AssayIndex

AX-2024-004533

Selank · 20 mg declared · Shenzhen Hybio Pharmaceutical Co., Ltd. · lot HYB-2405-C7630

PASSVERIFIED
Report ID
AX-2024-004533
Compound
Selank
Compound class
Neuroactive and cognitive peptides
Supplier
HYB — Shenzhen Hybio Pharmaceutical Co., Ltd.
Batch / lot
HYB-2405-C7630
Declared label claim
20mg
Laboratory
PeptideMeter
Assay date
23 Jun 2024
Submitted
05 Jul 2024
Quarter
2024-Q2
Submitter
warehouse_route
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, 28 min gradient, 214 nm99.70% area≥ 99.0PASS
Total impuritiesRP-HPLC, sum of reported peaks0.30% area≤ 1.0PASS
Largest single impurityRP-HPLC — tuftsin fragment (−417 Da)0.16% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula751.4402DaNOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)751.4417DaNOT TESTED
Mass accuracyobserved vs theoretical+2.0ppm± 15PASS
Total peptide contentby difference from the gravimetric mass balance84.30%w/wNOT TESTED
Target-compound contenttotal peptide content × purity84.05%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen23.51mg20 mg declaredNOT TESTED
Recovered target peptidegross fill × target content19.760mg20 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim98.8%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate7.08%≤ 12.0PASS
Counter-ion (acetate)anion-exchange ion chromatography7.81%≤ 10.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.81%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 calibration5.322.5 – 8.0PASS
Retention time (observed)RP-HPLC, 28 min gradient5.86min6.03 ± 0.25 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.140.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²76,253≥ 20,000PASS
Resolution to nearest impurityvs diketopiperazine (−18 Da)1.93no 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.

05083101651524820330 Selank5.86 min · 99.70 % 5.28 same trace · ×200 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 051015202530 Retention time (min) Response (mAU)
Figure 1. RP-HPLC trace, 28 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 76,253, and skew follows the reported asymmetry factor of 1.14. 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 0.16 % impurity against a 99.70 % 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 peak5.864,845,72999.70
2tuftsin fragment (−417 Da)5.287,7760.16-417.235
3acetyl adduct (+42 Da)6.182,9160.06+42.011
4des-Thr (−101 Da)5.621,9440.04-101.048
5diketopiperazine (−18 Da)6.031,9440.04-18.011
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+752.45[M+2H]2+376.73 m/z Relative abundance (%)
Figure 2. ESI charge-state envelope, high-resolution instrument. Sticks are placed at m/z = (M + z × 1.007276)/z for the observed neutral mass of 751.4417 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+376.7274376.72810.000755.8
1+752.4475752.44900.0015100.0
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 Fischer7.08
Counter-ion (acetate)ion chromatography7.81
Residual solvent + inorganic residueestimated0.81
Total peptide contentby difference84.30
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)99.2099.70divergence -0.50 pp vs batch median
Total impurities (% area)not stated0.30
Largest single impurity (% area)not stated0.16
Water (%)6.57.08
Counter-ion (%)not stated7.81
Peptide content (%w/w)not stated84.30
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 (2–8 °C, 15 d) → laboratory (courier, ambient, 7 d) → assay.
Assay date
23 Jun 2024
Submitted to the index
05 Jul 2024
Laboratory
PeptideMeter, Tallinn, Estonia
Method basis
28 min gradient · high-resolution MS
Verification status
VERIFIED
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.

ms_confirm
An orthogonal identity method on the same lot would make this the strongest class of record the index holds. Mass plus retention is already better than most.
aaa_hydrolysis
Content by hydrolysis assumes complete recovery of every residue. Where it disagrees with the balance by a percent or two, the hydrolysis is the more likely culprit.
price_per_mg
Once the balance closes, cost per milligram of peptide is computable from the invoice. That is the calculation this whole block exists to enable.
Section 7

Related records

Same batch — lot HYB-2405-C7630 n=1

This is the only report on this lot. One report is not a batch characterisation.

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 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