AX-2025-019345

Dihexa · 20 mg declared · Shenzhen Hybio Pharmaceutical Co., Ltd. · lot HYB-2501-T6290

PASSPURITY ONLY

Report ID: AX-2025-019345
Compound: Dihexa
Compound class: Neuroactive and cognitive peptides
Supplier: HYB — Shenzhen Hybio Pharmaceutical Co., Ltd.
Batch / lot: HYB-2501-T6290
Declared label claim: 20mg
Laboratory: Kestrel Bioanalytical
Assay date: 23 May 2025
Submitted: 08 Jun 2025
Quarter: 2025-Q2
Submitter: m.ostergaard
Sample provenance: Buyer-sourced

Section 1

Results

Measured against the index acceptance specification for the neuroactive and cognitive 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, 15 min gradient, 214 nm	99.93	% area	≥ 98.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.07	% area	≤ 1.5	PASS
Largest single impurity	RP-HPLC — [D-Ile]-epimer	0.04	% 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	6.79	%	≤ 12.0	PASS
Counter-ion	no ionisable counter-ion expected	N/A	—	not applicable	NOT TESTED
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.33	%	—	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	5.88	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 15 min gradient	6.53	min	6.61 ± 0.30 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.24	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	67,332	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [D-Ile]-epimer	0.68	—	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, 15 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 67,332, and skew follows the reported asymmetry factor of 1.24. 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 0.04 % impurity against a 99.93 % 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	Dihexa — main peak	6.53	4,856,908	99.93	—
2	[D-Ile]-epimer	6.46	1,944	0.04	0.000
3	free acid (+1 Da)	6.66	1,458	0.03	+0.984
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)	99.62	99.93	divergence -0.02 pp vs batch median
Total impurities (% area)	0.38	0.07
Largest single impurity (% area)	0.14	0.04
Water (%)	5.5	6.79
Counter-ion (%)	6.6	N/A
Peptide content (%w/w)	87.3	not determined
Endotoxin (EU/mg)	not stated	not determined
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 (ambient, 18 d) → laboratory (courier, cold pack, 3 d) → assay.
Assay date: 23 May 2025
Submitted to the index: 08 Jun 2025
Laboratory: Kestrel Bioanalytical, Melbourne, Australia
Method basis: 15 min gradient · unit-resolution MS
Verification status: PURITY ONLY

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 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 2

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.

chain_custody08 Jun 2025

Custody from checkout to injection is documented on this record. Provenance plus custody is what makes a single result generalise past the vial it came from.

multiple_compare08 Jun 2025

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.

Section 7

Related records

Same batch — lot HYB-2501-T6290 n=6

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-019340	HYB-2501-T6290	Kestrel	2025-Q2	99.71	7.11	91.7	Buyer-sourced	0	PASS
AX-2025-019341	HYB-2501-T6290	Janoshik	2025-Q2	99.48	7.26	93.6	Buyer-sourced	0	PASS
AX-2025-019342	HYB-2501-T6290	VendorInvestigate	2025-Q2	99.57	7.16	—	Buyer-sourced	1	MARGINAL
AX-2025-019343	HYB-2501-T6290	VendorInvestigate	2025-Q2	99.39	6.83	96.2	Buyer-sourced	0	PASS
AX-2025-019344	HYB-2501-T6290	Kestrel	2025-Q2	99.93	6.63	—	Buyer-sourced	0	PASS

Batch rollup and reproducibility assessment →

Cross-sections

Other recent Dihexa records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041370	WWB	WWB-2601-C4091	Kestrel	2026-Q2	99.93	11.05	—	Buyer-sourced	0	PASS
AX-2026-041521	QSC	QSC-2512-D5887	Janoshik	2026-Q2	99.64	6.16	—	Laboratory-retained	0	PASS
AX-2025-018407	WWB	WWB-2507-N1598	Janoshik	2025-Q3	99.61	9.31	—	Buyer-sourced	0	PASS
AX-2025-019342	HYB	HYB-2501-T6290	VendorInvestigate	2025-Q2	99.57	7.16	—	Buyer-sourced	1	MARGINAL
AX-2025-018408	WWB	WWB-2507-N1598	Janoshik	2025-Q3	99.79	8.96	—	Buyer-sourced	0	PASS
AX-2025-019344	HYB	HYB-2501-T6290	Kestrel	2025-Q2	99.93	6.63	—	Buyer-sourced	0	PASS
AX-2025-019343	HYB	HYB-2501-T6290	VendorInvestigate	2025-Q2	99.39	6.83	96.2	Buyer-sourced	0	PASS
AX-2025-019340	HYB	HYB-2501-T6290	Kestrel	2025-Q2	99.71	7.11	91.7	Buyer-sourced	0	PASS

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