AX-2026-043209
GHK-Cu · 200 mg declared · Sangon Biotech (Shanghai) Co., Ltd. · lot SGN-2603-X8452
- Report ID
- AX-2026-043209
- Compound
- GHK-Cu
- Compound class
- Tissue-repair and immunomodulatory peptides
- Supplier
- SGN — Sangon Biotech (Shanghai) Co., Ltd.
- Batch / lot
- SGN-2603-X8452
- Declared label claim
- 200mg
- Laboratory
- PeptideMeter
- Assay date
- 19 May 2026
- Submitted
- 20 May 2026
- Quarter
- 2026-Q2
- Submitter
- r.nilsen
- Sample provenance
- Buyer-sourced
Results
Measured against the index acceptance specification for the tissue-repair and immunomodulatory peptides class. A specification is a decision the index made; a result is a measurement. See where each threshold came from.
| Parameter | Method | Result | Unit | Index spec | |
|---|---|---|---|---|---|
| Purity | RP-HPLC, 28 min gradient, 214 nm | 98.17 | % area | ≥ 97.0 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 1.83 | % area | ≤ 3.0 | PASS |
| Largest single impurity | RP-HPLC — Gly-His dipeptide (−128 Da) | 0.85 | % area | ≤ 1.00 | PASS |
| Identity — theoretical monoisotopic mass | calculated from molecular formula | 401.1024 | Da | — | NOT TESTED |
| Identity — observed monoisotopic mass | LC-MS, high resolution (ESI-TOF/QTOF) | 401.1016 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | -1.9 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 95.29 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 93.55 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 207.45 | mg | 200 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 194.069 | mg | 200 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 97.0 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 3.93 | % | ≤ 10.0 | PASS |
| Counter-ion | no ionisable counter-ion expected | N/A | — | not applicable | NOT TESTED |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.78 | % | — | NOT TESTED |
| Endotoxin | kinetic chromogenic LAL | 0.32 | EU/mg | ≤ 5.0 | PASS |
| Sterility | membrane filtration, USP <71>, 14 d | No growth at 14 d | — | no growth | PASS |
| Appearance | visual, diffuse light, black and white background | White lyophilised cake, intact | — | white to off-white intact cake | PASS |
| Reconstitution clarity | reconstituted per submitter procedure | Clear, colourless, no visible particulates | — | clear, no visible particulates | PASS |
| pH (reconstituted, 1 mg/mL) | potentiometric, two-point calibration | 7.07 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 28 min gradient | 5.95 | min | 5.80 ± 0.25 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.05 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 45,305 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs oxidised His (+16 Da) | 1.95 | — | no index criterion | REPORTED |
Chromatogram and peak integration
The figure is drawn from the table. It is not an independent illustration — if a number in the table changed, the trace would change with it.
| # | Peak | RT | Area (µV·s) | % area | Δ mass (Da) |
|---|---|---|---|---|---|
| 1 | GHK-Cu — main peak | 5.95 | 4,771,366 | 98.17 | — |
| 2 | Gly-His dipeptide (−128 Da) | 5.30 | 41,313 | 0.85 | -128.095 |
| 3 | apo-GHK (copper-free, −62 Da) | 5.50 | 21,871 | 0.45 | -61.930 |
| 4 | GHK-Cu 2:1 complex | 6.53 | 13,123 | 0.27 | +277.145 |
| 5 | oxidised His (+16 Da) | 5.73 | 12,637 | 0.26 | +15.995 |
| Closure check — purity + Σ impurities | 100.00 | CLOSES | |||
Reporting threshold 0.05 % area. Peaks below it are not reported and are therefore excluded from the total, which overstates purity by their sum — see peak integration.
Mass spectrum and identity
Theoretical monoisotopic mass 401.1024 Da, computed from C14H22CuN6O4. All ppm figures on this site are against monoisotopic values — see why that matters.
| Charge | Theoretical m/z | Observed m/z | Δ m/z | Rel. abundance (%) |
|---|---|---|---|---|
| 1+ | 402.1097 | 402.1089 | -0.0008 | 100.0 |
Gravimetric mass balance
Water, counter-ion, residual and total peptide content are exhaustive and mutually exclusive categories. They must account for 100 % of the cake mass. The index closes this to within 0.02 pp and the build asserts it.
| Component | Determination | %w/w of cake |
|---|---|---|
| Water | Karl Fischer | 3.93 |
| Counter-ion | none expected | 0.00 |
| Residual solvent + inorganic residue | estimated | 0.78 |
| Total peptide content | by difference | 95.29 |
| Total | 100.00 CLOSES | |
Supplier certificate, as declared
The supplier's own figures for this lot, beside the independent measurement. Divergence is assessed against the batch median, not against this single report — see rule AX-R05.
| Figure | Supplier COA | This report | Index note |
|---|---|---|---|
| Purity (% area) | 98.23 | 98.17 | divergence +0.01 pp vs batch median |
| Total impurities (% area) | 1.77 | 1.83 | |
| Largest single impurity (% area) | not stated | 0.85 | |
| Water (%) | 2.1 | 3.93 | |
| Counter-ion (%) | 4.3 | N/A | |
| Peptide content (%w/w) | 93.0 | 95.29 | |
| Endotoxin (EU/mg) | 0.29 | 0.32 | |
| Method stated on certificate | NO | — | no method section — the result cannot be reconciled against any other |
Provenance and caveats
Where a sample came from changes the weight of the evidence. The index treats it as a first-class field.
- Sample provenance
- Buyer-sourced
- Evidentiary weight
- Strongest available evidence in this index.
- Chain of custody
- Retail purchase → submitter (ambient, 10 d) → laboratory (hand-carried, 9 d) → assay.
- Assay date
- 19 May 2026
- Submitted to the index
- 20 May 2026
- Laboratory
- PeptideMeter, Tallinn, Estonia
- Method basis
- 28 min gradient · high-resolution MS
- Verification status
- PARTIAL
Annotations
No annotations on this record. Annotations are short signed technical comments from index contributors; see how to contribute.
Related records
Same batch — lot SGN-2603-X8452 n=12
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043201 | SGN-2603-X8452 | Janoshik | 2026-Q2 | 98.04 | 4.07 | 106.2 | Buyer-sourced | 0 | PASS |
| AX-2026-043202 | SGN-2603-X8452 | Medutest | 2026-Q2 | 97.97 | 3.65 | — | Buyer-sourced | 0 | PASS |
| AX-2026-043203 | SGN-2603-X8452 | Medutest | 2026-Q2 | 98.53 | 3.88 | — | Buyer-sourced | 0 | PASS |
| AX-2026-043204 | SGN-2603-X8452 | Janoshik | 2026-Q2 | 97.76 | 3.77 | — | Laboratory-retained | 0 | PASS |
| AX-2026-043205 | SGN-2603-X8452 | PeptideMeter | 2026-Q2 | 98.93 | 4.03 | — | Supplier-supplied | 0 | PASS |
| AX-2026-043206 | SGN-2603-X8452 | Kestrel | 2026-Q2 | 98.27 | 3.55 | 95.9 | Buyer-sourced | 0 | PASS |
| AX-2026-043207 | SGN-2603-X8452 | PeptideMeter | 2026-Q2 | 98.16 | 3.89 | 91.6 | Buyer-sourced | 0 | PASS |
| AX-2026-043208 | SGN-2603-X8452 | Janoshik | 2026-Q2 | 98.34 | 3.44 | — | Buyer-sourced | 0 | PASS |
| AX-2026-043210 | SGN-2603-X8452 | Janoshik | 2026-Q2 | 97.84 | 4.28 | — | Buyer-sourced | 0 | PASS |
| AX-2026-043211 | SGN-2603-X8452 | Janoshik | 2026-Q2 | 98.88 | 3.97 | 98.0 | Supplier-supplied | 0 | PASS |
| AX-2026-043212 | SGN-2603-X8452 | Janoshik | 2026-Q2 | 98.69 | 3.57 | — | Supplier-supplied | 1 | FAIL |
Cross-sections
- All GHK-Cu records n=72
- All SGN records n=221
- All PeptideMeter records n=1116
- All 2026-Q2 records n=1126
- GHK-Cu by supplier
- GHK-Cu impurity profile
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043160 | SSA | SSA-2604-V7731 | Janoshik | 2026-Q2 | 98.01 | 4.02 | 91.8 | Buyer-sourced | 0 | PASS |
| AX-2026-043157 | SSA | SSA-2604-V7731 | Medutest | 2026-Q2 | 99.19 | 5.14 | — | Supplier-supplied | 0 | PASS |
| AX-2026-041251 | WWB | WWB-2512-B1996 | PeptideMeter | 2026-Q2 | 99.43 | 5.87 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043249 | CPC | CPC-2601-D1258 | Kestrel | 2026-Q2 | 99.50 | 6.96 | — | Supplier-supplied | 0 | PASS |
| AX-2026-043245 | CPC | CPC-2601-D1258 | PeptideMeter | 2026-Q2 | 98.10 | 6.57 | 95.0 | Supplier-supplied | 0 | PASS |
| AX-2026-041247 | WWB | WWB-2512-B1996 | PeptideMeter | 2026-Q2 | 99.23 | 6.09 | 88.8 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-042708 | ERP | ERP-2601-F9816 | Nordanalyt | 2026-Q2 | 98.88 | 3.87 | 91.5 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043154 | SSA | SSA-2604-V7731 | PeptideMeter | 2026-Q2 | 97.82 | 4.82 | 101.6 | Buyer-sourced | 0 | PASS |
| Report | Compound | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043233 | Afamelanotide | SGN-2602-Y9306 | Janoshik | 2026-Q3 | 98.76 | 4.02 | 92.2 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043234 | Afamelanotide | SGN-2602-Y9306 | Kestrel | 2026-Q3 | 99.93 | 4.16 | — | Buyer-sourced | 0 | PASS |
| AX-2026-043240 | SLU-PP-332 | SGN-2602-X9377 | Janoshik | 2026-Q2 | 98.82 | 5.46 | 97.0 | Buyer-sourced | 0 | PASS |
| AX-2026-043222 | ARA-290 | SGN-2605-X9069 | PeptideMeter | 2026-Q2 | 98.32 | 7.36 | — | Buyer-sourced | 0 | PASS |
| AX-2026-043237 | SLU-PP-332 | SGN-2602-X9377 | Janoshik | 2026-Q2 | 98.47 | 6.22 | 100.0 | Supplier-supplied | 0 | PASS |
| AX-2026-043227 | ARA-290 | SGN-2605-X9069 | PeptideMeter | 2026-Q2 | 98.38 | 7.21 | 95.6 | Buyer-sourced | 0 | PASS |
| AX-2026-043239 | SLU-PP-332 | SGN-2602-X9377 | VendorInvestigate | 2026-Q2 | 98.28 | 5.37 | — | Buyer-sourced | 0 | PASS |
| AX-2026-043229 | ARA-290 | SGN-2605-X9069 | Janoshik | 2026-Q2 | 98.21 | 7.43 | — | Buyer-sourced | 0 | PASS |