USP-COMPLIANT LAB SERVICES
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.
Our Testing Services
NOW OFFERING
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.
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Stability-indicating HPLC methods that separate API from degradation products
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Custom study designs for refrigerated, frozen and room-temperature storage conditions
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Defined pull points with potency, pH, appearance and container-closure assessment
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Documentation packages to support extended beyond-use dating under USP <797>
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Sterility and endotoxin testing integrated at study end points
Request a Stability Study Quote
Starting at $10,000
CATEGORY 2
CATEGORY 3
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.
TYPICAL STUDY OUTLINE
What a stability program covers
Supports
USP <797> Cat 2 & Cat 3 extended BUD
Storage conditions
Refrigerated · Frozen · Controlled RT
Pull points
T0, then defined intervals to BUD
Assays per point
Potency · pH · Appearance
Method type
Stability-indicating HPLC
End-point testing
Sterility · Endotoxin
Deliverable
BUD support documentation
WHY CHOOSE SAPHOBIO
Built for compounding pharmacy workflows
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Fast turnaround times without compromising accuracy
02
Full USP compliance and method validation
03
Dedicated support from our scientific team
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Competitive pricing with volume discounts
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Secure, user-friendly online portal for results and certificates
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Proprietary qPCR-based platform for rapid sterility testing validated with USP <1223>
TALK TO A SCIENTIST
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.
USP-compliant, validated methods
Response within one business day
No obligation — guidance and quotes welcome
For service requests, quotes, or technical questions, email our support team.
info@saphobio.com
Phone
Available Monday to Friday, 9:00 AM – 6:00 PM (Pacific Time).
Text us: +1 (929) 437-6148
Site Visit
Visits by appointment only. Please contact us to schedule.
1068 Washington St. STE B, San Carlos, CA 94070
