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.

10+
Years Combined Experience
3–5
Business Days Standard Turnaround
USP · EP
Pharmacopeia Method References
3 yr
Instrument Data Retention

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

01

Sample Submission

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

02

Analysis

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

03

Certificate Delivery

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

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