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Certificates of Analysis

Batch-specific analytical documentation including HPLC purity chromatograms, LC-MS identity confirmation, endotoxin screening, and heavy metals analysis. All testing performed by independent accredited laboratories.

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Analytical Methods

HPLC Purity Analysis

Reverse-phase C18 column chromatography with UV detection at 220nm. Gradient elution with acetonitrile/water mobile phase. Purity calculated as percentage of main peak area relative to total integrated area.

LC-MS Identity Confirmation

Electrospray ionization mass spectrometry (ESI-MS) in positive ion mode. Molecular identity confirmed by matching observed [M+H]⁺ m/z values to theoretical molecular weight within ±0.1% tolerance.

Contaminant Screening

Endotoxin testing via Limulus Amebocyte Lysate (LAL) kinetic turbidimetric method. Heavy metals screening by inductively coupled plasma mass spectrometry (ICP-MS) per USP <232>/<233>.