AssayIndex

AX-2026-042551

GHK-Cu · 50 mg declared · Shanghai ERP Biotechnology Co., Ltd. · lot ERP-2601-F7633

PASSIDENTITY CONSISTENT
Report ID
AX-2026-042551
Compound
GHK-Cu
Compound class
Tissue-repair and immunomodulatory peptides
Supplier
ERP — Shanghai ERP Biotechnology Co., Ltd.
Batch / lot
ERP-2601-F7633
Declared label claim
50mg
Laboratory
Nordanalyt Laboratories
Assay date
19 Jun 2026
Submitted
20 Jun 2026
Quarter
2026-Q2
Submitter
ha.hartmann
Sample provenance
Laboratory-retained
Section 1

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.

ParameterMethodResultUnitIndex spec
PurityRP-HPLC, 35 min gradient, 214 nm98.41% area≥ 97.0PASS
Total impuritiesRP-HPLC, sum of reported peaks1.59% area≤ 3.0PASS
Largest single impurityRP-HPLC — GHK-Cu 2:1 complex0.67% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula401.1024DaNOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)401.1022DaNOT TESTED
Mass accuracyobserved vs theoretical-0.4ppm± 15PASS
Peptide contentnot ordered on this submissionnot determinedrequired to check label claimNOT TESTED
Water contentKarl Fischer, coulometric, duplicate4.50%≤ 10.0PASS
Counter-ionno ionisable counter-ion expectedN/Anot applicableNOT TESTED
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.85%NOT TESTED
Endotoxinnot ordered on this submissionnot determined≤ 5.0NOT TESTED
Sterilitynot ordered on this submissionnot determinedno growthNOT TESTED
Appearancevisual, diffuse light, black and white backgroundWhite lyophilised cake, intactwhite to off-white intact cakePASS
Reconstitution clarityreconstituted per submitter procedureClear, colourless, no visible particulatesclear, no visible particulatesPASS
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration7.512.5 – 8.0PASS
Retention time (observed)RP-HPLC, 35 min gradient7.03min7.13 ± 0.25 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.100.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²58,040≥ 20,000PASS
Resolution to nearest impurityvs oxidised His (+16 Da)2.34no index criterionREPORTED
Section 2

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.

0371874361115414872 GHK-Cu7.03 min · 98.41 % 6.47 same trace · ×100 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 0510152025303540 Retention time (min) Response (mAU)
Figure 1. RP-HPLC trace, 35 min gradient, 214 nm. Drawn from the peak-integration table below: peak positions are the reported retention times, peak areas are the reported area percentages, peak widths follow the reported plate count of 58,040, and skew follows the reported asymmetry factor of 1.10. Baseline noise is seeded from the report ID and is illustrative. The lower panel is the same trace at a stated vertical expansion with the slow gradient drift subtracted, because at full scale a 0.67 % impurity against a 98.41 % main peak is a line two pixels tall; the main peak runs off-scale there by design.
#PeakRTArea (µV·s)% areaΔ mass (Da)
1GHK-Cu — main peak7.034,783,03198.41
2GHK-Cu 2:1 complex7.7532,5640.67+277.145
3apo-GHK (copper-free, −62 Da)6.4728,1900.58-61.930
4Gly-His dipeptide (−128 Da)6.2110,2070.21-128.095
5oxidised His (+16 Da)6.756,3180.13+15.995
Closure check — purity + Σ impurities 100.00CLOSES

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.

Section 3

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.

0255075100350375400425450475 [M+1H]1+402.11 m/z Relative abundance (%)
Figure 2. ESI charge-state envelope, high-resolution instrument. Sticks are placed at m/z = (M + z × 1.007276)/z for the observed neutral mass of 401.1022 Da. Sodium (+21.982/z) and potassium (+37.956/z) adducts are shown where the parent charge state exceeds 25 % relative abundance; they are adducts of the same molecule and are not impurities.
ChargeTheoretical m/zObserved m/zΔ m/zRel. abundance (%)
1+402.1097402.1095-0.0002100.0
Section 4

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.

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.

FigureSupplier COAThis reportIndex note
Purity (% area)99.1298.41divergence +0.59 pp vs batch median
Total impurities (% area)not stated1.59
Largest single impurity (% area)not stated0.67
Water (%)1.94.50
Counter-ion (%)4.7N/A
Peptide content (%w/w)92.8not determined
Endotoxin (EU/mg)not statednot determined
Method stated on certificateYEScolumn, gradient and wavelength given
Section 5

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
Laboratory-retained
Evidentiary weight
Provenance documented, selection uncontrolled.
Chain of custody
Laboratory retained sample (−20 °C, 7 d since original receipt) → re-assay.
Assay date
19 Jun 2026
Submitted to the index
20 Jun 2026
Laboratory
Nordanalyt Laboratories, Uppsala, Sweden
Method basis
35 min gradient · high-resolution MS
Verification status
IDENTITY CONSISTENT
Section 6

Annotations

No annotations on this record. Annotations are short signed technical comments from index contributors; see how to contribute.

Section 7

Related records

Same batch — lot ERP-2601-F7633 n=9

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042550ERP-2601-F7633Janoshik2026-Q298.534.43Supplier-supplied1MARGINAL
AX-2026-042552ERP-2601-F7633Kestrel2026-Q298.394.13Supplier-supplied0PASS
AX-2026-042553ERP-2601-F7633Janoshik2026-Q298.544.20Supplier-supplied0PASS
AX-2026-042554ERP-2601-F7633Janoshik2026-Q298.454.56Supplier-supplied0PASS
AX-2026-042555ERP-2601-F7633Medutest2026-Q298.873.93Supplier-supplied0PASS
AX-2026-042556ERP-2601-F7633PeptideMeter2026-Q298.844.48Supplier-supplied0PASS
AX-2026-042557ERP-2601-F7633Kestrel2026-Q298.864.4395.4Supplier-supplied0PASS
AX-2026-042558ERP-2601-F7633PeptideMeter2026-Q298.234.09104.0Supplier-supplied0PASS
Other recent GHK-Cu records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043144SSASSA-2604-V7620Janoshik2026-Q298.355.25105.8Supplier-supplied0PASS
AX-2026-042550ERPERP-2601-F7633Janoshik2026-Q298.534.43Supplier-supplied1MARGINAL
AX-2026-042571ERPERP-2604-K8139Medutest2026-Q299.256.66104.4Supplier-supplied1MARGINAL
AX-2026-042552ERPERP-2601-F7633Kestrel2026-Q298.394.13Supplier-supplied0PASS
AX-2026-041251WWBWWB-2512-B1996PeptideMeter2026-Q299.566.16Supplier-supplied0PASS
AX-2026-041247WWBWWB-2512-B1996PeptideMeter2026-Q299.935.95104.8Supplier-supplied0PASS
AX-2026-043205SGNSGN-2603-X9044Janoshik2026-Q297.534.6898.0Supplier-supplied0PASS
AX-2026-041250WWBWWB-2512-B1996Janoshik2026-Q299.436.14Supplier-supplied0PASS
Other recent ERP records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042574TB-500ERP-2605-S8022VendorInvestigate2026-Q399.542.9196.4Buyer-sourced1MARGINAL
AX-2026-042535TesamorelinERP-2604-W7280Janoshik2026-Q399.193.8992.7Supplier-supplied1MARGINAL
AX-2026-042577TB-500ERP-2605-S8022Janoshik2026-Q399.513.45Supplier-supplied1MARGINAL
AX-2026-042542TesamorelinERP-2604-W7280Janoshik2026-Q398.544.58103.1Supplier-supplied2FAIL
AX-2026-042547SurvodutideERP-2605-E7682PeptideMeter2026-Q398.255.4493.0Supplier-supplied1MARGINAL
AX-2026-042540TesamorelinERP-2604-W7280Kestrel2026-Q399.723.47103.2Supplier-supplied1MARGINAL
AX-2026-042575TB-500ERP-2605-S8022Janoshik2026-Q399.933.3695.5Supplier-supplied0PASS
AX-2026-042539TesamorelinERP-2604-W7280Janoshik2026-Q398.774.3089.9Buyer-sourced2MARGINAL