TrustPointe Analytics 🥼

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TrustPointe Analytics 🥼

TrustPointe Analytics 🥼

@TrustPointe

Lab Testing following US FDA Requirements for Potency & Purity of Consumer Injectables • Accuracy Matters. Results You Can Trust.

Dorr, MI انضم Kasım 2024
60 يتبع507 المتابعون
TrustPointe Analytics 🥼
TrustPointe Analytics 🥼@TrustPointe·
Day 3 of waiting for another lab to post their tirz method validation results
TrustPointe Analytics 🥼@TrustPointe

Since I harp on method validation, I’ll post receipts. USP <1225> method validation results for our very first method, TM-1001 Validated Range: 75ppm to 250ppm Linearity r-squared 1.000 @ 75ppm Accuracy 99.5% Precision 0.7% RSD @ 100ppm Accuracy 99.0% Precision 0.4% RSD @ 125ppm Accuracy 98.8% Precision 0.2% RSD @ 200ppm Accuracy 100.3% Precision 0.3% RSD @ 250ppm Accuracy 100.5% Precision 0.7% RSD If you are a lab running validated methods, post your receipts below 👇🏻

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TrustPointe Analytics 🥼
TrustPointe Analytics 🥼@TrustPointe·
@Alexfreiberger We are an Agilent house, so we are using Agilent stacks and Openlab CDS. We have an Agilent Crosslab contract for maintenance, and we qualify our systems (wavelength accuracy, flow rate accuracy/precision, gradient, injection, etc) annually or when there is a significant repair
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Alex Freiberger
Alex Freiberger@Alexfreiberger·
@TrustPointe What instrumentation and software are you utilizing? Are they qualified systems?
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TrustPointe Analytics 🥼
TrustPointe Analytics 🥼@TrustPointe·
We now have validated HPLC methods for GHK-CU, GLOW, KPV, and KLOW 👍🏻🥼👩🏼‍🔬
TrustPointe Analytics 🥼 tweet media
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TrustPointe Analytics 🥼 أُعيد تغريده
Peptide Partners
Peptide Partners@PeptidePartners·
boss man gave me full control of this account finally, youve been warned.
GIF
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TrustPointe Analytics 🥼
TrustPointe Analytics 🥼@TrustPointe·
@rorynotsorry 💯 We started TrustPointe because we saw what was available, and with our background in pharma QC knew we could improve transparency and harm reduction in the space Keep doing what you’re doing; you’re a catalyst for change!
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Rory Not Sorry
Rory Not Sorry@rorynotsorry·
I know I’m on the right side of Peptide Twitter, when I have analytical laboratories and other organizations debating detailed aspects of testing in my comments and feed. There is this assumption that everyone in the Gray world is dodgy or out to make a dollar. There is a surprising subset of people that actually deeply care about quality.
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Kimera Chems
Kimera Chems@KimeraChems·
@TrustPointe We have SOPs in place. Every step is documented from the time it's ordered to the time it's put in stock. We keep this documented so if there's issues between our manufacturer to our own internal team we know where to find an issue.
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TrustPointe Analytics 🥼
TrustPointe Analytics 🥼@TrustPointe·
I also think that businesses that make having a quality system part of their strategic roadmap moves them closer than their competitors to stepping out of the grey and into the regulated market
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TrustPointe Analytics 🥼
TrustPointe Analytics 🥼@TrustPointe·
As the low control market becomes more “commoditized” and prices race to the bottom, one way business have an opportunity to differentiate themselves is by advancing their critical quality processes: Formulation Studies (AET, etc) Stability Studies & Expiration Dating Supplier Controls Change Control Document Control Identification and Traceability (real traceable lot numbers Process Validation Etc etc
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TrustPointe Analytics 🥼
TrustPointe Analytics 🥼@TrustPointe·
Don’t get me wrong: every improvement is a step in the right direction. And accessibility may trump quality concerns. But there is a long, long, … long road ahead for this space to mature to the same quality level as a bottle of ibuprofen you buy off the shelf at Walmart
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TrustPointe Analytics 🥼
TrustPointe Analytics 🥼@TrustPointe·
It will. There’s a constant pipeline of new consumer injectables from drug companies, research papers, and even drug candidates that didn’t complete clinical trials endpoints but still demonstrate efficacy for some people. For the first time, people are empowered to make their own health decisions, and the market moves faster than gov ever can or will.
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Rory Not Sorry
Rory Not Sorry@rorynotsorry·
I love this change by Finnrick. I actually built most of my following and social media a year ago based on calling out companies for not doing batch IDs. Hopefully this drives the overseas vendors to start doing it more.
finnrick@finnrick_tests

Batch IDs are now required for free tests, with photo evidence. This is good for the testing data (whatever you purchased can’t really be compared with results with no batch ID). Here’s what a batch ID looks like: help.finnrick.com/what-counts-as…

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TrustPointe Analytics 🥼
TrustPointe Analytics 🥼@TrustPointe·
@rorynotsorry This is like Purity where I had to go around and burst everyone’s false sense of security bubble on what it actually means 🤣 (sorry, but scientific rigor and quality control is my passion)
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TrustPointe Analytics 🥼
TrustPointe Analytics 🥼@TrustPointe·
Batch numbers are only as good as the lot identification and traceability controls behind them, and trust me, they aren’t there. In an ideal state, a single lot number would trace back to one vial batch and one mixing batch. If anything was wrong, you could recall the one lot and get all the bad product. In general (sure there are exceptions), this level of control doesn’t exist in this market, so shipments of 20mg tirz are mixed vials from multiple production lots, rendering lot numbering after meaningless. Based on the report from @QualseraMark, we have a hard enough time knowing what is in the vial (identification) 🤣
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TrustPointe Analytics 🥼
TrustPointe Analytics 🥼@TrustPointe·
Will be interesting to see what happens as the licensed compounders (503A and 503B) start up. Still heavily regulated, with strict limitations on quantities, but state enforcement is lax. Michigan outsources pharmacy inspections to NABP and doesn’t follow up on findings .
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TrustPointe Analytics 🥼
TrustPointe Analytics 🥼@TrustPointe·
Day 2 of waiting for any other lab in the space to post their HPLC assay method validation
TrustPointe Analytics 🥼@TrustPointe

Since I harp on method validation, I’ll post receipts. USP <1225> method validation results for our very first method, TM-1001 Validated Range: 75ppm to 250ppm Linearity r-squared 1.000 @ 75ppm Accuracy 99.5% Precision 0.7% RSD @ 100ppm Accuracy 99.0% Precision 0.4% RSD @ 125ppm Accuracy 98.8% Precision 0.2% RSD @ 200ppm Accuracy 100.3% Precision 0.3% RSD @ 250ppm Accuracy 100.5% Precision 0.7% RSD If you are a lab running validated methods, post your receipts below 👇🏻

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@Alexfreiberger @fsasjohn @PeptidePartners @ZakDavid @rorynotsorry @elonmusk @BarackObama @taylorswift13