Contract Laboratory
Our scope covers the identity, purity, safety, and stability parameters required for release testing of research-grade peptides and small-molecule compounds. All methods adapted from USP, EP, and ICH guidelines with full instrument data retained.
Purity
High-performance liquid chromatography with UV detection (214 / 280 nm). C18 reverse-phase column chemistry, gradient elution with water / acetonitrile / 0.1% TFA mobile phases. Suitable for peptides, small molecules, and derivatized compounds. Reported to 0.1% precision. Full chromatogram included with every certificate.
Method USP <621> Chromatography
Identity
Liquid chromatography-mass spectrometry for identity confirmation. Positive and negative mode electrospray ionization. Observed monoisotopic mass compared against theoretical mass with tolerances aligned to USP guidelines.
Method USP <736> Mass Spectrometry
Safety
Kinetic chromogenic Limulus amebocyte lysate assay. Quantitative endotoxin determination to 0.005 EU/mL detection limit. Reported in EU/mg of active compound. Sample preparation per client-supplied dilution protocol or default per-mg dilution.
Method USP <85> Bacterial Endotoxins Test
Stability
Coulometric Karl Fischer titration for lyophilized samples and volumetric for solution samples. Suitable for peptides, solid-state APIs, and hygroscopic compounds. Quantitative water determination with high precision.
Method USP <921> Method 1c / 1a
Safety
Headspace gas chromatography with mass spectrometry detection. ICH Q3C Class 1, 2, and 3 solvent screening. Quantitative reporting against pharmacopeial limits.
Method USP <467> Residual Solvents
Identity
Enzymatic digestion with trypsin, chymotrypsin, or Lys-C followed by LC-MS/MS sequence confirmation. Coverage maps and peptide assignment table delivered with the certificate.
Method USP <1055> Biotechnology-Derived Articles
Frequently Asked
Typically 5–10 mg of dry powder is sufficient for HPLC purity, identity (LC-MS), and a retained sample. For full panels including LAL and Karl Fischer, we recommend 25 mg.
Standard turnaround is 5 business days from sample receipt for the Standard Panel and 7 business days for the Extended Panel. Rush 3-day service is available at +50%.
Yes. SteriGenix specializes in research-use-only peptides and small-molecule compounds. We do not test materials intended for human consumption.
Every COA includes the analytical methods used, raw chromatograms, mass spectra, quantitative results, lot identifiers, and a unique batch ID that anyone can verify on our public /verify portal.
Our kinetic chromogenic LAL assay has a detection limit of 0.005 EU/mL, meeting USP <85> requirements for parenteral release testing.
Yes. Methods are adapted from USP, EP, and ICH guidelines, including USP <621> for HPLC, USP <85> for bacterial endotoxins, USP <921> for water content, and USP <467> for residual solvents.
SteriGenix Lab
Independent peptide analytics
