| Batch | Date | Purity (HPLC) | Impurities | Water | Endotoxin | Microbial | Status | Certificate |
|---|---|---|---|---|---|---|---|---|
| BH-V-391-2025-04-A | 04 Apr 2025 | 99.53% | 0.38% | 0.65% | < 0.1 EU/mg | < 10 CFU/g | PASSED | REQUEST |
| BH-V-203-2024-11-B | 11 Nov 2024 | 99.48% | 0.42% | 0.70% | < 0.1 EU/mg | < 10 CFU/g | PASSED | REQUEST |
| BH-V-087-2024-06-C | 06 Jun 2024 | 99.44% | 0.45% | 0.73% | < 0.1 EU/mg | < 10 CFU/g | PASSED | REQUEST |
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.