AX-2026-042040

Epitalon · 10 mg declared · Shenzhen Hybio Pharmaceutical Co., Ltd. · lot HYB-2603-U7133

FAILMETHOD LIMITED

Report ID: AX-2026-042040
Compound: Epitalon
Compound class: Short bioregulator peptides
Supplier: HYB — Shenzhen Hybio Pharmaceutical Co., Ltd.
Batch / lot: HYB-2603-U7133
Declared label claim: 10mg
Laboratory: Janoshik Analytical
Assay date: 17 Jun 2026
Submitted: 24 Jun 2026
Quarter: 2026-Q2
Submitter: a.karlsen
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.

Parameter	Method	Result	Unit	Index spec
Purity	RP-HPLC, 30 min gradient, 214 nm	99.74	% area	≥ 99.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.26	% area	≤ 1.0	PASS
Largest single impurity	RP-HPLC — Ala-Glu-Asp tripeptide (−57 Da)	0.19	% area	≤ 1.00	PASS
Identity	not ordered on this submission	not determined	—	required for VERIFIED status	NOT TESTED
Peptide content	not ordered on this submission	not determined	—	required to check label claim	NOT TESTED
Water content	Karl Fischer, coulometric, duplicate	6.36	%	≤ 12.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	12.62	%	≤ 10.0	FAIL
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.19	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	0.44	EU/mg	≤ 5.0	PASS
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	4.34	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	4.63	min	4.62 ± 0.20 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.10	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	69,375	—	≥ 20,000	PASS
Resolution to nearest impurity	vs β-Asp isomer	1.39	—	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 69,375, and skew follows the reported asymmetry factor of 1.10. 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 0.19 % impurity against a 99.74 % 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	4.63	4,847,673	99.74	—
2	Ala-Glu-Asp tripeptide (−57 Da)	4.43	9,235	0.19	-57.021
3	aspartimide (−18 Da)	4.75	2,430	0.05	-18.011
4	diketopiperazine (−18 Da)	4.79	486	0.01	-18.011
5	β-Asp isomer	4.53	486	0.01	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 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)	99.56	99.74	divergence -0.24 pp vs batch median
Total impurities (% area)	0.44	0.26
Largest single impurity (% area)	0.21	0.19
Water (%)	4.4	6.36
Counter-ion (%)	not stated	12.62
Peptide content (%w/w)	not stated	not determined
Endotoxin (EU/mg)	not stated	0.44
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: Retail purchase → submitter (2–8 °C, 1 d) → laboratory (courier, ambient, 5 d) → assay.
Assay date: 17 Jun 2026
Submitted to the index: 24 Jun 2026
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 compound is the compound named. No identity confirmation was ordered on this submission. A purity figure describes chromatographic homogeneity of whatever eluted; it does not name it.
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 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 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.

valley_drop24 Jun 2026

Largest single impurity is Ala-Glu-Asp tripeptide (−57 Da) at 0.19 % area, and it is the only named peak above 0.1 %. The integration is unambiguous and 99.74 % can be taken at face value.

moq_reality24 Jun 2026

Retail purchases test the retail channel. Manufacturer-tier material bought at kilogram scale is a different product with different documentation, and this index sees very little of it.

ion_pair_ip24 Jun 2026

Purity 99.74 % with Ala-Glu-Asp tripeptide (−57 Da) at 0.19 % nearby. Read the pair together: the purity figure and its nearest neighbour are two views of one integration decision.

Section 7

Related records

Same batch — lot HYB-2603-U7133 n=4

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2026-042038	HYB-2603-U7133	VendorInvestigate	2026-Q2	99.86	6.83	95.7	Buyer-sourced	FAIL
AX-2026-042039	HYB-2603-U7133	Medutest	2026-Q2	99.93	6.17	103.9	Buyer-sourced	FAIL
AX-2026-042041	HYB-2603-U7133	Janoshik	2026-Q2	99.65	6.82	95.3	Buyer-sourced	FAIL

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 HYB records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042083	MOTS-c	HYB-2606-D7858	Medutest	2026-Q3	99.93	2.02	—	Buyer-sourced	0	PASS
AX-2026-042090	MOTS-c	HYB-2606-D7858	Janoshik	2026-Q3	99.57	2.36	—	Buyer-sourced	1	FAIL
AX-2026-042084	MOTS-c	HYB-2606-D7858	Janoshik	2026-Q3	99.28	2.79	107.3	Buyer-sourced	0	PASS
AX-2026-042087	MOTS-c	HYB-2606-D7858	Janoshik	2026-Q3	99.54	3.05	—	Buyer-sourced	0	PASS
AX-2026-042085	MOTS-c	HYB-2606-D7858	Janoshik	2026-Q3	99.51	2.31	—	Buyer-sourced	0	PASS
AX-2026-042088	MOTS-c	HYB-2606-D7858	PeptideMeter	2026-Q3	99.22	2.21	—	Buyer-sourced	0	PASS
AX-2026-042086	MOTS-c	HYB-2606-D7858	Janoshik	2026-Q3	99.93	3.02	—	Buyer-sourced	1	MARGINAL
AX-2026-042091	CJC-1295 with DAC	HYB-2608-E7391	Janoshik	2026-Q3	99.38	5.53	—	Buyer-sourced	0	PASS