AX-2026-042571
GHK-Cu · 200 mg declared · Shanghai ERP Biotechnology Co., Ltd. · lot ERP-2604-K8139
- Report ID
- AX-2026-042571
- Compound
- GHK-Cu
- Compound class
- Tissue-repair and immunomodulatory peptides
- Supplier
- ERP — Shanghai ERP Biotechnology Co., Ltd.
- Batch / lot
- ERP-2604-K8139
- Declared label claim
- 200mg
- Laboratory
- Medutest
- Assay date
- 23 Jun 2026
- Submitted
- 06 Jul 2026
- Quarter
- 2026-Q2
- Submitter
- fr.villalobos
- Sample provenance
- Supplier-supplied
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, 25 min gradient, 214 nm | 99.25 | % area | ≥ 97.0 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 0.75 | % area | ≤ 3.0 | PASS |
| Largest single impurity | RP-HPLC — GHK-Cu 2:1 complex | 0.51 | % area | ≤ 1.00 | PASS |
| Identity — theoretical monoisotopic mass | calculated from molecular formula | 401.1024 | Da | — | NOT TESTED |
| Identity — observed monoisotopic mass | LC-MS, unit resolution (single quadrupole) | 401.1008 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | -4.0 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 92.79 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 92.09 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 226.80 | mg | 200 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 208.860 | mg | 200 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 104.4 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 6.66 | % | ≤ 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/ | 0.55 | % | — | NOT TESTED |
| Endotoxin | kinetic chromogenic LAL | 0.15 | 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 | Off-white lyophilised cake, intact | — | white to off-white intact cake | PASS |
| Reconstitution clarity | reconstituted per submitter procedure | Clear with a single visible fibre | — | clear, no visible particulates | FAIL |
| pH (reconstituted, 1 mg/mL) | potentiometric, two-point calibration | 6.10 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 25 min gradient | 5.19 | min | 5.23 ± 0.25 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.08 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 56,567 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs oxidised His (+16 Da) | 2.24 | — | 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 | 5.19 | 4,823,858 | 99.25 | — |
| 2 | GHK-Cu 2:1 complex | 5.71 | 24,788 | 0.51 | +277.145 |
| 3 | Gly-His dipeptide (−128 Da) | 4.61 | 7,776 | 0.16 | -128.095 |
| 4 | apo-GHK (copper-free, −62 Da) | 4.79 | 2,916 | 0.06 | -61.930 |
| 5 | oxidised His (+16 Da) | 4.99 | 972 | 0.02 | +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 | 402.1081 | -0.0016 | 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 | 6.66 |
| Counter-ion | none expected | 0.00 |
| Residual solvent + inorganic residue | estimated | 0.55 |
| Total peptide content | by difference | 92.79 |
| 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) | 99.18 | 99.25 | divergence +0.84 pp vs batch median |
| Total impurities (% area) | 0.82 | 0.75 | |
| Largest single impurity (% area) | 0.57 | 0.51 | |
| Water (%) | 5.1 | 6.66 | |
| Counter-ion (%) | 5.0 | N/A | |
| Peptide content (%w/w) | 98.1 | 92.79 | |
| Endotoxin (EU/mg) | not stated | 0.15 | |
| Method stated on certificate | YES | — | column, gradient and wavelength given |
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
- Supplier-supplied
- Evidentiary weight
- Weaker evidence. Read with the caveat below.
- Chain of custody
- Supplier despatch → laboratory direct (courier, cold pack, 8 d) → assay. Submitter did not handle the vial.
- Assay date
- 23 Jun 2026
- Submitted to the index
- 06 Jul 2026
- Laboratory
- Medutest, Ljubljana, Slovenia
- Method basis
- 25 min gradient · unit-resolution MS
- Verification status
- IDENTITY CONSISTENT
Annotations
No annotations on this record. Annotations are short signed technical comments from index contributors; see how to contribute.
Related records
Same batch — lot ERP-2604-K8139 n=3
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042569 | ERP-2604-K8139 | Medutest | 2026-Q2 | 98.34 | 6.96 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042570 | ERP-2604-K8139 | Janoshik | 2026-Q2 | 98.02 | 6.43 | 96.6 | Supplier-supplied | 1 | MARGINAL |
Cross-sections
- All GHK-Cu records n=41
- All ERP records n=247
- All Medutest records n=940
- All 2026-Q2 records n=1009
- GHK-Cu by supplier
- GHK-Cu impurity profile
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043144 | SSA | SSA-2604-V7620 | Janoshik | 2026-Q2 | 98.35 | 5.25 | 105.8 | Supplier-supplied | 0 | PASS |
| AX-2026-042550 | ERP | ERP-2601-F7633 | Janoshik | 2026-Q2 | 98.53 | 4.43 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042552 | ERP | ERP-2601-F7633 | Kestrel | 2026-Q2 | 98.39 | 4.13 | — | Supplier-supplied | 0 | PASS |
| AX-2026-041251 | WWB | WWB-2512-B1996 | PeptideMeter | 2026-Q2 | 99.56 | 6.16 | — | Supplier-supplied | 0 | PASS |
| AX-2026-041247 | WWB | WWB-2512-B1996 | PeptideMeter | 2026-Q2 | 99.93 | 5.95 | 104.8 | Supplier-supplied | 0 | PASS |
| AX-2026-043205 | SGN | SGN-2603-X9044 | Janoshik | 2026-Q2 | 97.53 | 4.68 | 98.0 | Supplier-supplied | 0 | PASS |
| AX-2026-041250 | WWB | WWB-2512-B1996 | Janoshik | 2026-Q2 | 99.43 | 6.14 | — | Supplier-supplied | 0 | PASS |
| AX-2026-042551 | ERP | ERP-2601-F7633 | Nordanalyt | 2026-Q2 | 98.41 | 4.50 | — | Laboratory-retained | 0 | PASS |
| Report | Compound | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042574 | TB-500 | ERP-2605-S8022 | VendorInvestigate | 2026-Q3 | 99.54 | 2.91 | 96.4 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-042535 | Tesamorelin | ERP-2604-W7280 | Janoshik | 2026-Q3 | 99.19 | 3.89 | 92.7 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042577 | TB-500 | ERP-2605-S8022 | Janoshik | 2026-Q3 | 99.51 | 3.45 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042542 | Tesamorelin | ERP-2604-W7280 | Janoshik | 2026-Q3 | 98.54 | 4.58 | 103.1 | Supplier-supplied | 2 | FAIL |
| AX-2026-042547 | Survodutide | ERP-2605-E7682 | PeptideMeter | 2026-Q3 | 98.25 | 5.44 | 93.0 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042540 | Tesamorelin | ERP-2604-W7280 | Kestrel | 2026-Q3 | 99.72 | 3.47 | 103.2 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042575 | TB-500 | ERP-2605-S8022 | Janoshik | 2026-Q3 | 99.93 | 3.36 | 95.5 | Supplier-supplied | 0 | PASS |
| AX-2026-042539 | Tesamorelin | ERP-2604-W7280 | Janoshik | 2026-Q3 | 98.77 | 4.30 | 89.9 | Buyer-sourced | 2 | MARGINAL |