AX-2025-020540

Vilon · 10 mg declared · Shanghai Sigma-Audley New Material Technology Co., Ltd. · lot SSA-2508-B6436

FAILMETHOD LIMITED

Report ID: AX-2025-020540
Compound: Vilon
Compound class: Short bioregulator peptides
Supplier: SSA — Shanghai Sigma-Audley New Material Technology Co., Ltd.
Batch / lot: SSA-2508-B6436
Declared label claim: 10mg
Laboratory: Janoshik Analytical
Assay date: 17 Sep 2025
Submitted: 29 Sep 2025
Quarter: 2025-Q3
Submitter: l.falk
Sample provenance: Buyer-sourced

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, 30 min gradient, 214 nm	99.13	% area	≥ 99.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.87	% area	≤ 1.0	PASS
Largest single impurity	RP-HPLC — free glutamic acid (−128 Da)	0.54	% 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)	275.1469	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	-4.3	ppm	± 20	PASS
Total peptide content	by difference from the gravimetric mass balance	78.48	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	77.80	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	12.58	mg	10 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	9.787	mg	10 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	97.9	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	5.93	%	≤ 12.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	15.12	%	≤ 10.0	FAIL
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.47	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	0.89	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	Faint haze, clearing on standing	—	clear, no visible particulates	FAIL
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	6.08	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	4.51	min	3.94 ± 0.20 (normalised)	FAIL
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	0.86	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	76,583	—	≥ 20,000	PASS
Resolution to nearest impurity	vs diketopiperazine (−18 Da)	1.50	—	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 76,583, and skew follows the reported asymmetry factor of 0.86. 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 0.54 % impurity against a 99.13 % 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	4.51	4,818,025	99.13	—
2	free glutamic acid (−128 Da)	4.21	26,246	0.54	-128.095
3	Lys-Glu-Lys tripeptide (+128 Da)	4.65	6,804	0.14	+128.095
4	diketopiperazine (−18 Da)	4.61	5,346	0.11	-18.011
5	free lysine (−129 Da)	4.27	3,888	0.08	-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 275.1469 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	276.1542	-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	5.93
Counter-ion (acetate)	ion chromatography	15.12
Residual solvent + inorganic residue	estimated	0.47
Total peptide content	by difference	78.48
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)	99.51	99.13	divergence +0.36 pp vs batch median
Total impurities (% area)	0.49	0.87
Largest single impurity (% area)	0.27	0.54
Water (%)	3.8	5.93
Counter-ion (%)	8.3	15.12
Peptide content (%w/w)	87.3	78.48
Endotoxin (EU/mg)	0.58	0.89
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, 3 d) → laboratory (courier, cold pack, 5 d) → assay.
Assay date: 17 Sep 2025
Submitted to the index: 29 Sep 2025
Laboratory: Janoshik Analytical, Ostrava, Czechia
Method basis: 30 min gradient · high-resolution MS
Verification status: METHOD LIMITED

What this report does not establish

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.

schema_v229 Sep 2025

Both the theoretical and the observed monoisotopic mass are in the published dataset, so the ppm figure can be re-derived rather than trusted. That is the intent of publishing both.

peak_integrator29 Sep 2025

Resolution to the nearest named impurity is reported on this record with no verdict attached, which is the correct handling. A threshold on that figure would penalise compounds for their own impurity profiles.

sec_monomer29 Sep 2025

Where the close neighbour is an aggregate rather than a related substance, size exclusion separates them trivially and reverse phase never will.

Section 7

Related records

Same batch — lot SSA-2508-B6436 n=3

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-020539	SSA-2508-B6436	Nordanalyt	2025-Q3	99.26	5.49	—	Buyer-sourced	0	FAIL
AX-2025-020541	SSA-2508-B6436	Kestrel	2025-Q3	99.15	6.21	93.5	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-2025-019010	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 SSA records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043135	BPC-157	SSA-2601-N6863	Nordanalyt	2026-Q2	98.16	4.66	92.8	Buyer-sourced	1	MARGINAL
AX-2026-043160	GHK-Cu	SSA-2604-V7731	Janoshik	2026-Q2	98.01	4.02	91.8	Buyer-sourced	0	PASS
AX-2026-043157	GHK-Cu	SSA-2604-V7731	Medutest	2026-Q2	99.19	5.14	—	Supplier-supplied	0	PASS
AX-2026-043141	BPC-157	SSA-2601-N6863	Janoshik	2026-Q2	98.06	4.06	94.6	Buyer-sourced	1	MARGINAL
AX-2026-043154	GHK-Cu	SSA-2604-V7731	PeptideMeter	2026-Q2	97.82	4.82	101.6	Buyer-sourced	0	PASS
AX-2026-043137	BPC-157	SSA-2601-N6863	PeptideMeter	2026-Q2	98.17	4.14	—	Buyer-sourced	1	MARGINAL
AX-2026-043162	GHK-Cu	SSA-2604-V7731	Janoshik	2026-Q2	98.50	4.36	—	Supplier-supplied	0	PASS
AX-2026-043134	BPC-157	SSA-2601-N6863	Medutest	2026-Q2	97.89	4.01	—	Buyer-sourced	1	FAIL