AX-2024-004699 · GHK-Cu · Homopeptide lot HOMO-2408-C3445

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.

Parameter	Method	Result	Unit	Index spec
Purity	RP-HPLC, 15 min gradient, 214 nm	99.67	% area	≥ 97.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.33	% area	≤ 3.0	PASS
Largest single impurity	RP-HPLC — oxidised His (+16 Da)	0.18	% 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)	401.1127	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+25.8	ppm	± 15	FAIL
Total peptide content	by difference from the gravimetric mass balance	94.13	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	93.82	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	108.73	mg	100 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	102.010	mg	100 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	102.0	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	5.41	%	≤ 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/	0.46	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	0.42	EU/mg	≤ 5.0	PASS
Sterility	not ordered on this submission	not determined	—	no growth	NOT TESTED
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	6.65	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 15 min gradient	3.37	min	3.34 ± 0.25 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.14	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	53,861	—	≥ 20,000	PASS
Resolution to nearest impurity	vs oxidised His (+16 Da)	2.02	—	no index criterion	REPORTED

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.

Figure 1. RP-HPLC trace, 15 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 53,861, and skew follows the reported asymmetry factor of 1.14. 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 0.18 % impurity against a 99.67 % main peak is a line two pixels tall; the main peak runs off-scale there by design.

#	Peak	RT	Area (µV·s)	% area	Δ mass (Da)
1	GHK-Cu — main peak	3.37	4,844,271	99.67	—
2	oxidised His (+16 Da)	3.25	8,749	0.18	+15.995
3	GHK-Cu 2:1 complex	3.68	4,860	0.10	+277.145
4	Gly-His dipeptide (−128 Da)	3.02	1,458	0.03	-128.095
5	apo-GHK (copper-free, −62 Da)	3.13	972	0.02	-61.930
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.

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.

Figure 2. ESI charge-state envelope, unit-resolution instrument. Sticks are placed at m/z = (M + z × 1.007276)/z for the observed neutral mass of 401.1127 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.

Charge	Theoretical m/z	Observed m/z	Δ m/z	Rel. abundance (%)
1+	402.1097	402.1200	0.0103	100.0

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.

Component	Determination	%w/w of cake
Water	Karl Fischer	5.41
Counter-ion	none expected	0.00
Residual solvent + inorganic residue	estimated	0.46
Total peptide content	by difference	94.13
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)	98.60	99.67	divergence -0.50 pp vs batch median
Total impurities (% area)	not stated	0.33
Largest single impurity (% area)	not stated	0.18
Water (%)	5.0	5.41
Counter-ion (%)	8.9	N/A
Peptide content (%w/w)	85.5	94.13
Endotoxin (EU/mg)	not stated	0.42
Method stated on certificate	YES	—	column, 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: Buyer-sourced
Evidentiary weight: Strongest available evidence in this index.
Chain of custody: Domestic warehouse despatch → submitter (2–8 °C, 30 d) → laboratory (courier, cold pack, 12 d) → assay.
Assay date: 09 Sep 2024
Submitted to the index: 01 Oct 2024
Laboratory: Kestrel Bioanalytical, Melbourne, Australia
Method basis: 15 min gradient · unit-resolution MS
Verification status: PARTIAL

What this report does not establish

That the compound is not a near-isobaric alternative. Identity was confirmed at unit mass resolution, which cannot exclude species differing by 1 or 2 Da. The specific alternatives not excluded are named in the identity block above.
That the material is sterile. Sterility was not tested.
How much metal is present. The mobile phase dissociates the complex on-column, so the peptide was measured and the metal was not. A purity figure for a metal-complexed peptide without a separate metal determination is half of a result.
That any other vial in the same lot has the same composition. One vial was tested. Within-lot vial-to-vial variation in this index has a median of 0.28 pp and a 90th percentile of 0.74 pp.
That any other lot from the same supplier has the same composition. Batch-to-batch variation is larger than within-batch variation for every supplier here.
That the material is suitable for administration to a human or an animal. These are research compounds. No result on this site is a safety assessment and the index takes no position on use.
That the material was manufactured by the supplier that sold it. Contract synthesis is normal in this market and twenty-nine batches in the index fingerprint to a bulk from a different company than the one named on the label.

Section 6

Annotations 4

Signed technical comments from index contributors. Not a discussion forum — annotations question or contextualise the result, and the data team replies where a reply is warranted.

ms_confirm01 Oct 2024

99.67 % is normalised area, so it is silent on how much peptide is in the vial. Content and water are the numbers that answer that, and both are on this record. Purity is the good news; content is the actionable news.

diode_array01 Oct 2024

Photodiode-array spectral homogeneity across the main peak would convert 99.67 % from a good number into a checked one. It is a free measurement on any instrument that already has the detector.

chain_custody01 Oct 2024

A retail vial at 99.67 % is worth more evidentially than a selected vial at a higher figure. That is the whole argument for recording provenance at all.

sample_vs_retail01 Oct 2024

Where a supplier-supplied result on the same lot also exists, the pair is the informative object rather than either record alone. The batch page shows whether one does.

Section 7

Related records

Same batch — lot HOMO-2408-C3445 n=13

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2024-004693	HOMO-2408-C3445	Janoshik	2024-Q3	99.15	5.33	102.2	Buyer-sourced	0	PASS
AX-2024-004694	HOMO-2408-C3445	Janoshik	2024-Q3	99.19	5.69	—	Buyer-sourced	0	PASS
AX-2024-004695	HOMO-2408-C3445	Medutest	2024-Q3	99.16	5.34	96.0	Buyer-sourced	0	PASS
AX-2024-004696	HOMO-2408-C3445	VendorInvestigate	2024-Q3	99.10	5.30	104.2	Buyer-sourced	0	PASS
AX-2024-004697	HOMO-2408-C3445	Janoshik	2024-Q3	98.93	4.85	102.8	Buyer-sourced	0	PASS
AX-2024-004698	HOMO-2408-C3445	VendorInvestigate	2024-Q3	99.10	5.65	—	Buyer-sourced	0	PASS
AX-2024-004700	HOMO-2408-C3445	VendorInvestigate	2024-Q3	98.87	5.35	99.5	Buyer-sourced	0	PASS
AX-2024-004701	HOMO-2408-C3445	Janoshik	2024-Q3	98.83	5.02	88.7	Buyer-sourced	1	MARGINAL
AX-2024-004702	HOMO-2408-C3445	Janoshik	2024-Q3	98.75	5.79	—	Buyer-sourced	1	FAIL
AX-2024-004703	HOMO-2408-C3445	Medutest	2024-Q3	99.19	4.91	—	Buyer-sourced	0	PASS
AX-2024-004704	HOMO-2408-C3445	PeptideMeter	2024-Q3	99.07	5.04	—	Supplier-supplied	0	PASS
AX-2024-004705	HOMO-2408-C3445	Janoshik	2024-Q3	99.05	4.87	—	Buyer-sourced	0	PASS

Batch rollup and reproducibility assessment →

Cross-sections

Other recent GHK-Cu records in the index.
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

Other recent Homopeptide records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2026-042437	Retatrutide	HOMO-2605-V4718	Nordanalyt	2026-Q3	98.68	3.67	102.8	Buyer-sourced	PASS
AX-2026-042424	Semaglutide	HOMO-2604-X3806	PeptideMeter	2026-Q3	98.85	4.87	92.0	Buyer-sourced	PASS
AX-2026-042503	IGF-1 LR3	HOMO-2607-P5131	Janoshik	2026-Q3	99.36	5.99	—	Buyer-sourced	PASS
AX-2026-042492	SS-31 (Elamipretide)	HOMO-2604-D5484	Medutest	2026-Q3	99.93	2.40	—	Buyer-sourced	PASS
AX-2026-042491	SS-31 (Elamipretide)	HOMO-2604-D5484	Kestrel	2026-Q3	99.93	3.24	—	Supplier-supplied	PASS
AX-2026-042473	LL-37	HOMO-2602-G5165	Janoshik	2026-Q3	99.01	5.00	—	Buyer-sourced	PASS
AX-2026-042441	Retatrutide	HOMO-2605-V4718	Medutest	2026-Q3	98.93	4.22	—	Buyer-sourced	PASS
AX-2026-042474	LL-37	HOMO-2602-G5165	Janoshik	2026-Q3	99.18	5.44	—	Buyer-sourced	PASS