab·
We have targeted lcmsms screens using 3 mrm transitions to identify 90+ illicit substances, method is validated for peptides, supplements and drinking water, and uses certified referance standards. We have screened more than 10,000 peptides and thus far none have been positive for any opioids, amphetamines, mdma, or related substances. We have also offered to test any presumptive positive results for free, but no one has sent in a vial yet. We have dozens of otc supplements that have tested positive for pd5 Dexamethasone, dicofenac, etc. We certainly have had peptides fail purity testing, or be labeled wrong, but the number pales compared to otc supplements that are currently (loosely) fda regulated.
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TrustPointe Analytics 🥼
I don’t love it, you are opening a closed system and sucking air that is potentially contaminated with microorganisms. Laminar flow hoods exist for this reason. For those saying not to open the plunger and just draw in air, thats the same risk. Probably not the worst risk in this space, but it is a risk. I guess if you have an immune system you might as well put it to work 😂 Someone else posted “just fight the negative pressure like a man”. That’s what I do. If you wanted to be neurotic about it, you could probably draw air into a syringe, put a sterile 0.22um syringe filter on it, then put a sterile needle on the filter, and insert it into the vial, essentially filtering the air coming out of the syringe. Ain’t nobody got time for that.
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MannyJ
MannyJ@mannyjplays·
Quick video on what do if your vial has negative pressure and keeps sucking the peptide back in when you’re trying to draw it out.
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TrustPointe Analytics 🥼
These are kinda easy to spot when you know what you’re looking for. I think the more concerning thing I’m seeing lately is labs offering tests without fully understanding the risks in what they are doing. Like PCR for sterility; it has a high false negative rate. We’ve sent in samples that fail USP <71> for identification with clear growth (turbid solution, CO2 reaction) and PCR will come back inconclusive. In this environment, where nobody knows the formulations of the samples being tested and formulations can interfere with / change test results, you have to be really (really) careful with testing.
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TrustPointe Analytics 🥼
The tells are usually because it’s unrealistic based on an understanding lab testing: Multiple tests being conducted on one vial - pH, sterility, assay, solubility One day turnaround with testing that absolutely takes longer than one day (sterility) The same chromatogram over and over, which you can see by the dates in the injection title
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BowTiedPep
BowTiedPep@BowTiedPep·
Question: what’s stopping someone from setting up a fake testing website? You send your peptides, they wait a few days after receipt and issue a “real” (but fake) COA with identity, purity, endotoxins, etc…searchable with lot and batch numbers…
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TrustPointe Analytics 🥼
TrustPointe Analytics 🥼@TrustPointe·
You should consider grading based on method validation data (accuracy, precision, linearity, forced degradation, etc). You are an objective third party, so labs shouldn’t have a problem sharing that data with you. I’d set up a business doing it, but owning TrustPointe means labs won’t see me as an objective third party. I can teach you what to look for per USP 1225
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Reptides
Reptides@reptidesco·
COA grading will be going live shortly…something we discovered while trying to uncover the actual certificates of trusted labs is that not a single one of the eleven labs we looked at holds a verifiable peptide exclusive accreditation. Ethos Analytics is verified at the issuer level with proper ILAC accreditation through 2028, but their scope doesn't cover peptides, only cosmetics and supplements testing via HPL and ICP methods. Olympic/Vanguard has ALA accreditation for microbiology and metals work through 2027, but peptide purity and identity testing fall outside their accredited scope. Janoshik appears to be community-grade without actual accreditation… their own site makes no ISO claims, though vendors falsely attribute it to them. MZ Biolabs in Tucson has a DEA license but no ISO 17025 accreditation, and ILS Laboratories only self-claims ISO 17025 on their COAs without providing actual certification details or numbers. Freedom Diagnostics holds a CLIA waiver certificate for low-complexity tests only, which doesn't cover high-complexity HPLC/MS work and appears to have lapsed. NuMega Resonance Labs is an NMR/MS contract lab that markets itself as "GLP Compliant" but has no actual ISO 17025 accreditation. The critical finding is that none of these labs appear to be genuinely accredited specifically for peptide testing, the two with real ISO 17025 credentials are accredited for entirely different scopes like cannabis or microbiology.
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TrustPointe Analytics 🥼
TrustPointe Analytics 🥼@TrustPointe·
When we started, it was Jano, MZ, and Chromate. I would add Vanguard based on what I’ve seen for validation paperwork. Everyone else is relatively new (Kovera, Freedom, ILS, etc), so I’d like to see more from them. Honestly, what I really want to do is start a company reviewing method validations and certifying peptide labs. But owning TrustPointe means labs wouldn’t trust me 😂
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Andrew Rivers
Andrew Rivers@AndrewR25833429·
@TrustPointe Who’s considered major labs in your opinion? You included of course
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TrustPointe Analytics 🥼
TrustPointe Analytics 🥼@TrustPointe·
Seeing a lot of angst on the timeline regarding ISO 17025, standardized methods, etc etc. All the major labs (Jano, TP, Chromate, MZ, Vanguard, Freedom, others) have been getting results within +\- 2% of each other for years at this point. Make sure any new lab that pops up validates their methods and move on with life 👍🏻
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TrustPointe Analytics 🥼
TrustPointe Analytics 🥼@TrustPointe·
Still no takers on USP <905> Uniformity of Dosage Units yet. I think the added cost of nine additional vials is turning people off. Someone else offer it for no additional cost already. Ashlee won’t let me. I just want to see some data! 😂
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TrustPointe Analytics 🥼
TrustPointe Analytics 🥼@TrustPointe·
I’d go so far to say it doesn’t add value. China has been the backbone of API manufacturing the US pharmaceutical industry for decades. I’d be more concerned about a US startup fudging it up. Good luck replacing all of your OTC and Rx drugs if you have an issue with APIs coming out of China.
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Kimera Chems
Kimera Chems@KimeraChems·
Back on the Monday grind.
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TrustPointe Analytics 🥼
TrustPointe Analytics 🥼@TrustPointe·
It’s by design. There never will be a single standardized test. It’s just not how the lab industry works. Science and technology moves too fast to be constrained by external mandate, doing so would inhibit innovation. Even with government provided environmental methods (e.g. EPA), I’d bet most environmental labs still tweak the methods and validate that they get the same results. That’s why there are method validation requirements like USP <1225>. As long as Accuracy, Precision, Linearity, Specificity, Range, etc meet the requirements, it doesn’t matter how you get the result because it meets the requirements to be a valid method. The challenge in the peptide industry is the lack of government or registrar oversight of the method validations. It’s why we post ours.
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osk
osk@ogsvg·
@TrustPointe @RegenRandy Yeah I was in another thread with Kimera and we kind of came to the conclusion that the industry is so young there isn’t a single standardized testing process and it can VARY GREATLY depending on lab
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osk
osk@ogsvg·
Damn what I discovered about testing labs actually makes me a bit sad…. None of the ones I held in high regard hold any peptide exclusive testing credentials. Ethos Analytics : they're verified at the issuer level with proper ILAC accreditation through 2028, but their scope doesn't cover peptides, only cosmetics and supplements testing via HPL and ICP methods. Olympic/Vanguard has ALA accreditation for microbiology and metals work through 2027, but again, peptide purity and identity testing fall outside their accredited scope. Janoshik appears to be community-grade without actual accreditation-their own site makes no ISO claims, though vendors falsely attribute it to them. MZ Biolabs in Tucson has a DEA license but no ISO 17025 accreditation, and ILS Laboratories only self-claims ISO 17025 on their COAs without providing actual certification details or numbers. Freedom Diagnostics holds a CLIA waiver certificate for low-complexity tests only, which doesn't cover high-complexity HPLC/MS work and appears to have lapsed. NuMega Resonance Labs is an NMR/MS contract lab that markets itself as "GLP Compliant" but has no actual ISO 17025 accreditation. The critical finding emerging here is that none of these labs appear to be genuinely accredited specifically for peptide testing the two with real ISO 17025 credentials are accredited for entirely different scopes like cannabis or microbiology.
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TrustPointe Analytics 🥼
TrustPointe Analytics 🥼@TrustPointe·
I don’t think they exist today. We have started working on ISO 17025, but I’m a little worried about finding a registrar that will agree to certify peptide methods because of the legality of the space. I won’t say I’m a ISO-certified peptide testing lab without the methods in scope of the certification. While technically true, that crosses a line for me.
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osk
osk@ogsvg·
@RegenRandy Idk but it’s misleading to claim a lab has a certificaiton for testing and have that be basically an umbrella certification for all types of testing. Just not true/accurate.
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TrustPointe Analytics 🥼
TrustPointe Analytics 🥼@TrustPointe·
A lab can produce completely accurate results using a method that isn’t part of their official accreditation. That’s normal. It just means you can’t tell from the certificate alone whether that specific method was validated. We publish our validation data so you don’t have to take our word for it. What I do think crosses a line: putting “ISO certified” on a peptide COA when the peptide methods aren’t actually in the accreditation scope. Technically not a lie. Still misleading. We won’t do it.
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TrustPointe Analytics 🥼
TrustPointe Analytics 🥼@TrustPointe·
Not all vials are created equal. There is random variation that affects every single fill. Some processes are very good and that variation is minimal (e.g. validated filling line). Some processes are very bad and there are wild swings from vial to vial (e.g. hand pipetting to fill vials). The only way to know is perform representative sampling and testing as outlined in this article. We offer USP <905> Uniformity of Dosage Units for those reason. 10 vials tested, and the variation has to be within statistical limits for the test to pass.
Vanguard Laboratory@Vanguard_Lab

You sent one vial to the lab. The report came back clean. Does that mean your entire 500-vial shipment is good to go? No. Before you test, you need a sampling plan based on risk assessment. Full article link below. vanguardlaboratory.com/peptide-and-re…

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