AX-2025-019340
Dihexa · 20 mg declared · Shenzhen Hybio Pharmaceutical Co., Ltd. · lot HYB-2501-T6290
- Report ID
- AX-2025-019340
- 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
- 21 Apr 2025
- Submitted
- 12 May 2025
- Quarter
- 2025-Q2
- Submitter
- a.sobczak
- Sample provenance
- Buyer-sourced
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 | 99.71 | % area | ≥ 98.5 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 0.29 | % area | ≤ 1.5 | PASS |
| Largest single impurity | RP-HPLC — des-hexanoyl (−98 Da) | 0.11 | % area | ≤ 1.00 | PASS |
| Identity — theoretical monoisotopic mass | calculated from molecular formula | 504.3312 | Da | — | NOT TESTED |
| Identity — observed monoisotopic mass | LC-MS, unit resolution (single quadrupole) | 504.3293 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | -3.7 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 92.59 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 92.32 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 19.87 | mg | 20 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 18.344 | mg | 20 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 91.7 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 7.11 | % | ≤ 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/ | 0.30 | % | — | 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 | Visible particulates, did not clear | — | clear, no visible particulates | FAIL |
| pH (reconstituted, 1 mg/mL) | potentiometric, two-point calibration | 7.23 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 15 min gradient | 6.60 | min | 6.61 ± 0.30 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.20 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 67,354 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs [D-Ile]-epimer | 0.67 | — | no index criterion | REPORTED |
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.
| # | Peak | RT | Area (µV·s) | % area | Δ mass (Da) |
|---|---|---|---|---|---|
| 1 | Dihexa — main peak | 6.60 | 4,846,215 | 99.71 | — |
| 2 | des-hexanoyl (−98 Da) | 5.39 | 5,346 | 0.11 | -98.074 |
| 3 | free acid (+1 Da) | 6.73 | 5,346 | 0.11 | +0.984 |
| 4 | [D-Ile]-epimer | 6.53 | 1,944 | 0.04 | 0.000 |
| 5 | hexanoyl bis-adduct (+98 Da) | 7.75 | 1,458 | 0.03 | +98.074 |
| 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.
Mass spectrum and identity
Theoretical monoisotopic mass 504.3312 Da, computed from C27H44N4O5. All ppm figures on this site are against monoisotopic values — see why that matters.
| Charge | Theoretical m/z | Observed m/z | Δ m/z | Rel. abundance (%) |
|---|---|---|---|---|
| 1+ | 505.3385 | 505.3366 | -0.0019 | 100.0 |
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.
| Component | Determination | %w/w of cake |
|---|---|---|
| Water | Karl Fischer | 7.11 |
| Counter-ion | none expected | 0.00 |
| Residual solvent + inorganic residue | estimated | 0.30 |
| Total peptide content | by difference | 92.59 |
| Total | 100.00 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.
| Figure | Supplier COA | This report | Index note |
|---|---|---|---|
| Purity (% area) | 99.62 | 99.71 | divergence -0.02 pp vs batch median |
| Total impurities (% area) | 0.38 | 0.29 | |
| Largest single impurity (% area) | 0.14 | 0.11 | |
| Water (%) | 5.5 | 7.11 | |
| Counter-ion (%) | 6.6 | N/A | |
| Peptide content (%w/w) | 87.3 | 92.59 | |
| Endotoxin (EU/mg) | not stated | not determined | |
| Method stated on certificate | YES | — | column, gradient and wavelength given |
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
- Domestic warehouse despatch → submitter (2–8 °C, 28 d) → laboratory (courier, cold pack, 7 d) → assay.
- Assay date
- 21 Apr 2025
- Submitted to the index
- 12 May 2025
- Laboratory
- Kestrel Bioanalytical, Melbourne, Australia
- Method basis
- 15 min gradient · unit-resolution MS
- Verification status
- IDENTITY CONSISTENT
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.
Related records
Same batch — lot HYB-2501-T6290 n=6
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| 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 |
| AX-2025-019345 | HYB-2501-T6290 | Kestrel | 2025-Q2 | 99.93 | 6.79 | — | Buyer-sourced | 0 | PASS |
Cross-sections
- All Dihexa records n=22
- All HYB records n=241
- All Kestrel records n=407
- All 2025-Q2 records n=619
- Dihexa by supplier
- Dihexa impurity profile
| 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-2025-019345 | HYB | HYB-2501-T6290 | Kestrel | 2025-Q2 | 99.93 | 6.79 | — | Buyer-sourced | 0 | PASS |
| 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 |