Every batch is independently verified at our Lausanne reference lab. Identity by HPLC-MS, purity by HPLC-UV at 220 nm, and endotoxin by USP <85> LAL kinetic chromogenic assay.
HPLC-MS confirmation against certified reference standard. Molecular mass within ±0.5 Da of theoretical.
HPLC-UV at 220 nm, gradient elution. Acceptance ≥99.0%. Related impurities sum < 1.0%.
USP <85> LAL kinetic chromogenic. Acceptance < 0.5 EU/mg per USP General Chapter.
USP <61>/<62> — total aerobic count, yeasts and moulds, absence of specified organisms.