AX-2025-019011 · Vilon · ASY lot ASY-{CAT}-1626

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, 25 min gradient, 214 nm	99.93	% area	≥ 99.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.07	% area	≤ 1.0	PASS
Largest single impurity	RP-HPLC — free lysine (−129 Da)	0.04	% 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)	275.1529	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+17.6	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	8.97	%	≤ 12.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	17.96	%	≤ 10.0	FAIL
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.47	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	7.54	EU/mg	≤ 5.0	FAIL
Sterility	membrane filtration, USP <71>, 14 d	No growth at 14 d	—	no growth	PASS
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	4.66	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 25 min gradient	3.39	min	3.34 ± 0.20 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.13	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	86,802	—	≥ 20,000	PASS
Resolution to nearest impurity	vs free lysine (−129 Da)	4.24	—	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, 25 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 86,802, and skew follows the reported asymmetry factor of 1.13. 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 0.04 % impurity against a 99.93 % 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	3.39	4,856,908	99.93	—
2	free lysine (−129 Da)	3.19	1,944	0.04	-129.043
3	free glutamic acid (−128 Da)	3.14	1,458	0.03	-128.095
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 275.1529 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	276.1602	0.0048	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)	99.78	99.93	divergence -0.15 pp vs batch median
Total impurities (% area)	0.22	0.07
Largest single impurity (% area)	0.14	0.04
Water (%)	6.8	8.97
Counter-ion (%)	5.2	17.96
Peptide content (%w/w)	87.4	not determined
Endotoxin (EU/mg)	not stated	7.54
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, 1 d) → laboratory (courier, cold pack, 12 d) → assay.
Assay date: 05 Jul 2025
Submitted to the index: 12 Jul 2025
Laboratory: Medutest, Ljubljana, Slovenia
Method basis: 25 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.
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 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.

lambda_21412 Jul 2025

99.93 % 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.

racemisation_ala12 Jul 2025

Epimerisation during activation produces a diastereomer that is mass-identical and only chromatographically separable. At this gradient length the separation exists, and 99.93 % is net of it.

fill_homogeneity12 Jul 2025

One retail vial is one draw from a fill. Two or three from the same lot would separate fill variation from lot quality, and that is the cheapest useful experiment in this whole field.

counterion_mol12 Jul 2025

Stoichiometry per basic residue is arithmetic anybody can do from the sequence, and it converts a counter-ion percentage from a number into a check. Very few people do it.

Section 7

Related records

Same batch — lot ASY-{CAT}-1626 n=8

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-019010	ASY-{CAT}-1626	Medutest	2025-Q3	99.93	8.57	89.9	Supplier-supplied	1	FAIL
AX-2025-019012	ASY-{CAT}-1626	Janoshik	2025-Q3	99.93	8.26	—	Buyer-sourced	0	FAIL
AX-2025-019013	ASY-{CAT}-1626	Janoshik	2025-Q3	99.93	8.92	96.3	Buyer-sourced	0	FAIL
AX-2025-019014	ASY-{CAT}-1626	VendorInvestigate	2025-Q3	99.65	8.56	92.7	Laboratory-retained	0	FAIL
AX-2025-019015	ASY-{CAT}-1626	Nordanalyt	2025-Q3	99.93	8.64	—	Buyer-sourced	0	FAIL
AX-2025-019016	ASY-{CAT}-1626	Medutest	2025-Q3	99.93	8.37	99.2	Buyer-sourced	1	FAIL
AX-2025-019017	ASY-{CAT}-1626	Janoshik	2025-Q3	99.86	8.52	—	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 ASY records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041776	TB-500	ASY-{CAT}-2167	Janoshik	2026-Q3	99.92	4.61	98.2	Buyer-sourced	0	PASS
AX-2026-041777	TB-500	ASY-{CAT}-2167	PeptideMeter	2026-Q3	99.78	4.09	92.8	Buyer-sourced	0	PASS
AX-2026-041786	Retatrutide	ASY-{CAT}-2288	VendorInvestigate	2026-Q3	98.78	6.59	—	Buyer-sourced	0	PASS
AX-2026-041782	TB-500	ASY-{CAT}-2167	Nordanalyt	2026-Q3	99.93	3.94	—	Buyer-sourced	0	PASS
AX-2026-041793	Retatrutide	ASY-{CAT}-2288	Nordanalyt	2026-Q3	98.34	6.16	104.8	Buyer-sourced	0	PASS
AX-2026-041784	Retatrutide	ASY-{CAT}-2288	PeptideMeter	2026-Q3	98.15	6.26	91.9	Buyer-sourced	0	PASS
AX-2026-041774	TB-500	ASY-{CAT}-2167	PeptideMeter	2026-Q3	99.93	4.41	96.2	Buyer-sourced	0	PASS
AX-2026-041780	TB-500	ASY-{CAT}-2167	Janoshik	2026-Q3	99.93	3.48	102.5	Buyer-sourced	1	FAIL