AX-2025-019119 · 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, 30 min gradient, 214 nm	99.36	% area	≥ 99.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.64	% area	≤ 1.0	PASS
Largest single impurity	RP-HPLC — diketopiperazine (−18 Da)	0.39	% 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)	275.1484	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+1.1	ppm	± 20	PASS
Total peptide content	by difference from the gravimetric mass balance	81.78	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	81.26	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	11.01	mg	10 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	8.947	mg	10 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	89.5	%	90.0 – 110.0	FAIL
Water content	Karl Fischer, coulometric, duplicate	6.24	%	≤ 12.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	11.35	%	≤ 10.0	FAIL
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.63	%	—	NOT TESTED
Endotoxin	not ordered on this submission	not determined	—	≤ 5.0	NOT TESTED
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	6.05	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	4.00	min	3.94 ± 0.20 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	0.89	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	69,734	—	≥ 20,000	PASS
Resolution to nearest impurity	vs diketopiperazine (−18 Da)	1.61	—	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 69,734, and skew follows the reported asymmetry factor of 0.89. 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 0.39 % impurity against a 99.36 % 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	4.00	4,829,204	99.36	—
2	diketopiperazine (−18 Da)	4.10	18,955	0.39	-18.011
3	Lys-Glu-Lys tripeptide (+128 Da)	4.14	8,263	0.17	+128.095
4	free glutamic acid (−128 Da)	3.70	1,944	0.04	-128.095
5	free lysine (−129 Da)	3.76	1,944	0.04	-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 275.1484 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	276.1557	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.

Component	Determination	%w/w of cake
Water	Karl Fischer	6.24
Counter-ion (acetate)	ion chromatography	11.35
Residual solvent + inorganic residue	estimated	0.63
Total peptide content	by difference	81.78
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	99.36	divergence +0.11 pp vs batch median
Total impurities (% area)	0.60	0.64
Largest single impurity (% area)	not stated	0.39
Water (%)	5.1	6.24
Counter-ion (%)	7.5	11.35
Peptide content (%w/w)	86.8	81.78
Endotoxin (EU/mg)	not stated	not determined
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, 9 d) → laboratory (courier, cold pack, 11 d) → assay.
Assay date: 25 Mar 2025
Submitted to the index: 13 Apr 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 free of bacterial endotoxin. Endotoxin was not measured. No chromatographic result bears on it.
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 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_21413 Apr 2025

Detection wavelength does not affect a mass determination but it does affect the purity figure sitting next to it. Both are stated on this record, which is the point.

desiccant_note13 Apr 2025

The packaging as received is part of the evidence on a retail purchase. Whether a desiccant was in the box is a fact about ordinary shipments, not about sample shipments.

aaa_hydrolysis13 Apr 2025

Amino-acid analysis gives peptide content on a salt-free basis directly, which sidesteps the counter-ion question rather than answering it. Both numbers are useful and they answer different questions.

counterion_mol13 Apr 2025

Hydrochloride, acetate and trifluoroacetate differ in formula weight by more than a factor of two. The same molar loading produces very different percentages and comparing percentages across salt forms is meaningless.

Section 7

Related records

Same batch — lot GSP-2411-J3700 n=4

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2025-019118	GSP-2411-J3700	Janoshik	2025-Q1	98.88	5.60	—	Buyer-sourced	FAIL
AX-2025-019120	GSP-2411-J3700	Kestrel	2025-Q1	99.78	5.79	101.2	Buyer-sourced	FAIL
AX-2025-019121	GSP-2411-J3700	Medutest	2025-Q1	99.21	5.52	105.6	Buyer-sourced	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