AssayIndex

AX-2025-019340

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

PASSIDENTITY CONSISTENT
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
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.

ParameterMethodResultUnitIndex spec
PurityRP-HPLC, 15 min gradient, 214 nm99.71% area≥ 98.5PASS
Total impuritiesRP-HPLC, sum of reported peaks0.29% area≤ 1.5PASS
Largest single impurityRP-HPLC — des-hexanoyl (−98 Da)0.11% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula504.3312DaNOT TESTED
Identity — observed monoisotopic massLC-MS, unit resolution (single quadrupole)504.3293DaNOT TESTED
Mass accuracyobserved vs theoretical-3.7ppm± 15PASS
Total peptide contentby difference from the gravimetric mass balance92.59%w/wNOT TESTED
Target-compound contenttotal peptide content × purity92.32%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen19.87mg20 mg declaredNOT TESTED
Recovered target peptidegross fill × target content18.344mg20 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim91.7%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate7.11%≤ 12.0PASS
Counter-ionno ionisable counter-ion expectedN/Anot applicableNOT TESTED
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.30%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 calibration7.232.5 – 8.0PASS
Retention time (observed)RP-HPLC, 15 min gradient6.60min6.61 ± 0.30 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.200.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²67,354≥ 20,000PASS
Resolution to nearest impurityvs [D-Ile]-epimer0.67no 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.

0412682521237816504 Dihexa6.60 min · 99.71 % 5.396.737.75 same trace · ×200 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 048121620 Retention time (min) Response (mAU)
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 67,354, and skew follows the reported asymmetry factor of 1.20. 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 0.11 % impurity against a 99.71 % main peak is a line two pixels tall; the main peak runs off-scale there by design.
#PeakRTArea (µV·s)% areaΔ mass (Da)
1Dihexa — main peak6.604,846,21599.71
2des-hexanoyl (−98 Da)5.395,3460.11-98.074
3free acid (+1 Da)6.735,3460.11+0.984
4[D-Ile]-epimer6.531,9440.040.000
5hexanoyl bis-adduct (+98 Da)7.751,4580.03+98.074
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 3

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.

0255075100475500525550575 [M+1H]1+505.34 m/z Relative abundance (%)
Figure 2. ESI charge-state envelope, unit-resolution instrument. Sticks are placed at m/z = (M + z × 1.007276)/z for the observed neutral mass of 504.3293 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.
ChargeTheoretical m/zObserved m/zΔ m/zRel. abundance (%)
1+505.3385505.3366-0.0019100.0
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.

ComponentDetermination%w/w of cake
WaterKarl Fischer7.11
Counter-ionnone expected0.00
Residual solvent + inorganic residueestimated0.30
Total peptide contentby difference92.59
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)99.6299.71divergence -0.02 pp vs batch median
Total impurities (% area)0.380.29
Largest single impurity (% area)0.140.11
Water (%)5.57.11
Counter-ion (%)6.6N/A
Peptide content (%w/w)87.392.59
Endotoxin (EU/mg)not statednot 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
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
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.

isotope_cluster
Nothing here rules out a positional isomer with the same formula. Mass cannot; only chromatography can, and the gradient length on this record is the relevant fact for that.
schema_v2
Both the theoretical and the observed monoisotopic mass are in the published dataset, so the ppm figure can be re-derived rather than trusted. That is the intent of publishing both.
Section 7

Related records

Same batch — lot HYB-2501-T6290 n=6

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2025-019341HYB-2501-T6290Janoshik2025-Q299.487.2693.6Buyer-sourced0PASS
AX-2025-019342HYB-2501-T6290VendorInvestigate2025-Q299.577.16Buyer-sourced1MARGINAL
AX-2025-019343HYB-2501-T6290VendorInvestigate2025-Q299.396.8396.2Buyer-sourced0PASS
AX-2025-019344HYB-2501-T6290Kestrel2025-Q299.936.63Buyer-sourced0PASS
AX-2025-019345HYB-2501-T6290Kestrel2025-Q299.936.79Buyer-sourced0PASS
Other recent Dihexa records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041370WWBWWB-2601-C4091Kestrel2026-Q299.9311.05Buyer-sourced0PASS
AX-2026-041521QSCQSC-2512-D5887Janoshik2026-Q299.646.16Laboratory-retained0PASS
AX-2025-018407WWBWWB-2507-N1598Janoshik2025-Q399.619.31Buyer-sourced0PASS
AX-2025-019342HYBHYB-2501-T6290VendorInvestigate2025-Q299.577.16Buyer-sourced1MARGINAL
AX-2025-018408WWBWWB-2507-N1598Janoshik2025-Q399.798.96Buyer-sourced0PASS
AX-2025-019344HYBHYB-2501-T6290Kestrel2025-Q299.936.63Buyer-sourced0PASS
AX-2025-019343HYBHYB-2501-T6290VendorInvestigate2025-Q299.396.8396.2Buyer-sourced0PASS
AX-2025-019345HYBHYB-2501-T6290Kestrel2025-Q299.936.79Buyer-sourced0PASS
Other recent HYB records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042083MOTS-cHYB-2606-D7858Medutest2026-Q399.932.02Buyer-sourced0PASS
AX-2026-042090MOTS-cHYB-2606-D7858Janoshik2026-Q399.572.36Buyer-sourced1FAIL
AX-2026-042084MOTS-cHYB-2606-D7858Janoshik2026-Q399.282.79107.3Buyer-sourced0PASS
AX-2026-042087MOTS-cHYB-2606-D7858Janoshik2026-Q399.543.05Buyer-sourced0PASS
AX-2026-042085MOTS-cHYB-2606-D7858Janoshik2026-Q399.512.31Buyer-sourced0PASS
AX-2026-042088MOTS-cHYB-2606-D7858PeptideMeter2026-Q399.222.21Buyer-sourced0PASS
AX-2026-042086MOTS-cHYB-2606-D7858Janoshik2026-Q399.933.02Buyer-sourced1MARGINAL
AX-2026-042091CJC-1295 with DACHYB-2608-E7391Janoshik2026-Q399.385.53Buyer-sourced0PASS