Dustycotton
GLP-1 Novice
Posting here since I cannot post in the Lab Testing forum. If a mod wants to move this thread to the testing forum, please do.
Recent testing results that I personally paid for and not part of any group buy or group testing. Details below and results attached.
Vendor: AmoPure (name at the time of order, now BFFList)
Product: L60 (Tirz 60mg) x 2 kits
Ship Date: 8/29/2024
Batch Number: None. Batch numbers were not added to kits until after this order
Samples sent: 4 vials, 2 from each kit received in the order
Tests: Sterility tested from 3 vials. Endotoxin on one vial (sterility and endotoxin tests each require separate vials).
Results: Sterility negative/pass. Endotoxin within acceptable limits.
About My Endotoxin Test
60 mg vial of tirzepatide. The test report shows:
I inject 15 mg: 15 mg × 0.167 EU/mg = 2.505 EU per dose
To compare with safety guidelines:
My weight is 106 kg: 106 kg × 5 EU = 530 EU per dose is the acceptable limit set by FDA and USP
At 2.505 EU per 15 mg dose, this is far below the 530 EU limit and would be considered a low level, acceptable for typical subcutaneous use.
Other Details from the Test
Endotoxin test result interpretation provided to me:
Endotoxin Limits & How to Read Them
For injectable products (including peptides), regulatory guidelines such as those from the FDA and USP generally set a limit of around 5 EU per kilogram of body weight per dose. Lyophilized peptides are often measured in EU per milligram (EU/mg), allowing you to calculate exposure based on the amount you plan to use.
Example Using Tirzepatide
Suppose you have 60 mg of tirzepatide that tests at 2.76 EU total.
2.76 ÷ 60 = 0.046 EU/mg.
By most standards, that's a relatively low amount — but whether it is “acceptable” depends entirely on the intended use and the applicable guidelines.
How We Report Endotoxin Results
We keep it simple and report the total EU per sample.
If you know the mass of your sample, you can easily convert it to EU/mg if needed, allowing you to evaluate the results based on the specific application.
A Few Other Things to Keep in Mind
Recent testing results that I personally paid for and not part of any group buy or group testing. Details below and results attached.
Vendor: AmoPure (name at the time of order, now BFFList)
Product: L60 (Tirz 60mg) x 2 kits
Ship Date: 8/29/2024
Batch Number: None. Batch numbers were not added to kits until after this order
Samples sent: 4 vials, 2 from each kit received in the order
Tests: Sterility tested from 3 vials. Endotoxin on one vial (sterility and endotoxin tests each require separate vials).
Results: Sterility negative/pass. Endotoxin within acceptable limits.
About My Endotoxin Test
60 mg vial of tirzepatide. The test report shows:
- Endotoxin result: less than 10.0 EU/mL
- Dilution volume: 2 mL total
I inject 15 mg: 15 mg × 0.167 EU/mg = 2.505 EU per dose
To compare with safety guidelines:
My weight is 106 kg: 106 kg × 5 EU = 530 EU per dose is the acceptable limit set by FDA and USP
At 2.505 EU per 15 mg dose, this is far below the 530 EU limit and would be considered a low level, acceptable for typical subcutaneous use.
Other Details from the Test
- Spike Recovery: 79% (valid range is generally 50%–200%)
- Sample CV: 0.0% (very stable)
- Spike CV: 1.0% (also indicates good consistency)
Endotoxin test result interpretation provided to me:
Endotoxin Limits & How to Read Them
For injectable products (including peptides), regulatory guidelines such as those from the FDA and USP generally set a limit of around 5 EU per kilogram of body weight per dose. Lyophilized peptides are often measured in EU per milligram (EU/mg), allowing you to calculate exposure based on the amount you plan to use.
Example Using Tirzepatide
Suppose you have 60 mg of tirzepatide that tests at 2.76 EU total.
2.76 ÷ 60 = 0.046 EU/mg.
By most standards, that's a relatively low amount — but whether it is “acceptable” depends entirely on the intended use and the applicable guidelines.
How We Report Endotoxin Results
We keep it simple and report the total EU per sample.
If you know the mass of your sample, you can easily convert it to EU/mg if needed, allowing you to evaluate the results based on the specific application.
A Few Other Things to Keep in Mind
- Different uses = different limits — Products intended for spinal injections or sensitive cell work require much tighter endotoxin thresholds.
- Testing accuracy — We perform spike recovery checks on all tests to verify accuracy, and these controls are reflected in the data you receive.
- Use case matters — Whether a result is considered "safe" ultimately depends on how the material is used and what guidelines apply.
Attachments
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