AX-2025-021141 · Vilon · SIG lot SIG-2505-6919

Section 1

Results

Measured against the index acceptance specification for the short bioregulator 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, 35 min gradient, 214 nm	98.38	% area	≥ 99.0	FAIL
Total impurities	RP-HPLC, sum of reported peaks	1.62	% area	≤ 1.0	FAIL
Largest single impurity	RP-HPLC — free glutamic acid (−128 Da)	0.82	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	275.1481	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, high resolution (ESI-TOF/QTOF)	275.1478	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	-1.2	ppm	± 20	PASS
Peptide content	not ordered on this submission	not determined	—	required to check label claim	NOT TESTED
Water content	Karl Fischer, coulometric, duplicate	7.50	%	≤ 12.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	16.04	%	≤ 10.0	FAIL
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.42	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	0.36	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	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	4.74	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 35 min gradient	4.70	min	4.54 ± 0.20 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	0.97	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	58,815	—	≥ 20,000	PASS
Resolution to nearest impurity	vs diketopiperazine (−18 Da)	1.47	—	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, 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 58,815, and skew follows the reported asymmetry factor of 0.97. 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 0.82 % impurity against a 98.38 % 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	Vilon — main peak	4.70	4,781,573	98.38	—
2	free glutamic acid (−128 Da)	4.35	39,855	0.82	-128.095
3	diketopiperazine (−18 Da)	4.82	16,039	0.33	-18.011
4	Lys-Glu-Lys tripeptide (+128 Da)	4.86	12,151	0.25	+128.095
5	free lysine (−129 Da)	4.42	10,693	0.22	-129.043
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 275.1481 Da, computed from C11H21N3O5. 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 275.1478 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+	276.1554	276.1551	-0.0003	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.

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)	98.01	98.38	divergence -0.27 pp vs batch median
Total impurities (% area)	1.99	1.62
Largest single impurity (% area)	not stated	0.82
Water (%)	not stated	7.50
Counter-ion (%)	not stated	16.04
Peptide content (%w/w)	not stated	not determined
Endotoxin (EU/mg)	0.30	0.36
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: Retail purchase → submitter (ambient, 29 d) → laboratory (hand-carried, 10 d) → assay.
Assay date: 11 Nov 2025
Submitted to the index: 22 Nov 2025
Laboratory: Nordanalyt Laboratories, Uppsala, Sweden
Method basis: 35 min gradient · high-resolution MS
Verification status: VERIFIED

What this report does not establish

How much of the named compound is in the vial. Peptide content was not determined, so recovered mass cannot be calculated and the label claim cannot be checked.
That the material is sterile. Sterility was not tested.
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 3

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.

lipidation_step22 Nov 2025

On an acylated compound the mono-ester by-product of the side-chain step is the impurity that most often carries a result into this band, and it is regiochemistry rather than sloppiness. The named table above will say whether that is what happened here.

storage_stated22 Nov 2025

Stated storage conditions on the certificate against the observed transit conditions in the custody block: on this record they agree, which removes one class of explanation for anything unexpected.

dedupe_logic22 Nov 2025

Two retail purchases of the same lot from different buyers are genuinely independent. Two aliquots of one purchase are not, and the index does not treat them as such.

Section 7

Related records

Same batch — lot SIG-2505-6919 n=2

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-021140	SIG-2505-6919	VendorInvestigate	2025-Q4	98.17	7.72	—	Buyer-sourced	0	FAIL

Batch rollup and reproducibility assessment →

Cross-sections

Other recent Vilon records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-021140	SIG	SIG-2505-6919	VendorInvestigate	2025-Q4	98.17	7.72	—	Buyer-sourced	0	FAIL
AX-2025-020540	SSA	SSA-2508-B6436	Janoshik	2025-Q3	99.13	5.93	97.9	Buyer-sourced	1	FAIL
AX-2025-019010	ASY	ASY-{CAT}-1626	Medutest	2025-Q3	99.93	8.57	89.9	Supplier-supplied	1	FAIL
AX-2025-019016	ASY	ASY-{CAT}-1626	Medutest	2025-Q3	99.93	8.37	99.2	Buyer-sourced	1	FAIL
AX-2025-019012	ASY	ASY-{CAT}-1626	Janoshik	2025-Q3	99.93	8.26	—	Buyer-sourced	0	FAIL
AX-2025-020541	SSA	SSA-2508-B6436	Kestrel	2025-Q3	99.15	6.21	93.5	Buyer-sourced	0	FAIL
AX-2025-019017	ASY	ASY-{CAT}-1626	Janoshik	2025-Q3	99.86	8.52	—	Buyer-sourced	0	FAIL
AX-2025-019013	ASY	ASY-{CAT}-1626	Janoshik	2025-Q3	99.93	8.92	96.3	Buyer-sourced	0	FAIL

Other recent SIG records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043535	GHRP-2	SIG-2603-6031	Janoshik	2026-Q3	99.12	1.26	105.7	Buyer-sourced	0	PASS
AX-2026-043541	GHRP-2	SIG-2603-6031	PeptideMeter	2026-Q3	99.06	2.08	107.4	Buyer-sourced	1	MARGINAL
AX-2026-043539	GHRP-2	SIG-2603-6031	Janoshik	2026-Q3	98.95	1.74	100.4	Buyer-sourced	1	FAIL
AX-2026-043534	GHRP-2	SIG-2603-6031	Medutest	2026-Q3	99.11	2.15	89.8	Buyer-sourced	1	MARGINAL
AX-2026-043542	GHRP-2	SIG-2603-6031	VendorInvestigate	2026-Q3	99.05	1.43	—	Buyer-sourced	1	FAIL
AX-2026-043543	GHRP-2	SIG-2603-6031	Janoshik	2026-Q3	99.38	1.70	98.6	Buyer-sourced	0	PASS
AX-2026-043544	GHRP-2	SIG-2603-6031	PeptideMeter	2026-Q3	99.57	1.51	105.4	Buyer-sourced	0	PASS
AX-2026-043538	GHRP-2	SIG-2603-6031	Kestrel	2026-Q3	98.93	1.72	—	Buyer-sourced	0	FAIL