| Batch | Date | Purity (HPLC) | Impurities | Water | Endotoxin | Microbial | Status | Certificate |
|---|---|---|---|---|---|---|---|---|
| BH-V-833-2025-02-A | 19 Feb 2025 | 99.62% | 0.32% | 0.58% | < 0.1 EU/mg | < 10 CFU/g | PASSED | REQUEST |
| BH-V-562-2024-10-B | 11 Oct 2024 | 99.57% | 0.36% | 0.63% | < 0.1 EU/mg | < 10 CFU/g | PASSED | REQUEST |
| BH-V-347-2024-05-C | 08 May 2024 | 99.53% | 0.39% | 0.65% | < 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.