AssayIndex

AX-2024-005036

Selank · 10 mg declared · Zhuhai Kerui Biotechnology Co., Ltd. · lot KP-2405-H5953

FAILIDENTITY CONSISTENT
Report ID
AX-2024-005036
Compound
Selank
Compound class
Neuroactive and cognitive peptides
Supplier
KP — Zhuhai Kerui Biotechnology Co., Ltd.
Batch / lot
KP-2405-H5953
Declared label claim
10mg
Laboratory
Kestrel Bioanalytical
Assay date
09 Jul 2024
Submitted
02 Aug 2024
Quarter
2024-Q3
Submitter
an.silva
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 nm98.00% area≥ 99.0FAIL
Total impuritiesRP-HPLC, sum of reported peaks2.00% area≤ 1.0FAIL
Largest single impurityRP-HPLC — des-Thr (−101 Da)1.00% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula751.4402DaNOT TESTED
Identity — observed monoisotopic massLC-MS, unit resolution (single quadrupole)751.4483DaNOT TESTED
Mass accuracyobserved vs theoretical+10.8ppm± 15PASS
Total peptide contentby difference from the gravimetric mass balance84.71%w/wNOT TESTED
Target-compound contenttotal peptide content × purity83.02%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen12.60mg10 mg declaredNOT TESTED
Recovered target peptidegross fill × target content10.461mg10 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim104.6%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate7.29%≤ 12.0PASS
Counter-ion (acetate)anion-exchange ion chromatography7.69%≤ 10.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.31%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 procedureClear, colourless, no visible particulatesclear, no visible particulatesPASS
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration5.862.5 – 8.0PASS
Retention time (observed)RP-HPLC, 15 min gradient3.34min3.47 ± 0.25 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.150.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²52,577≥ 20,000PASS
Resolution to nearest impurityvs diketopiperazine (−18 Da)1.51no 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.

07245144892173428978 Selank3.34 min · 98.00 % 3.21 same trace · ×50 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 52,577, and skew follows the reported asymmetry factor of 1.15. 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 1.00 % impurity against a 98.00 % main peak is a line two pixels tall; the main peak runs off-scale there by design.
#PeakRTArea (µV·s)% areaΔ mass (Da)
1Selank — main peak3.344,763,10498.00
2des-Thr (−101 Da)3.2148,6031.00-101.048
3acetyl adduct (+42 Da)3.5122,3570.46+42.011
4tuftsin fragment (−417 Da)3.0316,5250.34-417.235
5diketopiperazine (−18 Da)3.439,7210.20-18.011
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 751.4402 Da, computed from C33H57N11O9. All ppm figures on this site are against monoisotopic values — see why that matters.

0255075100325425525625725825 [M+1H]1+752.46[M+2H]2+376.73 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 751.4483 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 (%)
2+376.7274376.73140.004053.3
1+752.4475752.45560.0081100.0
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 Fischer7.29
Counter-ion (acetate)ion chromatography7.69
Residual solvent + inorganic residueestimated0.31
Total peptide contentby difference84.71
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)97.9398.00divergence +0.12 pp vs batch median
Total impurities (% area)2.072.00
Largest single impurity (% area)1.511.00
Water (%)not stated7.29
Counter-ion (%)5.57.69
Peptide content (%w/w)97.784.71
Endotoxin (EU/mg)not statednot determined
Method stated on certificateNOno 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, 30 d) → laboratory (courier, dry ice, 2 d) → assay.
Assay date
09 Jul 2024
Submitted to the index
02 Aug 2024
Laboratory
Kestrel Bioanalytical, Melbourne, Australia
Method basis
15 min gradient · unit-resolution MS
Verification status
IDENTITY CONSISTENT
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.

plate_count
Efficiency is the lever that does not change selectivity, so it improves resolution without moving anything else. Longer column, smaller particle, or lower flow, in that order of cost.
counterion_mol
7.69 % acetate against the number of basic residues in Selank is the stoichiometric check. It agrees here, which means the salt is the salt and not an excess of reagent.
Where the missing percent goes is the question I ask on every certificate. On this record it does not go anywhere, because there is not one.
Section 7

Related records

Same batch — lot KP-2405-H5953 n=2

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2024-005035KP-2405-H5953Janoshik2024-Q397.627.83Buyer-sourced0FAIL
Other recent Selank records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042858GGPepsGGPE-2603-J2447VendorInvestigate2026-Q398.878.8599.4Buyer-sourced0FAIL
AX-2026-042859GGPepsGGPE-2603-J2447PeptideMeter2026-Q398.929.48103.5Buyer-sourced0FAIL
AX-2026-041759TFSTFS-{CAT}-1712Janoshik2026-Q299.938.13102.2Buyer-sourced0PASS
AX-2026-042912GGPepsGGPE-2601-J3130Janoshik2026-Q299.759.4489.7Buyer-sourced1MARGINAL
AX-2026-041760TFSTFS-{CAT}-1712Janoshik2026-Q299.827.70Buyer-sourced0PASS
AX-2026-041752TFSTFS-{CAT}-1712Medutest2026-Q299.637.43Buyer-sourced1FAIL
AX-2026-042915GGPepsGGPE-2601-J3130PeptideMeter2026-Q299.5310.03Buyer-sourced0PASS
AX-2026-042910GGPepsGGPE-2601-J3130VendorInvestigate2026-Q299.629.21105.0Buyer-sourced0PASS
Other recent KP records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043095RetatrutideKP-2607-H5774Janoshik2026-Q395.815.48105.2Buyer-sourced0FAIL
AX-2026-043094RetatrutideKP-2607-H5774PeptideMeter2026-Q396.326.40Buyer-sourced0FAIL
AX-2026-043096RetatrutideKP-2607-H5774VendorInvestigate2026-Q396.486.05104.9Buyer-sourced0FAIL
AX-2026-043090RetatrutideKP-2607-H5774Janoshik2026-Q396.465.81Buyer-sourced0FAIL
AX-2026-043091RetatrutideKP-2607-H5774Janoshik2026-Q396.135.94Buyer-sourced0FAIL
AX-2026-043077TB-500KP-2605-C5214Janoshik2026-Q299.615.6490.2Buyer-sourced0PASS
AX-2026-043093RetatrutideKP-2607-H5774Janoshik2026-Q396.545.54Buyer-sourced0PASS
AX-2026-043092RetatrutideKP-2607-H5774Medutest2026-Q396.646.12Buyer-sourced1FAIL