From facility to vial, AuraBac is built around traceability and release testing — so your compliance, audit, and inventory records stay airtight.
Produced in a facility operating under EU Good Manufacturing Practice, with documented procedures for every production step.
Filled and sealed on an ISO Class 5 line to maintain sterility from solution to closure.
No lot ships until it passes sterility, endotoxin, and particulate testing — each result captured on the Certificate of Analysis.
Testing is performed against defined release criteria. The COA accompanying your order documents each result alongside lot number and expiry.
| Test | Result |
| Sterility | Conforms |
| Endotoxin (LAL) | Within limit |
| Particulate matter | Conforms |
| Appearance | Clear, colorless |
| pH | 4.5 – 7.0 |
| Benzyl alcohol | 0.9% w/v |
| Lot / Expiry | Documented |
Illustrative example. Actual values appear on the COA supplied with each lot.
USP water for injection compounded with 0.9% benzyl alcohol under controlled conditions.
Filled on an ISO Class 5 line, stoppered, and capped with tamper-evident flip-off closures.
Lot held pending sterility, endotoxin, and particulate results, then released with a COA.
AuraBac verifies that purchasers are licensed clinics, pharmacies, compounding facilities, research institutions, or credentialed practitioners before fulfilling orders. We maintain lot traceability to support recall readiness and audit requirements, and we expect all product to be used in accordance with applicable laws, label directions, and professional judgment.
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