D.N.

We(@Vanguard_Lab )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, or contain no peptides at all, but the number pales compared to otc supplements that are currently (loosely) fda regulated.

During yesterday’s FDA Pharmacy Compounding Advisory Committee meeting, PCAC member Dr Melissa Loseke said: “Just last week, I had a patient whose research-grade whatever that they got from wherever was laced with MDMA and ecstasy. That’s not protecting the American people.” I wonder which laboratory tested this mysterious peptide, whatever it was, whether there is a report we can see but most importantly, how on earth the MDMA got there? 👀👀

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.

Correct, this was stated during the meeting yesterday that ecstasy was found in a RUO gray market peptide. You have ZERO clue what’s in your products.

@Krysia830073 Tested using an unvalidated drugstore test strip notorious for cross reactivity. Send us (@Vanguard_Lab)the sample and we will run a targeted low level lcmsms test that is validated for peptides, and supplements.

Another Fentanyl Positive-or is the Lab Only Now Looking? A second product has returned a preliminary result through ILS, raising questions about when routine fentanyl screening began and how reliable the initial test actually is. We now have a second, separate incident involving a product testing preliminarily positive for fentanyl through ILS, this time Glutathione 1500. I have no further information at the moment beyond this announcement, but the first question that comes to mind is: how long has ILS had a policy of routinely testing every sample for fentanyl, and could that help explain the sudden appearance of these results? If this screening was only introduced recently, we may not be seeing a sudden rise in fentanyl contamination. We may simply be seeing the consequences of the lab only recently starting to look for it. It is all fair and good offering additional testing for free, but if the initial screening method has a high false-positive rate, releasing preliminary results before confirmatory testing serves no one. Vendors are immediately placed under suspicion, customers are frightened and rumours spread long before the official COAs are available. Precaution is important, but so is context. ILS needs to explain when routine fentanyl screening began, how many samples have been screened, how many preliminary positives have occurred and what confirmatory method is used before any result is treated as genuine.

@Krysia830073 @Vanguard_Lab is still more than happy to run a targeted lcmsms for free if someone sends a vial

There is more to this 5-Amino-1MQ / fentanyl story than meets the eye. I'm trying to get the vendor to answer some questions but for now this is all we have from her ( her discord profile)

@LarsLundborg @Krysia830073 Yes, we can test it per the USP monograph.

@Dustin_Newman @Krysia830073 Can you test for the identity (and more) of Levetiracetam tablets?

After my article was posted, a second customer came forward with liquid 5-Amino-1MQ reportedly bought from Studz Peptides and sourced from Beeboo. After seeing the report, she tested her product using a CVS urine test. It returned a preliminary positive fentanyl result. The undiluted red liquid could have interfered with a test designed for urine, so this doesn't confirm fentanyl. However, she has now sent an unopened vial to a laboratory for further testing.

Immunoassay strips can produce false positives from cross-reactivity or matrix interference. Running two different strips does not resolve that limitation. The sample should be analyzed using LC-MS/MS with a comparison of retention time and multiple ion transitions. Until that is done, the only conclusion that can be made is that the sample produced presumptive positive immunoassay responses, not that fentanyl was positively identified. If anyone wants independent confirmation, @Vanguard_Lab has certified fentanyl reference standards and an LC-MS/MS method capable of detecting fentanyl in the low-parts-per-billion range. Would be happy to run the sample free of charge and publish the result.

No peptide-specific PT exists, labs can (and do) participate in relevant schemes from ISO 17043-accredited providers. These evaluate the same core analytical techniques and quality systems used in peptide testing: LGC AXIO PHARMASSURE scheme (Pharmaceutical and Dietary Supplements) — This is the closest and most relevant option. It is a broad pharmaceutical PT program covering HPLC assay/purity, impurity profiling/related substances, and other analytical parameters typical of peptide work. Many labs, including Vanguard, participate in LGC’s pharmaceutical PTS as the nearest proxy for demonstrating competence in these methods. It supports ISO/IEC 17025 labs working in pharma, supplements, and similar fields. Related parameter-specific PT schemes (widely available from ISO 17043-accredited providers): Heavy metals by ICP-MS (common in pharma, environmental, and supplement PT schemes). Endotoxin testing (LAL or recombinant factor C methods — available in clinical/pharma PT programs). Sterility and bioburden (USP <61>/<71> style testing — available in pharmaceutical and clinical microbiology PT schemes). These ancillary tests often already have mature PT programs because they apply across pharma, compounding, and other regulated spaces.

Correcting a few things. GLP compliance and ISO 17025 are not the same thing, and one does not substitute for the other. GLP is a quality system for how studies are run. ISO 17025 is competence for specific test methods and scopes. Holding one and not the other isn't a gotcha, it's two different frameworks. More to the point,there is no such thing as accreditation "for peptide testing." Accreditation is method and scope specific. For most of the compounds being tested in this space there are no USP or compendial methods to accredit against, so the lab validates its own in-house method. The reference standard is defined by the lab doing the work. Faulting a lab for lacking a credential that doesn't exist misses the point. NuMega runs NMR and MS. NMR is a small-molecule tool, not the right fit for large peptides. GLP compliant, no ISO, exactly as stated, and appropriate for what they do. MZ Biolabs has no ISO accreditation, correct. They are also the only RUO testing facility running an HRMS Bruker maXis II QTOF from our understanding. Most labs run LRMS or LC-MS/MS, which is perfectly fine for routine peptide work, but for the novel and more complex material we carry, high-res accurate mass actually matters. @Vanguard_Lab is ISO accredited for microbiological testing across multiple matrices and for HPLC methods, holds DOH and DOE accreditation, and is treated as a subject matter expert by the Association of Food and Drug Officials. The rest of the labs on the list I have no stake in defending. On the certificates, they are not misleading. You can pull and verify them yourself. These labs serve many industries, not just RUO vendors. The misread happens when someone takes a certificate scoped for one purpose and reads it as peptide accreditation. That's on the reader, not the lab. Go to any of these labs' own sites and none of them claim to be accredited or expert in peptide testing. Like Ken at MZ told us when we sat down with him: there are 10,000 ways to do this wrong and 100 ways to do it right.

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.

Transparency is important, and I read through the replies as well. There are some good points made, but I think one issue that's causing confusion is the difference between accreditation and certification. ISO/IEC 17025 accreditation isn't a blanket certification that covers everything a laboratory does. It's a third-party assessment of a laboratory's quality system and technical competence for specific methods on its accredited scope. By design, accreditation is scope-specific. What really matters for any analytical method is whether it's properly validated and whether the lab can demonstrate ongoing competency. Proficiency testing is a major part of that when PT programs exist. The challenge with research peptides is that there are very few peptide-specific PT programs available. The closest commercially available proficiency testing for peptide work is the LGC API proficiency testing program, which Vanguard participates in. At Vanguard, all of our analytical methods, including peptide purity, identity, quantification, sterility, endotoxins, and heavy metals are performed under our ISO/IEC 17025 quality management system. Those methods are based on established pharmaceutical, USP, cosmetic, and dietary supplement methodologies and are validated for their intended use. We've also submitted peptide matrices for expansion of our accredited scope covering sterility, endotoxins, heavy metals, and quantification. Beyond our A2LA ISO/IEC 17025 assessments, we're routinely audited by the Washington Department of Ecology, the Department of Health, compounding pharmacies, Fortune 500 clients through vendor qualification programs, tribal governments, local government agencies, and many of our commercial clients. Those audits all evaluate different aspects of our quality system and technical competence. I agree with several of the replies that said method validation is ultimately what matters. Whether a specific peptide appears on an accreditation scope isn't, by itself, the best measure of data quality. A validated method, ongoing quality control, external proficiency testing where available, and regular independent audits provide a much better indication that a laboratory is producing reliable data. I think everyone would benefit from additional standardized peptide-specific PT programs and broader accredited scopes as the industry matures. Until then, the best laboratories are building their programs around validated methods, USP guidance where applicable, available PT such as LGC's Pharma scheme, and third party audits.

@DeckplateOpsO @CrtfdSprvlln total impurity limit for the finished product is not more than 12.0% in finished product per the United States Pharmacoipia. Hgh is rarely >99%

@CrtfdSprvlln I prefer to microdose e.coli thus increasing my available fresh water supply in any give zombie / shtf type scenario.

somatropin is made from e.coli and anything sub 99% purity is dangerous basic research folks

New post on the importance of Statistical risk based sampling plans. vanguardlaboratory.com/peptide-and-re…

🔥🔥🔥🔥🔥TEXAS TAKEOVER🔥🔥🔥🔥🔥 We’d like to welcome @Vanguard_Lab to the list of gold sponsors of the Texas Takeover in Dallas, TX September 25-26. This ain’t the Vanguard you’re thinking about… this is one of the very few analytical laboratories Elite Research trusts with supporting our business with quality assurance / COA tests. They’re one of the biggest in the RUO space that’s actually ISO/IEC 17025 accredited (which ain’t easy). Fast and reliable turnaround times. Truly elite operation. Super pumped to have them. If you haven’t signed up for the Texas Takeover, do it now. Follow link below for speaker lineup (almost finalized), sponsor information/inquiries, and schedule. Please also reach out to me if interested in sponsorship. SPACES ARE LIMITED. texastakeover100.com Thank you @AJA_Cortes, @TJ_Bongiorno, @labs_vanguard, @takegenesis, @Vanguard_Lab, @nick96smart for your contribution towards making this a great conference.

We need a hall of Shame for these.

That's great news, get ready for a lot of control charts, CAPAs and SOPs. we recently submitted our validation packets for the addition of multiple peptide methods to our scope. If you need any assistance on what they will be looking for just let me know. The trickiest part is finding suitable PT testing. We did round robin style testing with Eurofins, and pharma API Pts as a partial substitution since none of the PT providers had peptide samples. If you want to set up Round Robin testing feel free to reach directly dustin@vanguardlaboratory.com ISO/IEC 17025:2017, clause 7.7.2 lists ILCS as a valid alternative.

We’ve engaged a consultant to assist us with implementing ISO 17025. While I have experience implementing FDA, Health Canada, ISO 9001, and ISO 13485 certified quality management systems, I simply don’t have the time to sit down and write 30 SOPs 😂 I’m not sure any of the ISO 17025 labs specifically have their peptide methods within the scope of their certification, so I’m a little concerned about finding a certification body willing to take the risk. We’ll see 🤷🏻‍♂️

@TrustPointe Congrats, Vanguard is Woman owned as well, though we have yet to apply for the SBA certification.

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.

@felixbe54584201 @Krysia830073 What's the peak right before the main peak?

@Krysia830073 We got 99.95% on out Tesa. Is the common or pretty good? 👀

One advantage of having a fake testing lab is that you have the luxury of making up your own results. So if the first attempt isn’t good enough, you may as well go all out with the purity. While even good vendors would struggle to reach this purity, for HGH, Nanjing Peptide does it effortlessly, with a little help from photoshop @bella520zhang

Great article. RP-HPLC/UPLC is still the routine gold standard and workhorse for USP assay's, purity, and related-substances work. For routine purity and quantity, RP-HPLC has been my go-to for the last 25 years. Routine QC usually needs a validated, repeatable analysis to answer a very specific question. LC-MS has a place. We use it all the time. But “LC-MS” is not one thing, and putting “LC-MS” on a COA does not automatically make the COA better. For us Triple quad LC-MS/MS is reserved for trace analysis and targeted low-level quantitation, especially where sensitivity and selectivity matter. We use Orbitrap HRMS when the question is accurate mass, isotope pattern, intact mass confirmation, peptide mapping, impurity ID, degradation products, or unknown troubleshooting. A single quad can be useful as a mass-selective detector or a quick nominal-mass check. But reporting “MW” from a single quad with no mass accuracy, no charge-state/adduct/deconvolution detail, no MS/MS fragments, no reference standard comparison, no method details, and no acceptance criteria is not high-level identity confirmation. It may be supplemental. Retention time by itself is not absolute identity, and co-elution is always a real method-development risk. That is why a real method needs reference standards, system suitability, specificity/selectivity work, forced degradation or stability-indicating work where appropriate, and orthogonal confirmation when the chemistry calls for it. But for routine RUO peptide purity and assay in a relatively clean sample, RP-HPLC is usually the most actionable test. It gives chromatographic purity and quantitative assay against a standard. Where LC-MS is useful: wrong-compound checks, unexpected peaks, co-elution concerns, accurate-mass confirmation, peptide mapping, MS/MS sequencing, trace contaminants, degradation-product ID, and unknown investigations. Where LC-MS is not useful: “MW confirmed” from low-res single quad data, TIC screenshots with no method, no standard, no mass accuracy, no fragments, and no acceptance criteria.

I took some time to address the broken images in our post about Identification by Retention Time. If you’re curious about how HPLC is used for identification per USP, this is the post for you 👍🏻 trustpointeanalytics.com/blogs/trustpoi…

@PeptideRookie We see a good deal of sterility and endotoxin failures. Heavy metals failures are more common with research chems and finished products, but we have seen plenty of peptides fail as well. The failure specs are based on USP/FDA limits which are dose dependent.

I just watched an interview clip with Janoshik where he said most tests for peptides are completely useless (his words) Most of all the heavy metal test! He stated that peptides are used in such minuscule amounts that they’re not a danger in that respect, and out of thousands of tests he’s never had a positive for heavy metals. He stated the best value test is “the identity at the dose” which I’m assuming is underfill/overfill. With the huge push that a lot of RUO companies are doing around testing, it’s Interesting to say the least! #Janoshik #peptides

FYI, For injectable/parenteral products, USP limits for bacterial endotoxins and elemental impurities are often dose-dependent unless a specific limit is provided in the applicable individual monograph. For bacterial endotoxins USP <85>, the limit is generally calculated as K/M. K is the threshold pyrogenic dose, typically 5 EU/kg for most parenteral routes and 0.2 EU/kg for intrathecal administration. M is the maximum recommended dose of product per kg body weight administered in a single one-hour period. The 350 number comes from the FDA, the product can contain up to 350 EU/mL and still meet the calculated safe limit based on the maximum dose a patient would receive. For elemental impurities(Heavy Metals) Daily exposure limits limits can be found in USP <232> Table 1 (or the aligned ICH Q3D values), which are route-specific.