BPC-157
Certificate of Analysis · Lot PL-26091 · 10 mg
HPLC purity · 220 nm
Test results
8/8 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 % | 99.31 % | |
| Largest single impurity | RP-HPLC 220 nm | ≤ 1.0 % | 0.34 % | |
| Peptide content | Elemental analysis (N) | ≥ 80.0 % | 84.6 % | |
| Water content | Karl Fischer | ≤ 8.0 % | 4.1 % | |
| Acetate content | Ion chromatography | ≤ 15.0 % | 9.8 % | |
| Solubility | Visual in water | Clear and colourless | Clear and colourless |
Chromatogram
Peaks assigned by LC-MSRP-HPLC · 220 nmMain peak tR 11.20 min
Mass spectrometry
ESI positive| Ion | Theoretical (m/z) | Found (m/z) | Δ (Da) |
|---|---|---|---|
| [M+H]+ | 1419.71 | 1419.69 | -0.02 |
| [M+2H]2+ | 710.36 | 710.35 | -0.01 |
| [M+3H]3+ | 473.91 | 473.91 | 0.00 |
Methodology
RP-HPLC: C18 column 4.6 × 250 mm, 5 µm. Eluent A: 0.1 % TFA in water, eluent B: 0.1 % TFA in acetonitrile. Gradient 5 to 65 % B over 20 min, 1.0 ml/min, 30 °C, detection at 220 nm. Purity as area percent.
ESI-MS: electrospray, positive mode, direct infusion in 50 % acetonitrile with 0.1 % formic acid. Deconvolution of charge states.
Remarks
The three minor peaks were assigned by LC-MS. No single peak above 1.0 %. Batch released.
Sample report illustrating the report structure. Before market launch all reports will be replaced by test protocols from the accredited laboratory.