For brands, manufacturers & compounding pharmacies

Lot release and stability testing, results in days, not weeks.

Sapho Bio is a third-party testing lab for lot release testing and stability studies. Our proprietary qPCR rapid sterility test gives results in 2 business days, not 14. A team of scientists and engineers delivers rapid, high-quality results to customers nationwide.

2bd
qPCR rapid sterility, aqueous lots (USP <71>: 14-day incubation)
30+
503A Pharmacy Customers
0
Form 483s or FDA warning letters
60+
Controlled SOPs, versioned in Benchling

Test menu

Turnaround in business days
ServiceMethodTAT
Lot release
qPCR Rapid SterilityProprietaryValidated per USP <1223>USP <1223>2–5
Bacterial EndotoxinsUSP <85>2–5
Potency / APIHPLC2–5
Stability studies
Stability-Indicating PotencyUSP <1225>5
Sterility, membrane filtrationUSP <71>12
Antimicrobial EffectivenessUSP <51>30
Container Closure IntegrityUSP <1207>2
Sub-visible ParticulatesUSP <788>2
Visible ParticulatesUSP <790>2
Usable Fill Volume · pHUSP <697> · <791>2

Matrices: aqueous, oil and lyophilized. Method development is quoted per project.

Quality and compliance

  • DEA registration for controlled substances, such as testosterone
  • No Form 483s and no warning letters
  • Methods validated per USP <1223> or <1225>: repeatability, ruggedness, LOD
  • Instruments qualified routinely (IQ/OQ/PQ)
  • Trained scientists 60+ SOPs; CAPA database maintained
  • ISO/IEC 17025 accreditation assessmentQ4 2026
  • FDA registration with our quality management systemPending

In placeIn progress

Client portal

  1. 01Register lot
  2. 02Order tests
  3. 03Log shipment
  4. 04Track status
  5. 05Signed COA

Web portal. Do the full workflow online. Your data is visible only to your account. An API for connecting your own systems is available on request.