AX-2025-020708 · GHK-Cu · GL Biochem lot GLBI-2502-L8987

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, 30 min gradient, 214 nm	97.59	% area	≥ 97.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	2.41	% area	≤ 3.0	PASS
Largest single impurity	RP-HPLC — Gly-His dipeptide (−128 Da)	1.31	% area	≤ 1.00	FAIL
Identity — theoretical monoisotopic mass	calculated from molecular formula	401.1024	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, high resolution (ESI-TOF/QTOF)	401.1020	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	-1.0	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	95.54	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	93.24	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	111.75	mg	100 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	104.196	mg	100 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	104.2	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	3.94	%	≤ 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/	0.52	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	8.85	EU/mg	≤ 5.0	FAIL
Sterility	not ordered on this submission	not determined	—	no growth	NOT TESTED
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	Faint haze, clearing on standing	—	clear, no visible particulates	FAIL
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	6.97	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	6.01	min	6.18 ± 0.25 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.28	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	74,561	—	≥ 20,000	PASS
Resolution to nearest impurity	vs oxidised His (+16 Da)	2.66	—	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, 30 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 74,561, and skew follows the reported asymmetry factor of 1.28. 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 1.31 % impurity against a 97.59 % 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	6.01	4,743,177	97.59	—
2	Gly-His dipeptide (−128 Da)	5.31	63,670	1.31	-128.095
3	apo-GHK (copper-free, −62 Da)	5.53	27,218	0.56	-61.930
4	oxidised His (+16 Da)	5.77	17,497	0.36	+15.995
5	GHK-Cu 2:1 complex	6.63	8,749	0.18	+277.145
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, high-resolution instrument. Sticks are placed at m/z = (M + z × 1.007276)/z for the observed neutral mass of 401.1020 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	402.1093	-0.0004	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	3.94
Counter-ion	none expected	0.00
Residual solvent + inorganic residue	estimated	0.52
Total peptide content	by difference	95.54
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)	96.90	97.59	divergence -0.37 pp vs batch median
Total impurities (% area)	2.64	2.41
Largest single impurity (% area)	not stated	1.31
Water (%)	not stated	3.94
Counter-ion (%)	8.5	N/A
Peptide content (%w/w)	87.4	95.54
Endotoxin (EU/mg)	not stated	8.85
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: Supplier-supplied
Evidentiary weight: Weaker evidence. Read with the caveat below.
Chain of custody: Supplier despatch → laboratory direct (courier, cold pack, 5 d) → assay. Submitter did not handle the vial.
Assay date: 14 Sep 2025
Submitted to the index: 20 Sep 2025
Laboratory: Janoshik Analytical, Ostrava, Czechia
Method basis: 30 min gradient · high-resolution MS
Verification status: PARTIAL

What this report does not establish

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 5

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.

lal_assay20 Sep 2025

8.85 EU/mg is above the index screening threshold of 5.0. Two things to keep separate: the index threshold is a screening figure, and a real limit is dose-dependent. The endotoxin dose-limit calculator does that arithmetic. What this record establishes is that the burden is measurable and high relative to the rest of the dataset.

endotoxin_limit20 Sep 2025

Endotoxin burden at this level usually tracks water quality at the fill step rather than anything about the synthesis. A high-purity lot with high endotoxin is an entirely coherent result and this is one.

esi_tof20 Sep 2025

Endotoxin determined but the LAL method is not stated. Kinetic chromogenic and gel-clot give different results and different sensitivity. The value cannot be interpreted without knowing which.

thin_coverage20 Sep 2025

8.85 EU/mg but the material was passed through a sterile sterile filter. Some filters leach endotoxins; the measurement does not distinguish material from filter contribution.

sodium_adduct20 Sep 2025

Endotoxin tested twice on this lot with varying EU/mg spread. Endotoxin variability in retained samples is larger than most labs acknowledge and the single measurement here is not definitive.

Section 7

Related records

Same batch — lot GLBI-2502-L8987 n=5

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-020704	GLBI-2502-L8987	Janoshik	2025-Q3	97.36	4.00	—	Supplier-supplied	2	FAIL
AX-2025-020705	GLBI-2502-L8987	Janoshik	2025-Q3	97.27	3.72	—	Supplier-supplied	1	MARGINAL
AX-2025-020706	GLBI-2502-L8987	Janoshik	2025-Q3	96.80	3.46	—	Buyer-sourced	1	FAIL
AX-2025-020707	GLBI-2502-L8987	Janoshik	2025-Q3	96.68	4.27	102.4	Buyer-sourced	1	FAIL

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-2026-043144	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-2026-042571	ERP	ERP-2604-K8139	Medutest	2026-Q2	99.25	6.66	104.4	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

Other recent GL Biochem records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043176	Kisspeptin-10	GLBI-2608-N8085	Medutest	2026-Q3	98.22	3.30	92.5	Buyer-sourced	2	FAIL
AX-2026-043180	Kisspeptin-10	GLBI-2608-N8085	Janoshik	2026-Q3	98.69	3.37	103.8	Supplier-supplied	2	MARGINAL
AX-2026-043178	Kisspeptin-10	GLBI-2608-N8085	Janoshik	2026-Q3	98.24	4.44	96.0	Supplier-supplied	2	FAIL
AX-2026-043177	Kisspeptin-10	GLBI-2608-N8085	Janoshik	2026-Q3	98.31	3.87	106.5	Buyer-sourced	2	FAIL
AX-2026-043202	Semaglutide	GLBI-2602-U8631	PeptideMeter	2026-Q3	96.77	6.38	89.7	Supplier-supplied	3	FAIL
AX-2026-043174	Kisspeptin-10	GLBI-2608-N8085	Medutest	2026-Q3	98.18	4.09	—	Laboratory-retained	2	FAIL
AX-2026-043201	Semaglutide	GLBI-2602-U8631	Janoshik	2026-Q3	96.91	5.77	91.2	Supplier-supplied	2	FAIL
AX-2026-043203	Semaglutide	GLBI-2602-U8631	Medutest	2026-Q3	97.45	6.09	—	Supplier-supplied	2	MARGINAL