TB-500
Certificate of Analysis · Lot PL-26087 · 5 mg
HPLC purity · 220 nm
Test results
6/6 conform| Test | Method | Specification | Result | |
|---|---|---|---|---|
| Appearance | Visual | White to almost white lyophilisate | White lyophilisate | |
| Identity | ESI-MS | Conforms to theoretical mass (± 0.5 Da) | Conforms | |
| Purity | RP-HPLC 220 nm | ≥ 98.0 % | 98.87 % | |
| Largest single impurity | RP-HPLC 220 nm | ≤ 1.0 % | 0.61 % | |
| Water content | Karl Fischer | ≤ 8.0 % | 5.2 % | |
| Acetate content | Ion chromatography | ≤ 15.0 % | 11.3 % |
Chromatogram
Peaks assigned by LC-MSRP-HPLC · 220 nmMain peak tR 8.60 min
Mass spectrometry
ESI positive| Ion | Theoretical (m/z) | Found (m/z) | Δ (Da) |
|---|---|---|---|
| [M+H]+ | 889.50 | 889.49 | -0.01 |
| [M+2H]2+ | 445.25 | 445.25 | 0.00 |
Methodology
As for batch PL-26091 (RP-HPLC C18, 0.1 % TFA, gradient 5 to 65 % B over 20 min, 220 nm; ESI-MS positive mode).
Remarks
Deamidation of the glutamine at the C-terminus is a known degradation pathway and, at 0.32 %, was within specification. Batch released.
Sample report illustrating the report structure. Before market launch all reports will be replaced by test protocols from the accredited laboratory.