Analytical quality framework

MX-1 Labs distributes research peptides with a comprehensive analytical framework. Every vial arrives with its batch-specific Certificate of Analysis covering identity, purity, water content, endotoxins, and amino acid composition.

Each batch is characterized by reversed-phase high-performance liquid chromatography (RP-HPLC) with UV detection. Specification: purity ≥99% by peak area. The chromatogram is attached to the CoA with retention times, gradient parameters, and column used.

Peptide identity is confirmed by mass spectrometry (LC-MS or MALDI-TOF). The observed molecular mass and its deviation from theoretical (typically ±1 Da) are reported. The spectrum is included in the CoA.

An endotoxin test using the Limulus Amebocyte Lysate (LAL) method is performed on every batch. Specification: < 5 EU/mg for in vitro research use and compatible preclinical models.

Residual water content is determined by Karl Fischer titration. Specification: < 6% by weight. This ensures lyophilizate stability during transport and ambient storage for up to 30 days.

Through acid hydrolysis and derivatization, the theoretical amino acid composition of the peptide is confirmed. This detects substitutions, incomplete sequences, and synthesis by-products that HPLC might not resolve.

On request, we coordinate cross-validation by an accredited independent analytical laboratory. Cost and lead times are quoted separately. We will publish the names of cooperating laboratories once formal agreements are in place.