AX-2025-019120 · Vilon · GSP lot GSP-2411-J3700

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, 15 min gradient, 214 nm	99.78	% area	≥ 99.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.22	% area	≤ 1.0	PASS
Largest single impurity	RP-HPLC — free lysine (−129 Da)	0.10	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	275.1481	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, unit resolution (single quadrupole)	275.1493	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+4.5	ppm	± 20	PASS
Total peptide content	by difference from the gravimetric mass balance	75.61	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	75.44	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	13.41	mg	10 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	10.117	mg	10 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	101.2	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	5.79	%	≤ 12.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	17.99	%	≤ 10.0	FAIL
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.61	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	0.39	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 cake, partial shrinkage from vial wall	—	white to off-white intact cake	FAIL
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	5.46	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 15 min gradient	2.15	min	2.13 ± 0.20 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.19	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	73,234	—	≥ 20,000	PASS
Resolution to nearest impurity	vs diketopiperazine (−18 Da)	1.53	—	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 73,234, and skew follows the reported asymmetry factor of 1.19. 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 0.10 % impurity against a 99.78 % 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	2.15	4,849,617	99.78	—
2	free lysine (−129 Da)	2.03	4,860	0.10	-129.043
3	Lys-Glu-Lys tripeptide (+128 Da)	2.22	2,916	0.06	+128.095
4	diketopiperazine (−18 Da)	2.20	2,916	0.06	-18.011
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, unit-resolution instrument. Sticks are placed at m/z = (M + z × 1.007276)/z for the observed neutral mass of 275.1493 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	276.1566	0.0012	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	5.79
Counter-ion (acetate)	ion chromatography	17.99
Residual solvent + inorganic residue	estimated	0.61
Total peptide content	by difference	75.61
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)	99.40	99.78	divergence +0.11 pp vs batch median
Total impurities (% area)	0.60	0.22
Largest single impurity (% area)	not stated	0.10
Water (%)	5.1	5.79
Counter-ion (%)	7.5	17.99
Peptide content (%w/w)	86.8	75.61
Endotoxin (EU/mg)	not stated	0.39
Method stated on certificate	NO	—	no method section — the result cannot be reconciled against any other

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, 28 d) → laboratory (courier, cold pack, 8 d) → assay.
Assay date: 18 Jan 2025
Submitted to the index: 09 Feb 2025
Laboratory: Kestrel Bioanalytical, Melbourne, Australia
Method basis: 15 min gradient · unit-resolution MS
Verification status: METHOD LIMITED

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.
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.

c18_2p609 Feb 2025

Column chemistry flatters or punishes a figure like this. A core-shell column at this gradient resolves the close-eluting family that a fully porous 5 µm bed merges, so 99.78 % here is a harder number than the same figure from a coarser column.

quarter_over_quarter09 Feb 2025

Single records do not establish trends. Where this supplier's quarterly medians are stable across four quarters, a result like this reads as the process rather than the draw — and the timeline page is where to check that.

ms_confirm09 Feb 2025

+4.5 ppm at this mass is a clean identity confirmation. With retention at 2.15 min, Vilon is established as the species measured. Note what it does not exclude: a mass-identical diastereomer, which no mass measurement of any resolution can.

Section 7

Related records

Same batch — lot GSP-2411-J3700 n=4

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-019118	GSP-2411-J3700	Janoshik	2025-Q1	98.88	5.60	—	Buyer-sourced	0	FAIL
AX-2025-019119	GSP-2411-J3700	Janoshik	2025-Q1	99.36	6.24	89.5	Buyer-sourced	1	FAIL
AX-2025-019121	GSP-2411-J3700	Medutest	2025-Q1	99.21	5.52	105.6	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-2025-021141	SIG	SIG-2505-6919	Nordanalyt	2025-Q4	98.38	7.50	—	Buyer-sourced	0	FAIL
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

Other recent GSP records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041831	Survodutide	GSP-2603-E3156	Kestrel	2026-Q3	99.91	5.50	93.2	Buyer-sourced	0	PASS
AX-2026-041836	Survodutide	GSP-2603-E3156	Janoshik	2026-Q3	98.65	5.34	90.3	Buyer-sourced	0	PASS
AX-2026-041837	Survodutide	GSP-2603-E3156	Janoshik	2026-Q3	98.33	5.37	—	Buyer-sourced	0	PASS
AX-2026-041833	Survodutide	GSP-2603-E3156	Janoshik	2026-Q3	98.08	4.91	99.3	Buyer-sourced	0	PASS
AX-2026-041832	Survodutide	GSP-2603-E3156	VendorInvestigate	2026-Q3	98.01	5.14	99.5	Buyer-sourced	0	PASS
AX-2026-041835	Survodutide	GSP-2603-E3156	Nordanalyt	2026-Q3	98.34	5.74	89.0	Buyer-sourced	1	MARGINAL
AX-2026-041834	Survodutide	GSP-2603-E3156	VendorInvestigate	2026-Q3	97.92	5.95	—	Buyer-sourced	0	PASS
AX-2026-041838	Survodutide	GSP-2603-E3156	PeptideMeter	2026-Q3	98.30	5.01	102.4	Buyer-sourced	0	PASS