AX-2026-042289 · Epitalon · TFC lot TFC-2511-E9934

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	99.88	% area	≥ 99.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.12	% area	≤ 1.0	PASS
Largest single impurity	RP-HPLC — aspartimide (−18 Da)	0.05	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	390.1387	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, high resolution (ESI-TOF/QTOF)	390.1388	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+0.2	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	6.37	%	≤ 12.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	15.03	%	≤ 10.0	FAIL
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	1.01	%	—	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 cake, partially collapsed	—	white to off-white intact cake	FAIL
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	5.62	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	4.54	min	4.62 ± 0.20 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.01	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	65,757	—	≥ 20,000	PASS
Resolution to nearest impurity	vs β-Asp isomer	1.38	—	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 65,757, and skew follows the reported asymmetry factor of 1.01. 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 0.05 % impurity against a 99.88 % 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	Epitalon — main peak	4.54	4,854,478	99.88	—
2	aspartimide (−18 Da)	4.66	2,430	0.05	-18.011
3	diketopiperazine (−18 Da)	4.70	1,944	0.04	-18.011
4	β-Asp isomer	4.44	1,458	0.03	0.000
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 390.1387 Da, computed from C14H22N4O9. 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 390.1388 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+	391.1460	391.1461	0.0001	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)	99.90	99.88	divergence -0.03 pp vs batch median
Total impurities (% area)	0.10	0.12
Largest single impurity (% area)	0.05	0.05
Water (%)	4.0	6.37
Counter-ion (%)	not stated	15.03
Peptide content (%w/w)	not stated	not determined
Endotoxin (EU/mg)	0.13	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: Retail purchase → submitter (−20 °C, 13 d) → laboratory (courier, dry ice, 9 d) → assay.
Assay date: 08 Mar 2026
Submitted to the index: 27 Mar 2026
Laboratory: Janoshik Analytical, Ostrava, Czechia
Method basis: 30 min gradient · high-resolution MS
Verification status: METHOD LIMITED

What this report does not establish

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 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.

baseline_noise27 Mar 2026

Baseline on this trace is flat enough that the reporting threshold is doing real work rather than hiding peaks in noise. That is a precondition for believing 99.88 % and it is not always met.

area_percent27 Mar 2026

Area percent assumes unit response factors across every species present. At 99.88 % the assumption barely matters — there is not enough impurity for a response-factor error to move the figure by a tenth.

gradient_2527 Mar 2026

The gradient is on the record, which is the first thing that should be true of any purity figure and often is not. 30 min at Janoshik puts this comparison on a documented footing.

retest_date27 Mar 2026

A retest date on the certificate would tell you what the supplier is actually asserting about stability. Purity at 99.88 % on assay day is a starting condition, not a shelf life.

Section 7

Related records

Same batch — lot TFC-2511-E9934 n=7

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042285	TFC-2511-E9934	Janoshik	2026-Q1	99.93	6.31	104.1	Buyer-sourced	1	FAIL
AX-2026-042286	TFC-2511-E9934	Janoshik	2026-Q1	99.88	5.99	95.8	Buyer-sourced	0	PASS
AX-2026-042287	TFC-2511-E9934	VendorInvestigate	2026-Q1	99.48	5.92	—	Buyer-sourced	0	FAIL
AX-2026-042288	TFC-2511-E9934	Medutest	2026-Q1	99.93	6.34	—	Buyer-sourced	0	PASS
AX-2026-042290	TFC-2511-E9934	Janoshik	2026-Q1	99.93	5.90	101.7	Buyer-sourced	0	FAIL
AX-2026-042291	TFC-2511-E9934	PeptideMeter	2026-Q1	99.93	6.23	103.2	Buyer-sourced	0	PASS

Batch rollup and reproducibility assessment →

Cross-sections

Other recent Epitalon records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2026-042008	AMB	AMB-2602-Y6433	Janoshik	2026-Q3	99.30	8.75	105.1	Buyer-sourced	PASS
AX-2026-042009	AMB	AMB-2602-Y6433	VendorInvestigate	2026-Q3	99.16	8.62	102.3	Buyer-sourced	FAIL
AX-2026-042010	AMB	AMB-2602-Y6433	Janoshik	2026-Q3	99.09	8.20	103.4	Laboratory-retained	FAIL
AX-2026-042007	AMB	AMB-2602-Y6433	Janoshik	2026-Q3	99.42	8.62	93.8	Buyer-sourced	FAIL
AX-2026-042468	Homopeptide	HOMO-2512-A5108	Janoshik	2026-Q2	99.93	7.81	100.8	Buyer-sourced	PASS
AX-2026-042463	Homopeptide	HOMO-2512-A5108	Janoshik	2026-Q2	99.93	7.68	93.2	Buyer-sourced	FAIL
AX-2026-042041	HYB	HYB-2603-U7133	Janoshik	2026-Q2	99.65	6.82	95.3	Buyer-sourced	FAIL
AX-2026-042470	Homopeptide	HOMO-2512-A5108	Janoshik	2026-Q2	99.63	7.99	—	Buyer-sourced	FAIL

Other recent TFC records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042265	Humanin (HNG)	TFC-2605-U1300	PeptideMeter	2026-Q3	99.52	6.31	—	Buyer-sourced	0	PASS
AX-2026-042222	SS-31 (Elamipretide)	TFC-2607-R9099	VendorInvestigate	2026-Q3	99.46	5.41	102.6	Buyer-sourced	0	PASS
AX-2026-042236	Humanin (HNG)	TFC-2608-S9940	Nordanalyt	2026-Q3	98.64	1.80	—	Buyer-sourced	0	PASS
AX-2026-042282	Retatrutide	TFC-2608-J1156	Janoshik	2026-Q3	98.54	4.27	—	Buyer-sourced	0	PASS
AX-2026-042226	SS-31 (Elamipretide)	TFC-2607-R9099	Janoshik	2026-Q3	99.62	5.47	—	Buyer-sourced	0	PASS
AX-2026-042217	Semaglutide	TFC-2604-X9037	PeptideMeter	2026-Q3	98.95	4.61	96.9	Buyer-sourced	0	PASS
AX-2026-042339	Sermorelin	TFC-2605-Y2176	Kestrel	2026-Q3	99.93	4.14	—	Supplier-supplied	1	FAIL
AX-2026-042214	Semaglutide	TFC-2604-X9037	Kestrel	2026-Q3	99.87	4.66	103.1	Laboratory-retained	0	PASS