AssayIndex

AX-2026-042470

Epitalon · 10 mg declared · Hunan Aslsen Technology Co., Ltd. · lot HOMO-2512-A5108

FAILMETHOD LIMITED
Report ID
AX-2026-042470
Compound
Epitalon
Compound class
Short bioregulator peptides
Supplier
Homopeptide — Hunan Aslsen Technology Co., Ltd.
Batch / lot
HOMO-2512-A5108
Declared label claim
10mg
Laboratory
Janoshik Analytical
Assay date
11 Jun 2026
Submitted
25 Jun 2026
Quarter
2026-Q2
Submitter
c.adeyemi
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.

ParameterMethodResultUnitIndex spec
PurityRP-HPLC, 30 min gradient, 214 nm99.63% area≥ 99.0PASS
Total impuritiesRP-HPLC, sum of reported peaks0.37% area≤ 1.0PASS
Largest single impurityRP-HPLC — aspartimide (−18 Da)0.18% area≤ 1.00PASS
Identitynot ordered on this submissionnot determinedrequired for VERIFIED statusNOT TESTED
Peptide contentnot ordered on this submissionnot determinedrequired to check label claimNOT TESTED
Water contentKarl Fischer, coulometric, duplicate7.99%≤ 12.0PASS
Counter-ion (acetate)anion-exchange ion chromatography14.67%≤ 10.0FAIL
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.17%NOT TESTED
Endotoxinkinetic chromogenic LAL0.21EU/mg≤ 5.0PASS
Sterilitymembrane filtration, USP <71>, 14 dNo growth at 14 dno growthPASS
Appearancevisual, diffuse light, black and white backgroundWhite cake, partial shrinkage from vial wallwhite to off-white intact cakeFAIL
Reconstitution clarityreconstituted per submitter procedureVisible particulates, did not clearclear, no visible particulatesFAIL
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration5.412.5 – 8.0PASS
Retention time (observed)RP-HPLC, 30 min gradient4.51min4.62 ± 0.20 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.120.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²54,845≥ 20,000PASS
Resolution to nearest impurityvs β-Asp isomer1.27no index criterionREPORTED
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.

05650112991694922599 Epitalon4.51 min · 99.63 % 4.63 same trace · ×200 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 05101520253035 Retention time (min) Response (mAU)
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 54,845, and skew follows the reported asymmetry factor of 1.12. 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 0.18 % impurity against a 99.63 % main peak is a line two pixels tall; the main peak runs off-scale there by design.
#PeakRTArea (µV·s)% areaΔ mass (Da)
1Epitalon — main peak4.514,842,32799.63
2aspartimide (−18 Da)4.638,7490.18-18.011
3Ala-Glu-Asp tripeptide (−57 Da)4.314,8600.10-57.021
4β-Asp isomer4.412,4300.050.000
5diketopiperazine (−18 Da)4.671,9440.04-18.011
Closure check — purity + Σ impurities 100.00CLOSES

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 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.

FigureSupplier COAThis reportIndex note
Purity (% area)99.4199.63divergence -0.52 pp vs batch median
Total impurities (% area)not stated0.37
Largest single impurity (% area)not stated0.18
Water (%)5.87.99
Counter-ion (%)not stated14.67
Peptide content (%w/w)not statednot determined
Endotoxin (EU/mg)0.210.21
Method stated on certificateYEScolumn, 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, 15 d) → laboratory (courier, cold pack, 6 d) → assay.
Assay date
11 Jun 2026
Submitted to the index
25 Jun 2026
Laboratory
Janoshik Analytical, Ostrava, Czechia
Method basis
30 min gradient · high-resolution MS
Verification status
METHOD LIMITED
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.

Alkylation artefacts from a scavenger-poor cleavage would appear as a +58 or +76 family here. Absent, which says the cleavage was run properly.
buyer_sourced
Anyone can generate one of these. That is the argument the index makes on its submission page and it is the reason the dataset grows without any supplier's cooperation.
peak_integrator
Anyone comparing this purity figure against a result from a longer method should expect a difference of a few tenths in a predictable direction. The inter-lab page quantifies it per laboratory.
Section 7

Related records

Same batch — lot HOMO-2512-A5108 n=10

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042462HOMO-2512-A5108Kestrel2026-Q299.938.02Buyer-sourced0PASS
AX-2026-042463HOMO-2512-A5108Janoshik2026-Q299.937.6893.2Buyer-sourced0FAIL
AX-2026-042464HOMO-2512-A5108Medutest2026-Q299.938.12102.0Buyer-sourced1MARGINAL
AX-2026-042465HOMO-2512-A5108Medutest2026-Q299.898.0496.0Buyer-sourced0FAIL
AX-2026-042466HOMO-2512-A5108Medutest2026-Q299.717.99Buyer-sourced0FAIL
AX-2026-042467HOMO-2512-A5108Janoshik2026-Q299.937.81Buyer-sourced0FAIL
AX-2026-042468HOMO-2512-A5108Janoshik2026-Q299.937.81100.8Buyer-sourced0PASS
AX-2026-042469HOMO-2512-A5108Janoshik2026-Q299.938.3093.7Buyer-sourced0FAIL
AX-2026-042471HOMO-2512-A5108VendorInvestigate2026-Q299.398.0490.0Buyer-sourced0PASS
Other recent Epitalon records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042008AMBAMB-2602-Y6433Janoshik2026-Q399.308.75105.1Buyer-sourced0PASS
AX-2026-042009AMBAMB-2602-Y6433VendorInvestigate2026-Q399.168.62102.3Buyer-sourced0FAIL
AX-2026-042010AMBAMB-2602-Y6433Janoshik2026-Q399.098.20103.4Laboratory-retained0FAIL
AX-2026-042007AMBAMB-2602-Y6433Janoshik2026-Q399.428.6293.8Buyer-sourced0FAIL
AX-2026-042468HomopeptideHOMO-2512-A5108Janoshik2026-Q299.937.81100.8Buyer-sourced0PASS
AX-2026-042463HomopeptideHOMO-2512-A5108Janoshik2026-Q299.937.6893.2Buyer-sourced0FAIL
AX-2026-042041HYBHYB-2603-U7133Janoshik2026-Q299.656.8295.3Buyer-sourced0FAIL
AX-2026-042040HYBHYB-2603-U7133Janoshik2026-Q299.746.36Buyer-sourced0FAIL
Other recent Homopeptide records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042437RetatrutideHOMO-2605-V4718Nordanalyt2026-Q398.683.67102.8Buyer-sourced0PASS
AX-2026-042424SemaglutideHOMO-2604-X3806PeptideMeter2026-Q398.854.8792.0Buyer-sourced0PASS
AX-2026-042503IGF-1 LR3HOMO-2607-P5131Janoshik2026-Q399.365.99Buyer-sourced0PASS
AX-2026-042492SS-31 (Elamipretide)HOMO-2604-D5484Medutest2026-Q399.932.40Buyer-sourced0PASS
AX-2026-042491SS-31 (Elamipretide)HOMO-2604-D5484Kestrel2026-Q399.933.24Supplier-supplied0PASS
AX-2026-042473LL-37HOMO-2602-G5165Janoshik2026-Q399.015.00Buyer-sourced0PASS
AX-2026-042441RetatrutideHOMO-2605-V4718Medutest2026-Q398.934.22Buyer-sourced0PASS
AX-2026-042474LL-37HOMO-2602-G5165Janoshik2026-Q399.185.44Buyer-sourced0PASS