Why and How to Test your Rapamycin (2)

Continued from Why and How to Test your Rapamycin (part 1)

Some contaminants, like nitrosamines, have been found numerous times in generic medications and are linked to increased risk of cancer. A recent analysis by Valisure - a leading pharmaceutical analysis company - identified this a type of nitrosamine called NMDA in a significant number of batches of metformin, a drug that people typically take for treatment of diabetes, but which is increasingly taken by people for anti-aging purposes.

Valisure had this to say in their press release:

Valisure has tested and detected high levels of N-Nitrosodimethylamine (NDMA) in specific lots of the drug metformin, a prescription medication used to control high blood sugar in adults and adolescents with type 2 diabetes.

Valisure’s analysis of 22 companies selling metformin and a total of 38 batches revealed 16 batches and 11 companies where NDMA levels were detected above the 96 nanograms (ng) daily acceptable intake limit. Several batches contained over 10 times the daily acceptable intake limit and there was significant variability from batch to batch, even within a single company. These findings underscore the importance of batch-level chemical analysis and the necessity of effective quality surveillance of medications.

As a result of this announcement, many companies were forced to recall millions of doses of metformin from the market. The FDA had this to say about the entire metformin contaminant issues.

This is from a regular generic medicine (metformin is the most popular drug used in America) that is sold all over the United States.

The Need for Testing / and Testing Results

Katherine Eban, in her book, suggests that India pharmaceutical companies have different quality standards for different products destined for different countries in the world. Pharmaceuticals destined to countries in Africa, for example, have the lowest quality standards because they have the lowest regulatory standards and are unlikely to check on the product quality, and because they are the most price conscious (want the cheapest possible medication).

Products developed for the USA and Europe tend to have much higher quality - but if you are purchasing the product in India - you are most likely not buying the product that is manufactured for the USA or Europe - so the risk of quality problems and contaminants is higher.

Our User’s Experience Testing India Sourced Sirolimus

As an example, one of our rapamycin users ordered a number of different batches of sirolimus from different manufacturers in India and had them tested at Valisure. There were two batches of Biocon Rapacan (Sirolimus) and one batch of Zydus Siromus (sirolimus).

As can be seen from the test results below - the Bicon product seems to have some type of contaminant or filler in their tablets, much more so than the Zydus siromus. Its probably benign, but we don’t know for sure. You can also see the product quality/dose varied by batch. Overall, no major flags were brought up in our testing of these batches of sirolimus which suggests the short term product quality risk when taking rapamycin (at least the Zydus Sirolimus and to a lesser extent the Biocon Rapacan versions tested) from India is not extremely high, but longer term we believe that since this is a drug that people may, theoretically, use their entire life, we believe that we really want to be sure that it is free of contaminants and of high quality. For this reason we think its a good idea to test rapamycin or purchase rapamycin from batches that have been tested and confirmed in terms of quality, dose and lack of contaminants.

Rather than testing your own medicines, another approach becoming more popular in the USA purchasing your medicines from a pharmacy that tests the batches of medicines before delivering them to customers. Valisure provides this service to many pharmacies, so you can find a pharmacy that uses Valisure’s testing, or find a pharmacy that does its own testing.

One online pharmacy that we know has partnered with Valisure for medicine quality validation is called Medly. You can find them here: https://medly.com . If you know of other pharmacies that validate the quality/purity of their medicines please post them by clicking on the “reply” button at the bottom of this page.

If you can’t find good pricing on laboratory analysis of the pharmaceuticals (sadly, Valisure is no longer offering the service to end users for personal medicine) people are purchasing sirolimus product that is being used in clinical trials in the USA. For example - the Zydus Siromus is the brand I believe is being used in the University of Washing clinical trials for rapamycin being conducted as part of the Dog Aging Project.

Below is the Valisure product quality test results. If you have web content blockers turned on in your browsers you will see a “content blocked” message. You can either remove the blocking for this website, or you can download the document to view it.

Note: When you get your products lab quality tested - please post the results so everyone can learn from them.

Valisure_Report_191217319401.pdf (354.9 KB)

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Hello, my name is Ross Pelton and I am The Natural Pharmacist. My website, bio and blog are at: naturalpharmacist.net I have several topics I want to discuss.
TOPIC #1: I have just finished writing a book titled Rapamycin, mTOR, Autophagy & Treating mTOR Syndrome. Here is a link to my book: RAPAMYCIN mTOR AUTOPHAGY & Treating “mTOR Syndrome” - Life Extension

TOPIC #2: RAPAMYCIN DOSING. I believe this varies substantially between individuals. We are just learning. I started taking rapamycin 6 mg/week about 8 months ago. Last month my labs revealed that I had become quite anemic. My iron, hemoglobin, etc were all quite low. I have reduced my dosing to 6 mg every other week. Over inhibition of mTOR can suppress production of RBCs resulting in anemia. I will report my progress when I get next set of labs.

NEXT TOPIC: Quality of sirolimus generics vs Rapamune. Rapamune was the first drug to receive FDA approval to be market as a nanoparticle drug. Rapamune® tablets are composed of rapamycin nanocrystals. I recently did some investigation and learned that two of the largest Indian generic drug companies that market sirolimus ARE NOT using the nanocrystal technology. Therefore, I fear that the absorption and resulting plasma levels of these generics would be far lower than that of Rapamune. I hope someone in our Life Extension Community can do actual comparisons between Rapamune and generic sirolimus to test outcomes.

That’s all…I look forward to staying in touch with you all… Ross

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may be the nano-particle Rapamune is too strong and effective to cause your anemia?nanoRAPA

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Very interesting. @DrRoss can you share the identity of the two vendors you have heard do not use the nanocrystal technology in their formulation of sirolimus? With the recent availability of the new LEF Sirolimus blood test for $95 it would be easy to compare the bioavailability and I know some people are already doing this test - so we would just need to identify the sirolimus version they are using and then compare the blood test results.

Also - Some resources on this issue:

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The filler in Rapacon is titanium dioxide. It is plainly listed on their label.
“One of the most widely used food pigments is titanium dioxide, an odorless powder that enhances the white color or opacity of foods and over-the-counter products, including coffee creamers, candies, sunscreen, and toothpaste”. Who knows how much you have already ingested? Not recognized as safe as it once was.
Rapacon tablets are White. Zydus tablets are brownish/tan.
Hope this helps. I have been taking Rapacon only because it is more widely available and cheaper.
[apacon|666x500(upload://z3vaBPMfO0DoX8zR14vNyZEeqXo.jpeg)

P.S
I don’t seem to know how to upload pictures. What gets uploaded is a gobbledygook pointer that actually doesn’t work. I see the picture while I am editing, but when I send the post, it disappears. I use Chromebook and the Google browser.

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Hi Dr. Ross - could you post the table of contents of your new book so that we can see what you are covering in it?

It sounds really interesting - but I’m wondering if its more targeted at people who are entirely new to the world of rapamycin - and not people here who have frequently already read many of the research papers on rapamycin and mTOR.

Thanks,

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Yes…many people who are life extension enthusiasts may be familiar with much of the material I’ve written about. One of my goals in writing this book was to summarize and consolidate the science supporting the use of rapamycin…to educate physicians & the public about the potential health benefits of rapamycin.

A second goal is to publicize the mTOR/autophagy relationship. It provides a totally new understanding of cellular biochemistry, health and aging. This information can help improve the health and longevity of most people alive today. Healthy regards, Ross

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I agree, and how many pages a book has. The book could also be a gift for friends who doesnt know a thing about rapa.

Care to share where you purchase Rapacon from? Thanks.

This is how I started my first order:

Dipesh Chhajed <dipesh.chhajed@gmail.com

http://www.welcomehealthcare.co.in/

Dear Mr. Dipesh:

I would like to order: Rapacan Biocon, Sirolimus 1mg Tablets

Total: 100 Tablets.

Please send me an invoice for ordering.

This is not an endorsement or recommendation.

I have received two orders successfully from this person.

He is not the absolute cheapest, but he does accept PayPal

The order will be sent by India Post with a valid mail tracking number.

It takes 3 to 6 weeks for delivery to your home.

This is what I paid:

10.0 x RAPACAN 1mg $110.00 USD

$11.00 USD

Sirolimus 1mg Tablet 100Tablets

Subtotal $110.00 USD

Discount $0.00 USD

Shipping $30.00 USD

Invoice Total $140.00 USD

Amount paid -$140.00 USD

Amount due $0.00 USD

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Have you received the order yet - or just placed the order? Please let us know when you do receive it, if you’ve only just ordered it.

Yes, I have successfully received two orders with no problems.
As I pointed out big plus factor for me is that he accepts PayPal, which offers some recourse if there is a problem with delivery.

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Anecdotal but I bought slightly cheaper zydus siromus a few months ago instead of rapacan, because the latter was out of stock. I wondered if that’s a good idea because cheaper may also mean worse quality sometimes. However, I subjectively felt that zydus siromus felt “smoother” and “cleaner” so I continued with that. I think with rapacan I had experienced muscle twitches occasionally which seemed absent with siromus.

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The valise lab test on Zydus sirolimus / siromus was fine - so that seems like a reasonable strategy for you. I’ve not seen any rapacan purity/dosing lab evaluations.

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Thank you so much for sharing this info. I went to their site and do not see Rapacan Biocon, Siromilus even listed. Does it require a special inquiry to them?

You might just email them and ask about pricing and availability of the products you are interested in.

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I do not see on his website any of the rapamycin products?

Yes I had to email him with an inquiry of the product( Sirolimus 1mg)

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I made a similar order with Dipesh Chhajed a couple of months ago and received it within three weeks. But, recently I’ve sent several emails to him about a potential Dasatinib order and I’m not receiving any response. Well, I guess I’ll have to find another vendor.

I have had a similar experience. He is very good at supplying Rapacan Sirolimus but was unresponsive to my requests for anything else. After I run out of my present supply I am going to try another vendor and give Zydus brand a try and see if I can tell the difference in results.