Every released TrueBac lot has a published report from an independent U.S. laboratory. This guide explains how to read it, and how to confirm the report you are reading is the one we published.
1. The header
- Lot number: matches the label on your vial and the packing slip in your order.
- Laboratory and accreditation: the testing laboratory and its ISO/IEC 17025 accreditation reference.
- Sampled / reported: when samples were drawn and when results were issued.
2. The results table
Each row gives the test, the method used, the specification (the acceptance limit), the result, and whether the result conforms.
| Test | What it tells you |
|---|---|
| Sterility (USP <71>) | Whether viable microorganisms grew from the samples tested during incubation. |
| Bacterial endotoxins (USP <85>) | The level of endotoxin, a pyrogenic component of bacterial cell walls, in EU/mL. |
| Particulate matter (USP <788>) | Counts of sub-visible particles at ≥10 µm and ≥25 µm. |
| pH | Acidity of the solution, which can drift slightly as the preservative ages. |
| Benzyl alcohol assay | Preservative concentration, typically by HPLC, against the 0.9% w/v target. |
| Identity | Confirms the preservative present is benzyl alcohol. |
3. What testing cannot tell you
A sterility test examines a sample of units from a lot. A passing result means no growth was detected in those units under the test conditions. It cannot prove that every unit in the lot is sterile: a low rate of contamination can go undetected by any practical sample size. That is why we pair testing with a quarantine-and-release system, lot traceability, and a published recall procedure, and why your own aseptic technique still matters.
4. Verifying a report
- Scan the code on the vial label, or enter the lot number at truebacwater.com/verify.
- The lot record shows the SHA-256 fingerprint of the published PDF. If you have a copy from elsewhere, hash it and compare: a single changed byte changes the fingerprint.