AssayIndex

AX-2026-042465

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

FAILMETHOD LIMITED
Report ID
AX-2026-042465
Compound
Epitalon
Compound class
Short bioregulator peptides
Supplier
Homopeptide — Hunan Aslsen Technology Co., Ltd.
Batch / lot
HOMO-2512-A5108
Declared label claim
10mg
Laboratory
Medutest
Assay date
22 May 2026
Submitted
28 May 2026
Quarter
2026-Q2
Submitter
v.sorensen
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, 25 min gradient, 214 nm99.89% area≥ 99.0PASS
Total impuritiesRP-HPLC, sum of reported peaks0.11% area≤ 1.0PASS
Largest single impurityRP-HPLC — aspartimide (−18 Da)0.07% area≤ 1.00PASS
Identitynot ordered on this submissionnot determinedrequired for VERIFIED statusNOT TESTED
Total peptide contentby difference from the gravimetric mass balance79.51%w/wNOT TESTED
Target-compound contenttotal peptide content × purity79.42%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen12.09mg10 mg declaredNOT TESTED
Recovered target peptidegross fill × target content9.602mg10 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim96.0%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate8.04%≤ 12.0PASS
Counter-ion (acetate)anion-exchange ion chromatography11.61%≤ 10.0FAIL
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.84%NOT TESTED
Endotoxinnot ordered on this submissionnot determined≤ 5.0NOT TESTED
Sterilitynot ordered on this submissionnot determinedno growthNOT TESTED
Appearancevisual, diffuse light, black and white backgroundWhite lyophilised cake, intactwhite to off-white intact cakePASS
Reconstitution clarityreconstituted per submitter procedureVisible particulates, did not clearclear, no visible particulatesFAIL
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration4.982.5 – 8.0PASS
Retention time (observed)RP-HPLC, 25 min gradient3.84min3.91 ± 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)²56,292≥ 20,000PASS
Resolution to nearest impurityvs β-Asp isomer1.26no 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.

06740134802022026960 Epitalon3.84 min · 99.89 % 3.94 same trace · ×200 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 0481216202428 Retention time (min) Response (mAU)
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 56,292, 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 0.07 % impurity against a 99.89 % 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 peak3.844,854,96499.89
2aspartimide (−18 Da)3.943,4020.07-18.011
3Ala-Glu-Asp tripeptide (−57 Da)3.679720.02-57.021
4β-Asp isomer3.769720.020.000
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.

ComponentDetermination%w/w of cake
WaterKarl Fischer8.04
Counter-ion (acetate)ion chromatography11.61
Residual solvent + inorganic residueestimated0.84
Total peptide contentby difference79.51
Total100.00 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.

FigureSupplier COAThis reportIndex note
Purity (% area)99.4199.89divergence -0.52 pp vs batch median
Total impurities (% area)not stated0.11
Largest single impurity (% area)not stated0.07
Water (%)5.88.04
Counter-ion (%)not stated11.61
Peptide content (%w/w)not stated79.51
Endotoxin (EU/mg)0.21not determined
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 → third-party forwarder (27 d) → laboratory (courier, cold pack, 12 d) → assay.
Assay date
22 May 2026
Submitted to the index
28 May 2026
Laboratory
Medutest, Ljubljana, Slovenia
Method basis
25 min gradient · unit-resolution MS
Verification status
METHOD LIMITED
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.

gradient_25
99.89 % 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.
multiple_compare
Restricting every supplier comparison to buyer-sourced records is the sensitivity analysis the scorecards publish. On the current dataset it changes no ordering that was not already inside measurement noise.
hilic_hana
Orthogonal selectivity solves what more of the same selectivity does not. HILIC on a pair that co-elutes on C18 frequently resolves it outright.
osmolality_chk
Counter-ion contributes to osmolality on reconstitution and peptide barely does. That is an orthogonal route to the same number for anyone without an ion chromatograph.
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-2026-042466HOMO-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-2026-042470HOMO-2512-A5108Janoshik2026-Q299.637.99Buyer-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-2026-042470HomopeptideHOMO-2512-A5108Janoshik2026-Q299.637.99Buyer-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