51 replies to this topic

[zencatholic]

Thought everyone might be interested.

Peace be with you all,
AMDG

Zen Catholic

[LifeMirage]

PYRIDOXAMINE-2HCl is one of three natural forms of vitamin B6. Unlike the oter two forms, it has been shown to counter the negative effects of blood sugar by inhibiting glycation and the formation of AGEs in ways similar to carnosine and benfotiamine. Pyridoxamine is neuroprotective, and inhibits lipid peroxidation and vascular damage, making it a premier anti-aging substance. It reduces oxidative stress by blocking superoxide radicals. In Europe it has been used to treat diabetic complications in animals and humans, and studies have compared it to the drug aminoguanidine. Usual dose is up to 100mg, 2 x per day. Elsewhere, 6 grams in capsules is listed at $25 or more. PYRIDOXAMINE-2HCl, pure powder, 20g (200 dose) (SRP $25.00), Our Price: $12.50. Code 106.8

Great news!!

[nootropi]

PYRIDOXAMINE-2HCl is one of three natural forms of vitamin B6. Unlike the oter two forms, it has been shown to counter the negative effects of blood sugar by inhibiting glycation and the formation of AGEs in ways similar to carnosine and benfotiamine. Pyridoxamine is neuroprotective, and inhibits lipid peroxidation and vascular damage, making it a premier anti-aging substance. It reduces oxidative stress by blocking superoxide radicals. In Europe it has been used to treat diabetic complications in animals and humans, and studies have compared it to the drug aminoguanidine. Usual dose is up to 100mg, 2 x per day. Elsewhere, 6 grams in capsules is listed at $25 or more. PYRIDOXAMINE-2HCl, pure powder, 20g (200 dose) (SRP $25.00), Our Price: $12.50. Code 106.8

Great news!!

Provide a link, at least? [glasses]

[LifeMirage]

http://www.beyond-a-century.com/

[nootropi]

http://www.beyond-a-century.com/

Thanks!

[fieyaa]

great price too.. wow!

[nootropi]

great price too.. wow!

I just placed an order for several items...I am always excited about adding new beneficial supplements to my life!

[jvalentin]

BAC doesn't ship to Europe. What's the less expensive provider for international orders ?

[LifeMirage]

Smart Nutrition

[AORsupport]

Do any of these companies have HPLC analyses of the purity of their pyridoxamine raw material and/or finished products?

AOR has been excited about the research on pyridoxamine for years now, and for the last four years has been tracking down and negotiating with various labs, and testing their samples, with the intent of introducing a pharmaceutical-grade pyridoxamine supplement. There have been many setbacks in this process. For the first 2-3 years, the main problem was that the quotes we were receiving would have made the final product commercially unviable. But for the last year or so, we have been receiving much more reasonable quotes, and assurances of quality. Optimistically, we have requested samples, specification sheets, and certificates of analysis, all of which have been duly sent. But when we have sent these samples to independent labs to be checked, each and every one has flunked. It appears that the reason for these discrepancies is not simple supplier dishonesty or incompetence in their testing labs. It is a problem of outdated testing methodology.

The industry standard methods for testing pyridoxamine are last-generation tests such as melting point, optical rotation, anch chemical titration tests. Such tests are in fact still listed in the USP -- in large part, we believe, because PM is not in widespread human use and indeed is largely only available in reagent grade. By contrast, AOR insists on HPLC testing. The old-style tests being used by the would-be suppliers report >98% PM for their materials, but the HPLC performed for AOR by independent labs have reported from 89% to 95% PM for various samples. The difference between the two tests' results is accounted for by a second HPLC peak, which is as yet unidentified but which appears to be a degradation product of PM.

Apparently, whatever this contaminant may be, its structure is close enough to PM itself to pass for PM on the old-style test. This makes some sense: the contaminant's HPLC peak is very close to that of PM itself, and the unknown substance likely shares a lot of PM's basic chemistry. As a result, if companies rely on the old-style method of testing, they will get a favorable result even if a significant amount of the material is in fact not PM, but this contaminant -- a likely degradation product, whose identity and biological impact are unknown.

I am aware that for some time some life extensionists have been using reagent-grade PM purchased from chemical supply houses, which is itself risky for long-term use in and of itself due to the likely presence of trace heavy metals, solvents, and other trace impurities. But it appears that even allegedly pharma-grade "pyridoxamine" is contaminated with surprisingly high amounts of some unknown impurity.

AOR will continue to work with existing and new potential suppliers toward the development of a true, pharmaceutical-grade PM supplement. In the mean time, unless a company can provide an HPLC assay from a reputable independent laboratory demonstrating that its raw material and/or pills are >98% pure pyridoxamine , I strongly counsel against the use of any existing PM supplements.

To your health!

AOR

[zencatholic]

AOR-

Assuming your statistics are true, isn't 89-95% PM better than no PM at all? In addition, most of us probably take sufficient supplements and have diets designed to counteract any trace heavy metals or other impurities. For example, I take supplements such as chlorella, milk thistle and NAC regularly, and try to juice green vegetables (including cilantro, another detoxifier) daily. I porbably take 6-12 supplements which have some sort of detoxifying action to them.

You position seems to be the same as the LEF philosophy - that if a product is not pharmaceutical grade, then it's not doing you much (or any) good. Most of us can't afford pharmaceutical-grade supplements.

Given my financial limitations, why should I not take a product which is 89-95%PM? Is that 89-95%PM somehow inferior? If it is, why is not worth taking?

Thanks for your thoughts.

Peace be with you,
AMDG

Zen Catholic

[AORsupport]

AOR-

Assuming your statistics are true, isn't 89-95% PM better than no PM at all? ...

Given my financial limitations, why should I not take a product which is 89-95%PM?  Is that 89-95%PM somehow inferior?  If it is, why is not worth taking?

By definition, there is nothing wrong with the 89-95% of this material which genuinely is PM. The issue is: what is the biological impact of consuming the contaminant? The answer, at present, is that we haven't the foggiest idea. It could be harmless -- or it could be a quite nasty, slow-acting toxin whose long-term effects will never be discovered because so few people on a population basis are consuming it (as opposed to widely-used vitamin C or alpha-tocopherol supplements). Not to get too melodramatic, but I can see people gathering 'round the careless life extensionist's coffin, saying "I can't understand it: with all of the pills s/he swallowed ..."

The fact that most of this material is pyridoxamine doesn't mean that the remainder is harmless, or a fair tradeoff. The overwhelming majority of the material in chewing tobacco is harmless protein, carbohydrate, fiber, and fat -- and it even contains vitamins, minerals, and phytochemicals! Still, one shouldn't therefore think of a daily chaw as an extra serving of vegetables . More than a truly tiny amount of an unknown contaminant is simply not an acceptable risk for a person looking forward to the dawn of radical life-extension medicine.

It would be one thing to take such a risk if you were (for instance) at short-term risk of massive AGE-related pathology, such as diabetic complications; it is quite another when one is essentially healthy and thus has relatively little to gain, and much to gamble away. (If you think about it, in fact, pharmaceutical standards are set precisely for people who do have life-threatening illness, and the presence of more than trace amounts of contaminants are still not considered to be an acceptable tradeoff for a few dollars saved). There would be little more bitter than to spend years pursuing extended youth, health, and longevity, only to discover that one has actually been poisoning oneself with the very substances which one has been swallowing in hopes of extended lifespan.

You position seems to be the same as the LEF philosophy - that if a product is not pharmaceutical grade, then it's not doing you much (or any) good.  Most of us can't afford pharmaceutical-grade supplements.

I really doubt that this is true for many people. Pharmaceutical-grade supplements are usually more expensive than much of what's out there, true -- the difference is rarely so dramatic as to leave many people able to afford the one, but not the other.

To your health!

AOR

[zencatholic]

AOR

I understand your point, but with almost everything I ingest, whether fast food, food bought at the grocery store, or restaurant food, I am ingesting things which are "not on the menu" - pesticides, solvents, etc. Taking supplements with a small percentage of "unknown" constituents at first blush appears to be no better or worse than ingesting food at large.

Peace be with you,
AMDG

Zen Catholic

[nootropi]

Optimistically, we have requested samples, specification sheets, and certificates of analysis, all of which have been duly sent. But when we have sent these samples to independent labs to be checked, each and every one has flunked. It appears that the reason for these discrepancies  is not simple supplier dishonesty or incompetence in their testing labs. It is a problem of outdated testing methodology.

If it is indeed true that you have recieved

samples, specification sheets, and certificates of analysis

You make it sound as if these samples you recived were grossly unacceptable; I would expect that surely you documented these grossly unacceptable samples, correct? If you did not I would question the validity of your claims that you

sent these samples to independent labs to be checked

and that

each and every one has flunked

In accordance with your high standards, of course you kept records of these occurences, right? Show me, don't tell me.

[algernon]

If it's true that:
"By definition, there is nothing wrong with the 89-95% of this material which genuinely is PM. The issue is: what is the biological impact of consuming the contaminant? The answer, at present, is that we haven't the foggiest idea. It could be harmless -- or it could be a quite nasty,... "

then how is 98% pure any different? unless you know what the other 2% actually is, that too could be "quite nasty"

Something 100% pure can be helpful if you have problem to combat but counter-productive if you are healthy.
choose carefully....you are in charge of your own health...
(not to choose is also a choice)

Be Healthy

[ejdavis1]

I've worked in sales and marketing before and know that intangible qualities of a product or service can be the largest contributor to value. Consumers love having that safety margin built into products. A little over-insurance never hurt anyone if you can afford it. If it does not cost me that much more, I'll gladly go for the purer supplement.

I do, however, tend also to agree with Zen Catholic's insight above. Our food supply and breathing air almost certainly contain tiny amounts of "unknown contaminants." Is that unacceptable as well?

Edited by ejdavis1, 23 August 2004 - 06:04 AM.

[nootropi]

I've worked in sales and marketing before and know that intangible qualities of a product or service can be the largest contributor to value.  Consumers love having that safety margin built into products.  A little over-insurance never hurt anyone if you can afford it.  If it does not cost me that much more, I'll gladly go for the purer supplement. 

I do, however, tend also to agree with Zen Catholic's insight above.  Our food supply and breathing air almost certainly contain tiny amounts of "unknown contaminants."  Is that unacceptable as well?

Surely, I agree; however, wouldn't you be resentful towards a supplement provider if they rambled on and on (and on) about the inferiority of "other" providers' products, basing their argument on the premise that their products are superior due to their so called higher standards -- BUT -- when later asked to produce the documentation of their own quality control standards they could not bring anything to the table? (I am referring to AOR in this case; I asked AORsupport to present the members of this forum with the evidence and documentaion to support the claim that AOR indeed tested pyridoxamine samples at "independent" labs and found them to be inferior...and I am still waiting to see them...)

...I mean, this should be a chance for AORsupport to show off AOR's excellent quality control standards, right? Now, if AORsupport cannot produce any evidence (that AOR conducted tests of several samples of pyridoxamine, which, let me remind you: "flunked") then what can we conclude about AOR's products? [wis]

Edited by nootropi, 23 August 2004 - 01:17 PM.

[AORsupport]

Optimistically, we have requested samples, specification sheets, and certificates of analysis, all of which have been duly sent. But when we have sent these samples to independent labs to be checked, each and every one has flunked. It appears that the reason for these discrepancies  is not simple supplier dishonesty or incompetence in their testing labs. It is a problem of outdated testing methodology.

If it is indeed true that you have recieved "samples, specification sheets, and certificates of analysis"

You make it sound as if these samples you recived were grossly unacceptable; I would expect that surely you documented these grossly unacceptable samples, correct?

In accordance with your high standards, of course you kept records of these occurences, right?

Of course.

Show me, don't tell me.

See below for the quantitative results for the last three such instances. I have also included the HPLC of the latest of these for illustrative purposes.

Without naming specific vendors, we have reason to believe that the supplier for our sample lot #031005-5, analyzed 2004-02-13, is currently in wide commercial use.

If you did not I would question the validity of your claims that you "sent these samples to independent labs to be checked" and that "each and every one has flunked"

I trust that the converse is also true.

To your health!

AOR

Attached Files

•  allreports.jpg   161.28KB   0 downloads

[AORsupport]

 
If it's true that:
"By definition, there is nothing wrong with the 89-95% of this material which genuinely is PM. The issue is: what is the biological impact of consuming the contaminant? The answer, at present, is that we haven't the foggiest idea. It could be harmless -- or it could be a quite nasty,... "

then how is 98% pure any different? unless you know what the other 2% actually is, that too could be "quite nasty"

The cheeky answer is that there is a simple arithmetical difference between 98% and 89-95% -- but it's more complicated than that, of course. The standards for pharmaceutical quality take into account several things in setting reasonable tolerance levels. First is the fact that a material that is fundamentally clean may show less than 100% purity due to simple accumulation of water from the atmosphere. In some materials, taking up 1% water may be perfectly harmless, whereas in others it may lead to chemical degradation. This depends on the chemical properties of the material itself. There is also the matter of known contaminants, and of their safety or lack thereof: the more toxic known contaminants are -- or the less well-characterized those contaminants -- the less tolerance is deemed acceptable. There is also the matter of using an additional screen when materials initially appear clean, for heavy metals and/or solvents, which can be unacceptable in parts per million or parts per billion, depending on what they are. The standard must also take into account experimental error. And so forth.

More information on the development of internationally-accepted standards for quality in pharmaceutical ingredients is available from the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) website.

When a material thus meets the pharmaceutical standard (which for most materials is 98-102% purity, plus defined limits for certain specified contaminants), one can be confident that a given material is of high quality and contains little to nothing of concern. When it does not, it should be rejected. That's why these standards are established in the first place; all else is a slippery slope.

Something 100% pure can be helpful if you have problem to combat but counter-productive if you are healthy.
choose carefully....you are in charge of your own health...
(not to choose is also a choice)

Also, of course, true -- and important to bear in mind. And many substances which are promoted for their health benefits are, in fact, either certain or likely health threats (see previous posts on CLA and idebenone), or become such at high doses (preformed vitamin A, zinc, selenium, etc), even if they are exquisitely pure, because of their intrinsic properties.

Our food supply and breathing air almost certainly contain tiny amounts of "unknown contaminants." Is that unacceptable as well?

That depends on the compound. In 1974, 25% of an exposed population in India died after eating corn contaminated with aflatoxin levels ranging from 6250 to 15600 parts per million. And that's just acute toxicity: aflatoxin continues to be a major cause of liver cancer in much of the world at levels orders of magnitude lower than this -- it just takes a few decades to manifest itself.

On the other hand, you could quite happily eat food containing similar levels of some other contaminant -- as eg basically 'clean' dirt with a few common soil bacteria.

In any case, such materials ought to be very much "tiny amounts:" there is something very wrong with your spinach if it contains 5-10% by weight of some contaminant, as in the case of these pyridoxamine samples.

The governments of the world do, in fact, set standards on food contamination for just this reason, mostly for specified contaminants since there are many naturally-occurring contaminants which are essentially harmless and/or to which humans have evolved defenses over the course of millenia of regular exposure. Some of these standards are, however, quite rigorous. The US government's mandated maximum aflatoxin in corn is 20 parts per billion.

To your health!

AOR

[nootropi]

Well see, wasn't that nice? You got a chance to show off your standards. Your welcome!

The improvements AOR needs to make hereforward:

1) Lower the prices on the encapsulated products to reasonable prices, (or sell bulk powders, probably the easier solution).

The fact is, your profit on encapsulated products are absolutely ridiculous (trust me, I checked). Capsules cost you less than one half a cent; you get most powders for under 200 dollars per kilogram; etc. etc.
How can you consider AOR an asset to the life extensionist if, in order to have a full fledged anti-aging regimen we must go bankrupt?

You cannot keep a straight face and tell me that you are not charging more than you need to be for your products. In other words, you still could do a lot better for the life-extensionist.

Edited by nootropi, 19 December 2004 - 06:54 PM.

[ejdavis1]

I don't think that prices should be judged in light of the cost of the raw materials. A lot more goes into the value of a product to the consumer, and it takes a lot more profit to support the successful conduct of a business enterprise than one might think. Price alone is not everything. I am sure that there is a good market for "higher purity" supplements and that some people are willing to pay a premium for added peace of mind.

I do have some objection to the sales approach that paints the competition's product as potentially dangerous because they don't live up to some notional standard of absolute purity.

[nootropi]

I don't think that prices should be judged in light of the cost of the raw materials.  A lot more goes into the value of a product to the consumer, and it takes a lot more profit to support the successful conduct of a business enterprise than one might think.  Price alone is not everything. 

I strongly disagree. I believe in consumers; I think that if offered high quality at lower prices they will flock to the source; thereby awarding the vendor offering such benefits.
Price is everything; it is the difference between settling for half of what you know you need and having it all. When vendors look to their market, they often see profit potential, not people. Just take a look at AOR's prices on R-ALA. What would it cost you to take 900 mg a day? You could not afford it, right? That is, with all the other supplements you take.

Presently, I am building a model that I believe will make high quality encapsultated products available to consumers at less than half the price of the cheapest currently available in today's market. I have significant funds at my disposal (my parent's $ ) and hope to work with smi2le. It may take me a few months to complete; so stay tuned. [thumb]

[zencatholic]

Adam-

I'm looking forward to learning about what you and smi2le have planned!

I agree with you - price IS everything. It is only with the recent advent of much cheaper bulk powders that I have been able to add many supplements to my regimen which I could only dream of adding a few years ago (e.g. ALCAR, carnosine, nootropics). My funds are limited, but my desire to constantly improve my regimen is not.

Peace be with you,
AMDG

Zen Catholic

[nootropi]

Adam-

I'm looking forward to learning about what you and smi2le have planned!

I agree with you - price IS everything.  It is only with the recent advent of much cheaper bulk powders that I have been able to add many supplements to my regimen which I could only dream of adding a few years ago (e.g. ALCAR, carnosine, nootropics).  My funds are limited, but my desire to constantly improve my regimen is not.

Peace be with you,
AMDG

Zen Catholic

Well right now, I am still, I guess you could say, "proposing" to smi2le. Mike already has a great business going -- I just have a slightly different model in mind than he currently uses; however, I need somebody like Rizzer in my model for it to work efficiently and effectively.

It will involve a lot of finances to implement my idea -- and the cash is not mine -- so I have to convince the "investors" (my parents in this case) that I am not throwing their cash down the toilet... [tung]

[scottl]

Nootropi perhaps you need some more nootropics. You are very slow.
You are not wanted here.

[eternaltraveler]

Adam, you are not wanted. I have deleted your posts

[Bruce Klein]

IBC Labs:

Attached Files

•  Pyrixxo.jpg   137.86KB   32 downloads

[LifeMirage]

As much as I would like AOR to carry Pyridoxamine, I think they are more concerned with potential legal issues from BioStratum.

Edited by LifeMirage, 31 July 2005 - 06:00 PM.

[scottl]

As much as I would like AOR to carry Pyridoxamine, I think they are more concerned with potential legal issues from BioStratum.

LifeMirage,

I'm not a lawyer, but I don't understand. BioStratum can't patent pyridoxamine since it has been around being sold. On what basis could there be for a lawsuit? (Biostratum could get a use patent but that wouldn't prevent anyone else from seling it for another purpose).


Smart Nutrition is still selling pyridoxamine, but they have received a lawyer's letter also and it sounds like they may not be selling it for long also.


Oh and Adam's COA above is dated 9/24/03. Is he selling 18 month old product?

Edited by LifeMirage, 31 July 2005 - 06:01 PM.

[LifeMirage]

LifeMirage,

I'm not a lawyer, but I don't understand. BioStratum can't patent pyridoxamine since it has been around being sold. On what basis could there be for a lawsuit? (Biostratum could get a use patent but that wouldn't prevent anyone else from seling it for another purpose).


Smart Nutrition is still selling pyridoxamine, but they have received a lawyer's letter also and it sounds like they may not be selling it for long also.


Oh and Adam's COA above is dated 9/24/03. Is he selling 18 month old product?

Vitamin Research Products was sent a letter warning them of legal action (as far as the FDA is concern they may consider pyridoxamine is a drug because it has a NDA filed before it was sold as a dietary supplement) got afraid and stopped selling it. Smart Nutrition is not afraid of legal action.

Note: It is up to the maker of dietary supplements to prove to the FDA it is a dietary supplement according to the DSHEA act. If it was in research for fda approval or approved before beening sold as a dietary supplement (or sold before 1994) then it is a drug and without fda approve to sell is illegal.

Edited by LifeMirage, 31 July 2005 - 06:01 PM.