Batch GL-2608-187
Issued 14 July 2026
| Product name | Peak Glow™ — 30-day pen |
| Presentation | Lyophilised powder, multi-dose pen cartridge |
| Batch / lot number | GL-2608-187 |
| Manufacture date | 2026-06-28 |
| Retest date | 2028-06-28 |
| Storage | 2–8 °C after reconstitution · protect from light |
| Active | Declared / pen | Assayed | Result |
|---|---|---|---|
| Active | 100mg | 100.2 mg | Pass |
| Active | 10mg | 10.1 mg | Pass |
| Active | 10mg | 10.0 mg | Pass |
| Active | 50mg | 49.8 mg | Pass |
| Test | Method | Specification | Result |
|---|---|---|---|
| Appearance | Visual | White lyophilised cake | Conforms Pass |
| Purity | RP-HPLC, 214 nm | ≥ 98.0 % | 99.8 % Pass |
| Identity | ESI-MS | Conforms to theoretical | Conforms Pass |
| Water content | Karl Fischer | ≤ 8.0 % | 3.1 % Pass |
| Bacterial endotoxin | LAL kinetic | < 0.20 EU/mg | < 0.05 EU/mg Pass |
| Residual TFA | Ion chromatography | ≤ 1.0 % | 0.28 % Pass |
| Heavy metals | ICP-MS | Within limits | Conforms Pass |
| Microbial limits | Plate count | < 100 CFU/g | < 10 CFU/g Pass |
| Column | C18, 4.6 × 250 mm, 5 µm |
| Mobile phase A | 0.1 % TFA in water |
| Mobile phase B | 0.1 % TFA in acetonitrile |
| Gradient | 5 → 65 % B over 20 min |
| Detection | UV 214 nm |