Certificates of Analysis

Certificates of Analysis

Every batch of Oriel bacteriostatic water is independently tested by an accredited third-party laboratory before release. We publish the full COA for each batch.

What We Test

  • Sterility - USP <71> membrane filtration
  • Endotoxin - USP <85> LAL test, below 0.25 EU/mL
  • Benzyl Alcohol - HPLC at 0.9% w/v per USP
  • pH - 4.5-7.0 per USP monograph
  • Particulate Matter - USP <788> sub-visible

Batch Numbers

Printed on vial label and outer packaging. Format: ORL-YYYYMM-XXX

Published Certificates

Certificates published here as batches are tested. Subscribe to The Oriel Briefing for notifications.

Sourcing

All BAC water from FDA-registered 503B facilities under cGMP. DEA registered, state pharmacy licensed, FDA inspected. We do not relabel, repackage, or dilute.