MESO-Rx Sponsor Primal Pharma - US Domestic

Thank you for sharing. Sincerely. The GC row (row 9) has my antenna going up. "GC" on its own is not an analytical method. Same with residual solvents. Was this an area count method or did the vendor use total mass weight vs measured mass of API? Each test should reference a USP method.

@janoshik, care to comment on this COA? Reaction?

@Primal_Pharma, how does purity in COA compare to estimate purity from the batch you made? Compare the measured amounts in your batch recipe to the HPLC results you shared to get an estimated purity.
Appreciate the thoughtful response, brother and fair questions.

You’re right, “GC” alone isn’t a complete analytical method. This particular COA uses Gas Chromatography by area %, which is a common practice for raw material assay. It’s not mass-spec based or HPLC-weighted, just standard GC area normalization, which is what most major raw suppliers rely on for initial potency confirmation.

Same with the residual solvents, it’s GC headspace, not LC-MS or anything fancy. But everything is well within USP thresholds, and the solvents flagged are minimal, if present at all.
 
keeping us on our toes, it forces us to stay sharp. But damn man… you really are committed to being a thorn in the side.

You’re relentless, I’ll give you that. Just don’t disappear when the receipts show up.
I've been in your shoes, sort of. I've presented some product to the executive suite and said it provides, let's say, "real-time data analytics". And what I meant, and more importantly what I knew the buying decision-makers would interpret it to mean, is "interactive analytics that run fast enough to make you happy."

That's when some pedantic motherfucker from the engineering team, for whom I have an entirely different presentation that doesn't (mis)use a term of art like that, pops up and says "oh really? Your platform provides guaranteed bounded latency for arbitrary analytical queries?" with a scoff and a tip of the fedora. And then I've got to walk it back and explain what colloquial meaning we're using, and what our actual guarantees and latencies are, and of course more complex queries take more time, blah blah blah. It's annoying, but if we can't answer that guy, then he'll keep chipping away at our credibility and reputation within the company and we'll never get the sale, because in his mind, if we're wrong about something as basic as that, nothing we say is trustworthy.

He will do that even if he's used the product and found it satisfactory. That's not good enough. Somebody is wrong on the Internet.

Now you've got a pedantic motherfucker popping up and calling you out on some claims that most of us just ignored or interpreted in some way that made more sense. Maybe some of the duller knives in the drawer believed you literally, I don't know, but I doubt many did. So maybe "Pharma grade flow hood" really means "I bought a flow hood from a legitimate medical/lab equipment supplier and its specs are pretty good and we didn't just knock something together out of plywood", and maybe "pharma quality APIs" means "tests at 99% or greater purity". If you really are better than the next guy, that's enough to win all the business you want. Just tell us what you really meant and then back it up.

We don't really know what you mean, though, unless you tell us, and we don't know if we can trust those claims unless you provide evidence. Maybe there's a huge surprise here and you really do comply with a bunch of pharma manufacturing standards. There's not much point in doing that, though, unless you get some credit for it. Showing evidence would get you some credit.

But literally nobody expects that to be the case. If you responded to @readalot and said "we kind of misspoke on 'pharma grade' and actually should have said 'blah', which we think is quite good compared to others and entirely sufficient for this application", what most of us would hear is the good stuff. We're not going to clutch our pearls because you clarified that a statement we never believed or gave you any credit for in the first place isn't true.

Please help put this debate to rest and take your thread back. Just answer the damn questions.
 
Appreciate the thoughtful response, brother and fair questions.

You’re right, “GC” alone isn’t a complete analytical method. This particular COA uses Gas Chromatography by area %, which is a common practice for raw material assay. It’s not mass-spec based or HPLC-weighted, just standard GC area normalization, which is what most major raw suppliers rely on for initial potency confirmation.

Same with the residual solvents, it’s GC headspace, not LC-MS or anything fancy. But everything is well within USP thresholds, and the solvents flagged are minimal, if present at all.
So we are getting somewhere. We agree then this is your common area count BS COA you get from "generic" vendors. The purity result means nothing. And I am not saying that to cast dispersions your way. Your best bet is to accurately measure raw purity via HPLC with calibrated detector. Still interested in what your estimated purity was as inferred from your batch results.

Thank you.
 
Appreciate the thoughtful response, brother and fair questions.

You’re right, “GC” alone isn’t a complete analytical method. This particular COA uses Gas Chromatography by area %, which is a common practice for raw material assay. It’s not mass-spec based or HPLC-weighted, just standard GC area normalization, which is what most major raw suppliers rely on for initial potency confirmation.

Same with the residual solvents, it’s GC headspace, not LC-MS or anything fancy. But everything is well within USP thresholds, and the solvents flagged are minimal, if present at all.
NICE.
 
So we are getting somewhere. We agree then this is your common area count BS COA you get from "generic" vendors. The purity result means nothing. And I am not saying that to cast dispersions your way. Your best bet is to accurately measure raw purity via HPLC with calibrated detector. Still interested in what your estimated purity was as inferred from your batch results.

Thank you.
So the COA gives us the raw material purity (99.4%) before it’s ever touched a beaker. What we measure on our end (once brewed) is based on finished product concentrations, usually confirmed through HPLC or mass spec, depending on the lab and batch.

If you’re asking how our measured amounts compare: everything is dosed to label based on the raw’s assay-adjusted weight. Meaning, if the COA says 99.4%, we calculate the actual API mass accordingly before brewing to ensure it’s as close to 1:1 as possible.

Then when we send finished batches for HPLC, that gives us a real-world reflection of what’s in the vial (typically within 1–2% of target dosing) if not spot on.

So in short. COA tells us what’s going in -> HPLC tells us what came out. And if those numbers are lining up, we’re doing it right.
 
So the COA gives us the raw material purity (99.4%) before it’s ever touched a beaker. What we measure on our end (once brewed) is based on finished product concentrations, usually confirmed through HPLC or mass spec, depending on the lab and batch.

If you’re asking how our measured amounts compare: everything is dosed to label based on the raw’s assay-adjusted weight. Meaning, if the COA says 99.4%, we calculate the actual API mass accordingly before brewing to ensure it’s as close to 1:1 as possible.

Then when we send finished batches for HPLC, that gives us a real-world reflection of what’s in the vial (typically within 1–2% of target dosing) if not spot on.

So in short. COA tells us what’s going in -> HPLC tells us what came out. And if those numbers are lining up, we’re doing it right.
So you assumed 99.4% purity for the recipe and your HPLC results gave you what for the batch? I see some of your Test Cyp results are over target concentration and some lower. Obviously the inferred estimate from your batch results wraps all procedural error into the inferred raw purity.

Thanks for the discussion. Appreciate it.
 
I've been in your shoes, sort of. I've presented some product to the executive suite and said it provides, let's say, "real-time data analytics". And what I meant, and more importantly what I knew the buying decision-makers would interpret it to mean, is "interactive analytics that run fast enough to make you happy."

That's when some pedantic motherfucker from the engineering team, for whom I have an entirely different presentation that doesn't (mis)use a term of art like that, pops up and says "oh really? Your platform provides guaranteed bounded latency for arbitrary analytical queries?" with a scoff and a tip of the fedora. And then I've got to walk it back and explain what colloquial meaning we're using, and what our actual guarantees and latencies are, and of course more complex queries take more time, blah blah blah. It's annoying, but if we can't answer that guy, then he'll keep chipping away at our credibility and reputation within the company and we'll never get the sale, because in his mind, if we're wrong about something as basic as that, nothing we say is trustworthy.

He will do that even if he's used the product and found it satisfactory. That's not good enough. Somebody is wrong on the Internet.

Now you've got a pedantic motherfucker popping up and calling you out on some claims that most of us just ignored or interpreted in some way that made more sense. Maybe some of the duller knives in the drawer believed you literally, I don't know, but I doubt many did. So maybe "Pharma grade flow hood" really means "I bought a flow hood from a legitimate medical/lab equipment supplier and its specs are pretty good and we didn't just knock something together out of plywood", and maybe "pharma quality APIs" means "tests at 99% or greater purity". If you really are better than the next guy, that's enough to win all the business you want. Just tell us what you really meant and then back it up.

We don't really know what you mean, though, unless you tell us, and we don't know if we can trust those claims unless you provide evidence. Maybe there's a huge surprise here and you really do comply with a bunch of pharma manufacturing standards. There's not much point in doing that, though, unless you get some credit for it. Showing evidence would get you some credit.

But literally nobody expects that to be the case. If you responded to @readalot and said "we kind of misspoke on 'pharma grade' and actually should have said 'blah', which we think is quite good compared to others and entirely sufficient for this application", what most of us would hear is the good stuff. We're not going to clutch our pearls because you clarified that a statement we never believed or gave you any credit for in the first place isn't true.

Please help put this debate to rest and take your thread back. Just answer the damn questions.
Wow. Excellent.
 
For the reader's reference. Pretty good accuracy and variance.
Yep, we assumed 99.4% purity from the COA when weighing out the batch. The HPLC results you’re seeing, slightly over or under target, are a reflection of that assumed purity plus the normal procedural variables that come with brewing.

It’s never going to be 100% perfect every time, but we’re always aiming to tighten that margin. That’s exactly why we keep testing consistently, not just once and done.

And honestly I’ll admit, I brushed your earlier comments off thinking you were just being difficult. That’s on me. You’re actually asking solid questions and pushing the convo in a productive direction, so respect for that. Glad we got to actually engage.
 
Tried Tren once and bro, it turned me into a full-blown telenovela character. I was out with my girl, she made a tiny joke like, “You always flex in the mirror,” and suddenly I’m clutching my imaginary pearls, whispering, “How dare you…” Then I stormed off into the night like some tragic hero.

Even my cat wasn’t safe - he meowed the wrong way, and I straight-up told him, “Show some respect in my house.” That was just 500mg of Tren E. After that, I knew - I’m not built for this life.
 
Yep, we assumed 99.4% purity from the COA when weighing out the batch. The HPLC results you’re seeing, slightly over or under target, are a reflection of that assumed purity plus the normal procedural variables that come with brewing.

It’s never going to be 100% perfect every time, but we’re always aiming to tighten that margin. That’s exactly why we keep testing consistently, not just once and done.

And honestly I’ll admit, I brushed your earlier comments off thinking you were just being difficult. That’s on me. You’re actually asking solid questions and pushing the convo in a productive direction, so respect for that. Glad we got to actually engage.
Wait a damn minute. So your telling me everyone asking questions, isn't just questioning your legitimacy? Simply just engaging conversation about your process to ensure the claimed legitimacy?
 
Wow. Excellent.
Hey, man, I really appreciate that. And your commitment to harm reduction and getting us all the best info so we can make informed decisions.

Unfortunately, it may be the case that @Primal_Pharma can't hear your message over the sound of all the $44 (alleged) Masteron flying out the door. In which case the barrier you're banging into isn't a problem with the source. It's a problem with the customers you're trying to help. There just may not be a sufficient market for answers to these questions.

What a fucking amazing source Primal would be, though, if they had the things we can see -- competitive prices, responsive customer service, fast turnaround -- *and* demonstrably pure, clean, consistently dosed gear and high transparency. That would be a world-class, GOAT level source.
 
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