What sample size do you need?

5–10 mg for HPLC + LC-MS; 25 mg for full panels including LAL and Karl Fischer.

How fast is turnaround?

Standard 5 business days. Extended panels 7 days. Rush 3-day service available at +50%.

Are your methods USP-compliant?

Yes — adapted from USP , , , and ICH Q3C. Validation packages available on audit.

Can clients verify a CoA?

Every batch has a unique ID anyone can verify on our public /verify portal.

Contract Analytical Laboratory

Independent analytical testing for research compounds and raw ingredients.

SteriGenix provides HPLC purity, mass spectrometry, bacterial endotoxin, and residual solvent testing for research laboratories, supplement manufacturers, and contract formulators. Fast turnaround. Transparent reporting. US-based operations.

Estimate Your Price Verify a Certificate Our Analytical Services

Instrumentation

Agilent · Waters · Shimadzu · Metrohm · Charles River Endosafe

Method References

USP <85> · USP <621> · USP <736> · USP <921> · USP <467> · ICH Q3C

10+

Years Combined Experience

3–5

Business Days Standard Turnaround

USP · EP

Pharmacopeia Method References

3 yr

Instrument Data Retention

Quality & Compliance

Built around audit-ready standards.

ISO 17025-aligned

Quality management system aligned to ISO/IEC 17025 for testing and calibration laboratories.

USP & ICH methods

Methods adapted from USP <85>, <621>, <736>, <921>, <467>, and ICH Q3C harmonized guidelines.

Qualified instruments

Agilent, Waters, Shimadzu, Metrohm, Charles River Endosafe — IQ/OQ/PQ on file, traceable calibration.

Audit-ready records

Raw chromatograms, spectra, and chain-of-custody retained 3+ years and released to clients on request.

SteriGenix operates under an ISO 17025-aligned quality system for research-use-only testing. We are not a cGMP-registered facility and do not release material for human clinical use. Validation documentation is available to clients on request under a signed audit agreement.

Services

Core Analytical Panel

Our scope covers the identity, purity, safety, and stability parameters required for release testing of research-grade peptides and small-molecule compounds. Methods adapted from USP, EP, and ICH guidelines.

Purity

Reverse-Phase HPLC

Gradient elution on C18 with UV detection. Full chromatogram reported to 0.1% precision.

Identity

LC-MS Identification

ESI in positive and negative modes per USP <736>. Mass accuracy ±0.01 Da.

Safety

Bacterial Endotoxins (LAL)

Kinetic chromogenic LAL per USP <85>. Detection to 0.005 EU/mL.

Stability

Karl Fischer Water Content

Coulometric titration per USP <921> Method 1c. Suitable for lyophilized peptides.

Safety

Residual Solvents (GC-MS)

Headspace GC-MS per USP <467>. ICH Q3C Class 1–3 screening.

Identity

Peptide Mapping

Tryptic or chymotryptic digestion followed by LC-MS/MS sequence confirmation.

Verification

Verify a Certificate of Analysis.

If you received a product bearing a SteriGenix Certificate of Analysis, you can verify its authenticity by entering the batch identifier. Each batch we analyze is tracked under a unique identifier assigned at sample receipt.

Look Up a Batch

Process

From Sample Submission to Certificate

Sample Submission

Clients request a submission number and ship samples via prepaid label. Minimum sample size varies by assay.

Analysis

Standard turnaround for single-parameter assays is 3–5 business days. Full release panels run 5–7 days.

Certificate Delivery

Results are delivered as signed PDF. Each certificate is retrievable publicly via its batch identifier.

In their words

Trusted by research suppliers and formulators.

"Turnaround was actually 4 days, not the promised 5 — and the chromatograms were the cleanest I've seen from any contract lab. Switched our entire purity panel to SteriGenix."

Dr. M. Ortega

Director of Quality, peptide research supplier

"We needed a third-party LAL on a recalled batch and they had results in 72 hours with full method documentation. Saved a customer relationship."

J. Whitman

Operations Lead, contract formulator

"The /verify portal cut our customer-service tickets in half. Buyers stopped asking for COAs — they just look them up."

Anonymous client

Research peptide retailer

Common Questions

Before you ship.

Read the full FAQ

What sample size do you need?: 5–10 mg for HPLC + LC-MS; 25 mg for full panels including LAL and Karl Fischer.
How fast is turnaround?: Standard 5 business days. Extended panels 7 days. Rush 3-day service available at +50%.
Are your methods USP-compliant?: Yes — adapted from USP <85>, <621>, <921>, <467> and ICH Q3C. Validation packages available on audit.
Can clients verify a CoA?: Every batch has a unique ID anyone can verify on our public /verify portal.

Ready to submit a sample?

Contact us for a submission number, current price list, and preferred shipping protocol. We respond within one business day.

Contact the Lab