Source QC and C of A (do you have one?)

[readalot]

Determination of Impurities in Pharmaceuticals: Why and How?

The presence of impurities, particularly the API-related impurities, i.e., degradation-related impurities (DRIs) and interaction-related impurities (IRIs), may affect the quality, safety, and efficacy of drug products. Since the regulatory requirements and management strategies are required to...

www.intechopen.com

https://www.agilent.com/cs/library/primers/Public/5991-1876EN.pdf

https://journals.sagepub.com/doi/full/10.1177/1091581820946746

 

[readalot]

Patience my friend. We are doing a trial run of this type of test with one of our raw powders. Stay tuned. Results will be shared.

Results also take 3-4 weeks on this test as per Jano.

Any update @Axle Labs? What did you test?

If you or @Stanfordpharma1 ever get anything you'd love to share please let me know.

Thank you.

 

[readalot]

Good paper detailing structural impurities in the testosterone synthesis step.

Identification and Structural Elucidation of New Process Impurity in Testosterone

Abstract. The main objective of this study is identification, isolation and characterization of potential impurity of testosterone. Testosterone was analyz

academic.oup.com

You'll see a couple of these were present (very small amounts) in the Pharma product C of A I posted above.

So before someone PMs me again stating the only potential impurities/contaminates in gear are heavy metal impurities, I'll summarize the list:

1. Structural impurities from either API synthesis or coming along with the esterication step (no real health concern above that of AAS API)

2. Heavy metals/elemental impurities

3. Residual solvents (solvents used in synthesis and purification of AAS)

4. Excipents used in formulation and any degradation products (BA, BB. Note degradation products of BB are BA and benzoic acid formed via hydrolysis with residual moisture). Benzaldehyde potentially another impurity from BB.

5. Carrier oil and quality

All these would make it through sterile filtration step.

6. Bacteria/mold/endotoxins (removed with proper sterile filtration)

7. Visible (floaters) / subvisible particulates. Visible particulates would be manufacture error.

Did I miss any?

 

[Sector]

Looks like I have a lot to read up on, but this was a good starter read.

I think this kind of testing is critical, not only with regard to harm reduction, but also taking gear quality to the next level.

Appreciate your work. Keep fighting the good fight

 

[readalot]

Looks like I have a lot to read up on, but this was a good starter read.

I think this kind of testing is critical, not only with regard to harm reduction, but also taking gear quality to the next level.

Appreciate your work. Keep fighting the good fight

Thank you @Sector . Welcome to the "nobody cares" club. I hope we don't get too large a membership. That would be a lot of nobodies.

The time is coming. I appreciate you taking the time to share your thoughts. I really do.

 

[Sector]

Thank you @Sector . Welcome to the "nobody cares" club. I hope we don't get too large a membership. That would be a lot of nobodies.

The time is coming. I appreciate you taking the time to share your thoughts. I really do.

I'm only on page 5 currently, but I love how the first 5 pages are you getting roasted for suggesting sources do impurity analysis. God forbid someone tries to increase the standard/quality of gear...

I do also see/agree with some of the points that millard has brought up so far from a practicality standpoint in that demanding both quantitative + qualitative analysis of gear as a minimum requirement for being listed as a source could be a bit of a large ask for every UGL, and that it's mostly at the customer's discretion of what standards they're willing to accept.

A lot of customer demand boils down to market segment. At the lower end of the segment, you have customers that will buy the cheapest gear they can find, and don't care about impurity testing and probably don't do quantitative testing of any kind, relying mostly on "feels" and price point to determine what they're going to buy, or who they're going to buy from. On the opposite end of the segment, you have the people that will shell out large quantities of money for pharmacy grade HGH and gear simply for peace of mind and knowing they're getting the highest quality/most accurately dosed products available. There's also a market segment somewhere in the middle, of consumer's that use UGL gear, but still want high quality/accurately dosed gear thats been rigirously tested and with safety standards as close to pharmacy grade gear as possible, and who are willing to pay a premium for these kinds of products, and I think this is the market segment your post appeals to the most. I also think that from a harm reduction perspective, it makes sense to do as much testing as possible, and to refine the products/processes to a nearly scientific level, even if deemed impractical by the current set of blackmarket/UGL standards.

If there's three sources, and
- Source A does no testing at all
- Source B does quantitative testing to make sure that their gear is properly dosed
- Source C also does quantitative testing, but also tests for impurities, along with other qualitative analysis, but as a result of the additional testing charges $5 more per vial

I'd like to think that most people would go with Source C, and that source C would have a competitive advantage over the other two sources, and better long-term business overall. I wouldn't be suprised if the standards you're proposing becomes a thing within the next 5 years, as technology and research continues to expand

 

[AlexDavis43]

If there's three sources, and
- Source A does no testing at all
- Source B does quantitative testing to make sure that their gear is properly dosed
- Source C also does quantitative testing, but also tests for impurities, along with other qualitative analysis, but as a result of the additional testing charges $5 more per vial

1) Buy from source A and send samples for any fancy testing you'd like.

Customer blind tests are more reliable than trusting what the source sends in for testing is the same product they sell you anyway.

...but I think the whole point is trying to get someone else to pay for it. Who knows, maybe some vendors will reimburse for this level of analysis.

2) Source B: vendor testing is better than no testing if you're not willing or able to do it yourself.

3) Source C: that's +$50 per kit for something that's probably nothing.

 

[Sector]

1) Buy from source A and send samples for any fancy testing you'd like.

Customer blind tests are more reliable than trusting what the source sends in for testing is the same product they sell you anyway.

...but I think the whole point is trying to get someone else to pay for it. Who knows, maybe some vendors will reimburse for this level of analysis.

2) Source B: vendor testing is better than no testing if you're not willing or able to do it yourself.

3) Source C: that's +$50 per kit for something that's probably nothing.

Blind tests are more reliable so in this hypothetical example, why not just skip the BS with sources A and B and just blind test Source C, which has already been quantitatively and qualitatively evaluated by the source, but now also independently tested by the customer? Would make more sense.

If you blind test source A in this example, you'd have nothing to benchmark the blind test against, as source A isn't testing their gear in this hypothetical example.

In a perfect scenario you would want the source testing their gear, you'd want the customer blind testing the gear, and you would want the blind tests to be confirmed by multiple independent laboratories running the same tests (say there was multiple jano type laboratories capable of performing these tests). If everyone's tests arrive at the same conclusion, then that would be best case scenerio. If there are discrepancies, then you'd obviously have to figure out why, and there would be a lot of variables to work through

 

[readalot]

...but I think the whole point is trying to get someone else to pay for it.

that's +$50 per kit for something that's probably nothing.

The age old question....who should pay?

You sound pretty confident. What data helped you reach that conclusion? Kit? Thats quite interesting what you did there.

Let's start with AAS, how's that?

I've done many posts above sharing an incredible amount of info why this testing is important and needed. The risk of impurity contamination with AAS will always be present (by the nature of the processes used to synthesize and purify them).

I applaud @Axle Labs for being the first subscriber to take a first step with the upcoming ICP test with @janoshik . The other piece that needs more work is identifying a reputable analytical lab that can handle the residual solvents question.

 

[RaddishPork]

Great in theory. I personally would like to avoid unnecessary carcinogens or metals going into my body. Only problem with that is I’m probably getting it more from my everyday life than i am from gear. Even vaccines for infants and toddlers have metals in them that have been deemed neurotoxic.

This would be a great option for the extra health-conscious folks and those sources would probably make even more profit (although it’d take extra work).

But at the end of the day I really don’t see the healthy (metaphorically) “no -GMO organic” labs overtaking everyone else to make this the new standard. Whole foods is an awesome store that I go to sometimes when I really want to pick my food carefully, but I’ll always go to Walmart and Kroger for the basics.

It’s a cool idea, but it’s banking on 2 things that aren’t practical
1- The sources caring about the consumers long term health more than their own profits.
2- Us consumers caring about our own health more than our desires / checking account.

Unless I can see metrics showing a huge difference in contaminants, I couldn’t justify upping my steroid budget hundreds - thousands of dollars a year. Don’t forget a huge chunk of our demographic are the guys in the mid 20s to mid 30s who haven’t got that career job yet. And sometimes the $100 difference really does matter. I’m also broke as shit right now because I just changed jobs. I’ll probably view this much differently once I get my income rolling in again.

 

[readalot]

Thanks for your feedback. Those metrics are kind of tricky...you gotta get them first so you can run your personal cost/benefit (risk reduction) calculus. And of course the last batch is only as good as its testing. Nevertheless, a survey of gear inpurities for even a few months would be useful and educational for the consumer to see what's out there. And of course the manufacturers would up their game further once that know they are being watched.

I couldn’t justify upping my steroid budget hundreds - thousands of dollars a year

could not help but run the math at the midpoint....

1000 USD per year divided by (extra 5 USD per 10 ml vial/ 100 count bottle)

That's a lot of gear!

200 vials per year (10 ml) divided by 50 weeks (2 week vacation haha) = 4 vials per week

Let's say that is 250 mg/ml in each vial:

4 vials/week x 10 ml/vial × 250 mg/ml = 10,000 mg/week AAS (10 g/week)

You aren't messing around.

Best wishes on the new job.

 

[RaddishPork]

I do not believe you can apply Hawthorne to this scenario. For a few reasons.

1) These are not plant workers being watched over for their productivity.
2) This is an illegal business. Morals and standards are a bit different. Anonymous Drug dealers don’t care who is watching them as long as it’s not the law.
3) Even the link you shared mentions it being a questionable theory that maybe only yielded *temporary* results.

There is such thing as companies or industries becoming too big to fail. How much scrutiny have Walmart, McDonald’s, and Amazon gone under? Yet they’re still consistently some of the most profitable and successful entities on earth. Your Amazon driver is still a single mom getting paid 1/3rd a living wage, and your McNuggets still come from a pink paste. These Chinese labs selling for $9 a vial have the leverage here.

Not sure if you think you’re a wise guy or trying to be facetious on that last part, but you quoted the high end of my numbers for your math project to exaggerate the outcomes. However, If you’re trying to imply that people don’t spend hundreds or thousands of dollars a year on gear, you’re out of your mind. Not to mention the different concentrations, esters, and costs of different compounds. This idea of yours would include oils, orals, GH, and all the new peptides flooding the market. Or do you only care about quality of anabolic oils? Whether it be for resell, personal use, or a combination of those purposes, people spend a lot of money on this stuff. Saying $5 a vial is probably a lowball estimate, and it’s going to apply to every single item on an order. Don’t forget how capitalism works. Once this new testing is in high demand, it’s going to get real expensive. Lastly, everyone is already used to the current standard, so you’re fighting an uphill battle by saying “hey guys I know this thing isn’t broken but I found a way to fix it for more money and effort!”

If you guys come up with the vegan, non GMO, metal-free, organic steroids I’ll give them a try. Not sure if it’s passion, stubbornness, or a savior complex, but this is a lot of energy put into something that multiple people have told you they don’t care about. Reading through this thread it sounds like you believe you’re onto a groundbreaking discovery and everyone else is silly for not praising you. Just remember, if you think everyone in the room is a jackass except for you, then you’re most likely the jackass in the room.

 

[FastBunny]

I do not believe you can apply Hawthorne to this scenario. For a few reasons.

1) These are not plant workers being watched over for their productivity.
2) This is an illegal business. Morals and standards are a bit different. Anonymous Drug dealers don’t care who is watching them as long as it’s not the law.
3) Even the link you shared mentions it being a questionable theory that maybe only yielded *temporary* results.

There is such thing as companies or industries becoming too big to fail. How much scrutiny have Walmart, McDonald’s, and Amazon gone under? Yet they’re still consistently some of the most profitable and successful entities on earth. Your Amazon driver is still a single mom getting paid 1/3rd a living wage, and your McNuggets still come from a pink paste. These Chinese labs selling for $9 a vial have the leverage here.

Not sure if you think you’re a wise guy or trying to be facetious on that last part, but you quoted the high end of my numbers for your math project to exaggerate the outcomes. However, If you’re trying to imply that people don’t spend hundreds or thousands of dollars a year on gear, you’re out of your mind. Not to mention the different concentrations, esters, and costs of different compounds. This idea of yours would include oils, orals, GH, and all the new peptides flooding the market. Or do you only care about quality of anabolic oils? Whether it be for resell, personal use, or a combination of those purposes, people spend a lot of money on this stuff. Saying $5 a vial is probably a lowball estimate, and it’s going to apply to every single item on an order. Don’t forget how capitalism works. Once this new testing is in high demand, it’s going to get real expensive. Lastly, everyone is already used to the current standard, so you’re fighting an uphill battle by saying “hey guys I know this thing isn’t broken but I found a way to fix it for more money and effort!”

If you guys come up with the vegan, non GMO, metal-free, organic steroids I’ll give them a try. Not sure if it’s passion, stubbornness, or a savior complex, but this is a lot of energy put into something that multiple people have told you they don’t care about. Reading through this thread it sounds like you believe you’re onto a groundbreaking discovery and everyone else is silly for not praising you. Just remember, if you think everyone in the room is a jackass except for you, then you’re most likely the jackass in the room.

If there was a hall of fame thread for replies, this should be one of the first ones on there. The threads I have read from him are stupidity and beyond. Coffee, tea, have heavy metals. He must think these guys supplying gear work as sub contractors for Pfizer.

 

[Obscured78]

If there was a hall of fame thread for replies, this should be one of the first ones on there. The threads I have read from him are stupidity and beyond. Coffee, tea, have heavy metals. He must think these guys supplying gear work as sub contractors for Pfizer.

It’s Travis Kelse

 

[readalot]

I do not believe you can apply Hawthorne to this scenario. For a few reasons.

1) These are not plant workers being watched over for their productivity.
2) This is an illegal business. Morals and standards are a bit different. Anonymous Drug dealers don’t care who is watching them as long as it’s not the law.
3) Even the link you shared mentions it being a questionable theory that maybe only yielded *temporary* results.

There is such thing as companies or industries becoming too big to fail. How much scrutiny have Walmart, McDonald’s, and Amazon gone under? Yet they’re still consistently some of the most profitable and successful entities on earth. Your Amazon driver is still a single mom getting paid 1/3rd a living wage, and your McNuggets still come from a pink paste. These Chinese labs selling for $9 a vial have the leverage here.

Not sure if you think you’re a wise guy or trying to be facetious on that last part, but you quoted the high end of my numbers for your math project to exaggerate the outcomes. However, If you’re trying to imply that people don’t spend hundreds or thousands of dollars a year on gear, you’re out of your mind. Not to mention the different concentrations, esters, and costs of different compounds. This idea of yours would include oils, orals, GH, and all the new peptides flooding the market. Or do you only care about quality of anabolic oils? Whether it be for resell, personal use, or a combination of those purposes, people spend a lot of money on this stuff. Saying $5 a vial is probably a lowball estimate, and it’s going to apply to every single item on an order. Don’t forget how capitalism works. Once this new testing is in high demand, it’s going to get real expensive. Lastly, everyone is already used to the current standard, so you’re fighting an uphill battle by saying “hey guys I know this thing isn’t broken but I found a way to fix it for more money and effort!”

If you guys come up with the vegan, non GMO, metal-free, organic steroids I’ll give them a try. Not sure if it’s passion, stubbornness, or a savior complex, but this is a lot of energy put into something that multiple people have told you they don’t care about. Reading through this thread it sounds like you believe you’re onto a groundbreaking discovery and everyone else is silly for not praising you. Just remember, if you think everyone in the room is a jackass except for you, then you’re most likely the jackass in the room.

Hey, first thanks for your well written and conscientious reply.

I took the mid point and applied it to an injectable AAS scenario for brevity. Was not trying to exaggerate your position. Currently my best estimate is an extra 3 to 5 USD per bottle/vial. And yes, the scope of all the above work was injectable and oral AAS in terms of impurity analyses. Obviously adding peptides, GH, etc will add additional work / details. I was starting relatively simple with limited scope.

So my interest in all this really was to see what was out there in terms of impurity load in UGL gear. There's nothing groundbreaking here; all this is tested every day in the pharmaceutical industry. I don't give a darn about any praise.
Anyway, thanks for chiming in and did not intend to get sideways with you. I don't think everyone in the room is a jackass and your practical points are well taken. I've got no financial incentive in this just trying to raise the bar. To your point some/most may be quite happy with current bar height. Still don't know if there is an issue or not.

That's why you form a hypothesis and then collect data..

Take care.

 

[readalot]

The threads I have read from him are stupidity and beyond.

How so?

Curious. Stupidity? Hmmm.

 

[readalot]

Coffee, tea, have heavy metals

What is your point? Surely you understand the dose makes the poison? Take the applesauce issue in US here recently. Or the tuna thread I did. Not following you.

What is your thesis? Don't measure it (residual solvents, metals, structural impurities) cause we don't care.

Love to hear your perspective.

 

[FastBunny]

What is your point? Surely you understand the dose makes the poison? Take the applesauce issue in US here recently. Or the tuna thread I did. Not following you.

What is your thesis? Don't measure it (residual solvents, metals, structural impurities) cause we don't care.

Love to hear your perspective.

Figures why the majority of yours replies are blown off. You are equally as incompetent as your copy and paste post. I do agree with you, in regards to the harmful toxins, heavy metals. Perhaps, that’s been the cause of your degrading brain cells at such an exponential rate leading to your moronic post. Your facts are as insignificant as your research post. It’s comforting to see you are filling a void of a never achieved Ph.D. Maybe you’ll get a Meso Certified one in bro science! Best of luck in your heavy metal researching! Perhaps it’ll be published on Mayo Clinic sometime soon !

 

[readalot]

Figures why the majority of yours replies are blown off. You are equally as incompetent as your copy and paste post. I do agree with you, in regards to the harmful toxins, heavy metals. Perhaps, that’s been the cause of your degrading brain cells at such an exponential rate leading to your moronic post. Your facts are as insignificant as your research post. It’s comforting to see you are filling a void of a never achieved Ph.D. Maybe you’ll get a Meso Certified one in bro science! Best of luck in your heavy metal researching! Perhaps it’ll be published on Mayo Clinic sometime soon !

Thanks. Very insightful. You sound angry.

I like the assumption you placed in there.

Your post is fascinating. Really.

 

[readalot]

So how about either put up or shut the fuck up?

Makes sense now.