Sterile compounding pharmacy testing — results in hours, not weeks.
Fast, accurate testing services for compounding pharmacies. USP-compliant methods with rapid turnaround times — so you can release compliant product sooner and catch problems early.
Comprehensive lot release testing
Industry-leading turnaround times across sterility, potency, endotoxin and pH — validated to USP standards for sterile compounding.
qPCR Rapid Sterility
Sterility results in 48 hours — not two weeks. Whether a batch passes or fails, faster answers mean faster decisions: release compliant product sooner, or catch contamination early enough to recompound before inventory backs up. Priced competitively to replace your current testing method, not supplement it.
USP <71> Compendial Sterility
The traditional gold-standard compendial sterility method. Universally accepted by all regulatory bodies and ideal for pharmacies that prefer the established approach.
Potency & Conformity Testing
Quantify the amount of API in your formulation for compliance with USP <797>. Multi-API formulas tested per ingredient.
Endotoxin Testing
USP <85> bacterial endotoxin testing using LAL methodology for patient safety assurance. Sensitive detection down to 0.01 EU/mL.
pH Testing
pH measurement for compounded preparations to verify formulation stability and compliance specifications.
USP <797> Stability Studies
Extend your beyond-use dates with confidence. Our stability programs generate the chemical and physical data you need to support extended BUDs for your compounded sterile preparations — backed by validated, stability-indicating methods.
These studies generate the stability data required to qualify for the extended beyond-use dates that USP <797> permits for Category 2 and Category 3 CSPs — going well beyond the default short-dating limits.
- Stability-indicating HPLC methods that separate API from degradation products
- Custom study designs for refrigerated, frozen and room-temperature storage conditions
- Defined pull points with potency, pH, appearance and container-closure assessment
- Documentation packages to support extended beyond-use dating under USP <797>
- Sterility and endotoxin testing integrated at study end points
What a stability program covers
Built for compounding pharmacy workflows
Fast turnaround times without compromising accuracy
Full USP compliance and method validation
Dedicated support from our scientific team
Competitive pricing with volume discounts
Secure, user-friendly online portal for results and certificates
RNA-based qPCR platform that works with your existing equipment
From sample to certificate
A streamlined workflow that keeps you in control at every step.
Ship your samples
Send your samples to the SaphoBio laboratory.
Track in real time
Follow testing progress in real-time through our portal.
Receive certificates
Get certificates delivered via our secure portal.
Access your data
Access historical results and certificates anytime.
Tell us what you need tested
Whether you need testing guidance, a quote, or just have questions — we're here. A scientist will follow up within one business day.
For service requests, quotes, or technical questions, email our support team.
Site Visit
Visits by appointment only. Please contact us to schedule.
San Carlos, CA 94070
