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)