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Notablequoteable’s Notes From A Conversation With A Lab Director (Part 1, maybe)
The Context:
Not long ago I started the least fun part of the peptide journey: figuring out which tests I wanted to perform to confirm the safety and efficacy of the peptides I’d purchased for my research, and which lab I wanted to perform them.
I started my outreach by sending a few emails, but also ended up calling an FDA accredited lab that offers peptide testing as a service to inquire about their prices. I ended up speaking with the lab director who provided some interesting insight into how compounding pharmacies and drug manufacturers test drugs for human safety.
The Gold Standard:
Compounding pharmacies and drug manufacturers who are testing the safety and efficacy of injectable medications perform the following tests:
Purity (purity and mass in mgs)
Sterility (USP 71 sterility test)
Endotoxins (presence test)
Most people reading this should understand the importance of testing for purity and mass. It’s necessary to confirm that you’ve received the correct substance, that it was manufactured correctly, and you received it in the quantity that you ordered.
The most interesting part of our conversation was about sterility testing practices, and the difference between the two most common sterility tests.
USP 61 vs USP 71
If you’ve ever stumbled across a sterility test in the wild, you’ve probably seen the USP 61 which involves assigning pass or fail values to the TAMC (Total Aerobic Microbial Count) and TYMC (Total Combined Yeasts/Molds Count). The pass/fail nature of this test is reflective of the fact that it is designed for non-sterile products. The presence of some bacteria, mold, and yeast is acceptable within thresholds determined by the route of administration. There is no expectation that oral tablets which pass through the digestive system, or creams applied to unbroken skin be completely free of yeast or molds. As such, a “pass” in one of these areas on a USP 61 does not mean the substance is sterile, but that any bacteria or yeast present are below certain predetermined thresholds.
USP 71 is a test designed for products that must be sterile including injectable medications. The primary differences between the USP 71 and USP 61 is that the presence of any bacteria, yeast, or mold can cause a test failure, and the length of time the test takes. Most USP 61 tests are completed within 4-5 days, but USP 71 tests take place over a period of two weeks (14 days).
Rapid Sterility Test
Because of the length of time the USP 71 takes, some labs offer a “Rapid Sterility” test that aims to provide the same value as the USP 71, but can be completed in as little as 6 days. It uses specialized equipment to detect bacterial growth more quickly, but is also more expensive.
The Context:
Not long ago I started the least fun part of the peptide journey: figuring out which tests I wanted to perform to confirm the safety and efficacy of the peptides I’d purchased for my research, and which lab I wanted to perform them.
I started my outreach by sending a few emails, but also ended up calling an FDA accredited lab that offers peptide testing as a service to inquire about their prices. I ended up speaking with the lab director who provided some interesting insight into how compounding pharmacies and drug manufacturers test drugs for human safety.
The Gold Standard:
Compounding pharmacies and drug manufacturers who are testing the safety and efficacy of injectable medications perform the following tests:
Purity (purity and mass in mgs)
Sterility (USP 71 sterility test)
Endotoxins (presence test)
Most people reading this should understand the importance of testing for purity and mass. It’s necessary to confirm that you’ve received the correct substance, that it was manufactured correctly, and you received it in the quantity that you ordered.
The most interesting part of our conversation was about sterility testing practices, and the difference between the two most common sterility tests.
USP 61 vs USP 71
If you’ve ever stumbled across a sterility test in the wild, you’ve probably seen the USP 61 which involves assigning pass or fail values to the TAMC (Total Aerobic Microbial Count) and TYMC (Total Combined Yeasts/Molds Count). The pass/fail nature of this test is reflective of the fact that it is designed for non-sterile products. The presence of some bacteria, mold, and yeast is acceptable within thresholds determined by the route of administration. There is no expectation that oral tablets which pass through the digestive system, or creams applied to unbroken skin be completely free of yeast or molds. As such, a “pass” in one of these areas on a USP 61 does not mean the substance is sterile, but that any bacteria or yeast present are below certain predetermined thresholds.
USP 71 is a test designed for products that must be sterile including injectable medications. The primary differences between the USP 71 and USP 61 is that the presence of any bacteria, yeast, or mold can cause a test failure, and the length of time the test takes. Most USP 61 tests are completed within 4-5 days, but USP 71 tests take place over a period of two weeks (14 days).
Rapid Sterility Test
Because of the length of time the USP 71 takes, some labs offer a “Rapid Sterility” test that aims to provide the same value as the USP 71, but can be completed in as little as 6 days. It uses specialized equipment to detect bacterial growth more quickly, but is also more expensive.
