Identity confirmation
Intact mass confirmation and retention-time match against reference standard to verify the right peptide is in the vial.
LC-MS · HPLC-UV
Now onboarding founding clients
Peptide testing built for 503B outsourcing facilities.
Identity, purity, potency, endotoxin, sterility and stability testing for peptide APIs and finished sterile preparations, delivered under a quality system designed around cGMP and USP expectations.
RP-HPLC · Purity & related substancesUV 214 nm
- USP-aligned methodsCompendial where they exist, validated where they don't
- cGMP quality systemBuilt to support your 21 CFR Part 211 obligations
- Defensible dataALCOA+ data integrity and second-person review
- Release-ready turnaroundStandard and rush options to keep batches moving
Testing menu
Everything a peptide batch needs before release.
From incoming API qualification to finished-product release and beyond-use date support, one lab and one quality agreement.
Purity & related substances
Chromatographic purity with quantitation of process- and degradation-related impurities such as truncations, deamidation and oxidation.
RP-HPLC / UHPLC
Assay & peptide content
Strength against a qualified reference standard, plus net peptide content so labeled potency reflects the actual peptide present.
HPLC assay · Counterion (TFA / acetate)
Bacterial endotoxins
Endotoxin testing for sterile injectable preparations, with product-specific interference testing during onboarding.
USP <85>
Sterility
Sterility testing for finished sterile preparations, with method suitability performed for each product.
USP <71>
Particulates, pH & more
Subvisible particulate matter, pH, water content and appearance testing for injectable products.
USP <788> · <791> · <921>
Residual solvents & elemental impurities
Screening of peptide APIs for residual process solvents and elemental impurities.
USP <467> · <232> / <233>
Incoming API qualification
Independent verification of supplier certificates of analysis before a peptide API enters your compounding process.
Identity · Purity · Content
Method development & validation
Stability-indicating method development, validation and transfer for peptides without a compendial monograph.
USP <1225> / <1226> · ICH Q2(R2)
Stability programs
Stability and beyond-use date studies
Peptides degrade, and 503B facilities need data to support the dating on every label. We design and run stability protocols that track potency, purity and degradants across storage conditions and timepoints, so your BUDs are backed by evidence.
- Protocol design around your formulation and container closure
- Real-time and accelerated storage conditions
- Stability-indicating purity and assay at every pull
- Summary reports ready for your quality records
Who we serve
A partner for pharmacies held to a higher standard.
503B
Outsourcing facilities
Release testing, stability data and API qualification from a lab that understands cGMP expectations and FDA inspection readiness.
503A
Compounding pharmacies
Potency, sterility and endotoxin testing that supports USP <797> programs and gives your patients and prescribers confidence.
API
Peptide suppliers
Independent third-party testing that lets your customers verify what your certificates of analysis say.
Quality & compliance
Built for the inspection, not just the result.
A certificate of analysis is only as good as the system behind it. We are building our quality system to the standard your auditors expect, and we're open about where each piece stands.
Our commitment: we will only claim an accreditation once it is granted. When it is, our scope of accreditation will be published here.
Accreditation
ISO/IEC 17025:2017 In progress
Our quality management system is being built to ISO/IEC 17025 requirements for testing laboratory competence, impartiality and consistent operation.
cGMP
21 CFR Part 211 alignment
Documented procedures, qualified equipment, trained analysts and investigations (OOS/OOT) handled the way a cGMP contract lab should.
Data integrity
ALCOA+ and Part 11-ready systems
Audit-trailed instrument data, controlled electronic records and second-person review on every reported result.
Agreements
Quality agreement with every client
Clear responsibilities for testing, change control, deviations and notification, in writing before the first sample arrives.
Audits
Open to client audits
Your quality team is welcome to audit our lab, procedures and records.
How it works
From first call to certificate of analysis.
Scope & agree
We review your products, specifications and release needs, then put a quality agreement and pricing in place.
Onboard methods
We confirm method suitability for each product, or develop and validate methods where no monograph exists.
Ship samples
Submit samples with our chain-of-custody form. We log receipt, condition and storage the day they arrive.
Receive your COA
Results are reviewed by a second analyst and released on a signed certificate of analysis, with raw data available on request.
About us
Precision is in the name.
Precision Analytical Sciences is an independent analytical testing laboratory focused on peptides and the pharmacies that compound them.
Demand for compounded peptide therapies has grown faster than the testing capacity built to support them. Outsourcing facilities need a lab partner that speaks their language: cGMP, USP, quality agreements, BUDs and inspection readiness. We were founded to be that partner.
Our team has built and operated clinical laboratories before. We bring that experience to a lab designed from day one around peptide chemistry, data integrity and responsive service.
Look closely at our logo and you'll find a chromatogram at the heart of the tree. That is the work we do.
FAQ
Common questions.
Are you ISO/IEC 17025 accredited?
Not yet. We are building our quality system to ISO/IEC 17025:2017 and working toward accreditation. We will only state that we are accredited once it is granted, and we will publish our scope of accreditation on this site.
What is the founding client program?
We are onboarding a limited number of early clients. Founding clients help shape our test menu and turnaround commitments and receive preferred pricing. Contact us to learn more.
Which peptides can you test?
Our methods are built for synthetic peptide APIs and finished preparations. Tell us which peptides and dosage forms you work with and we will confirm method availability, or scope method development and validation.
Do you sign quality agreements?
Yes. Every client relationship starts with a written quality agreement that defines responsibilities for testing, deviations, out-of-specification investigations, change control and communication.
How do I send samples?
Once your account is set up, we provide sample submission forms, chain-of-custody documentation and shipping and storage instructions specific to each product.
Contact
Let's talk about your testing needs.
Tell us about your facility and products. We will follow up within one business day.