AssayIndex

AX-2025-020403

Semax · 10 mg declared · Zhuhai Kerui Biotechnology Co., Ltd. · lot KP-2502-H4693

FAILVERIFIED
Report ID
AX-2025-020403
Compound
Semax
Compound class
Neuroactive and cognitive peptides
Supplier
KP — Zhuhai Kerui Biotechnology Co., Ltd.
Batch / lot
KP-2502-H4693
Declared label claim
10mg
Laboratory
Janoshik Analytical
Assay date
11 Apr 2025
Submitted
24 Apr 2025
Quarter
2025-Q2
Submitter
a.ostergaard
Sample provenance
Supplier-supplied
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, 30 min gradient, 214 nm98.80% area≥ 98.5PASS
Total impuritiesRP-HPLC, sum of reported peaks1.20% area≤ 1.5PASS
Largest single impurityRP-HPLC — Met1 sulfoxide (+16 Da)0.67% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula813.3541DaNOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)813.3351DaNOT TESTED
Mass accuracyobserved vs theoretical-23.3ppm± 15FAIL
Total peptide contentby difference from the gravimetric mass balance84.97%w/wNOT TESTED
Target-compound contenttotal peptide content × purity83.95%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen12.52mg10 mg declaredNOT TESTED
Recovered target peptidegross fill × target content10.511mg10 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim105.1%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate6.89%≤ 12.0PASS
Counter-ion (acetate)anion-exchange ion chromatography7.65%≤ 10.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.49%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 calibration5.172.5 – 8.0PASS
Retention time (observed)RP-HPLC, 30 min gradient7.09min7.06 ± 0.25 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.060.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²52,059≥ 20,000PASS
Resolution to nearest impurityvs diketopiperazine (−18 Da)1.26no 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.

0357371471072014293 Semax7.09 min · 98.80 % 6.73 same trace · ×100 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 05101520253035 Retention time (min) Response (mAU)
Figure 1. RP-HPLC trace, 30 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 52,059, and skew follows the reported asymmetry factor of 1.06. 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 0.67 % impurity against a 98.80 % main peak is a line two pixels tall; the main peak runs off-scale there by design.
#PeakRTArea (µV·s)% areaΔ mass (Da)
1Semax — main peak7.094,801,98698.80
2Met1 sulfoxide (+16 Da)6.7332,5640.67+15.995
3N-acetyl semax (+42 Da)7.5116,0390.33+42.011
4des-Met (−131 Da)7.296,3180.13-131.040
5diketopiperazine (−18 Da)7.253,4020.07-18.011
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 813.3541 Da, computed from C37H51N9O10S. All ppm figures on this site are against monoisotopic values — see why that matters.

0255075100350450550650750850 [M+1H]1+814.34[M+2H]2+407.67 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 813.3351 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+407.6843407.6748-0.009550.8
1+814.3614814.3424-0.0190100.0
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 Fischer6.89
Counter-ion (acetate)ion chromatography7.65
Residual solvent + inorganic residueestimated0.49
Total peptide contentby difference84.97
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)99.4098.80divergence +0.55 pp vs batch median
Total impurities (% area)not stated1.20
Largest single impurity (% area)not stated0.67
Water (%)4.46.89
Counter-ion (%)not stated7.65
Peptide content (%w/w)not stated84.97
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
Supplier-supplied
Evidentiary weight
Weaker evidence. Read with the caveat below.
Chain of custody
Supplier despatch → laboratory direct (courier, cold pack, 11 d) → assay. Submitter did not handle the vial.
Assay date
11 Apr 2025
Submitted to the index
24 Apr 2025
Laboratory
Janoshik Analytical, Ostrava, Czechia
Method basis
30 min gradient · high-resolution MS
Verification status
VERIFIED
Section 6

Annotations

No annotations on this record. Annotations are short signed technical comments from index contributors; see how to contribute.

Section 7

Related records

Same batch — lot KP-2502-H4693 n=8

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2025-020401KP-2502-H4693Janoshik2025-Q299.217.15Supplier-supplied0PASS
AX-2025-020402KP-2502-H4693Janoshik2025-Q298.346.63105.1Supplier-supplied0FAIL
AX-2025-020404KP-2502-H4693Medutest2025-Q299.196.62Supplier-supplied0PASS
AX-2025-020405KP-2502-H4693PeptideMeter2025-Q298.186.10103.3Supplier-supplied1FAIL
AX-2025-020406KP-2502-H4693Janoshik2025-Q298.606.5398.8Supplier-supplied0PASS
AX-2025-020407KP-2502-H4693PeptideMeter2025-Q298.916.13102.9Supplier-supplied0PASS
AX-2025-020408KP-2502-H4693PeptideMeter2025-Q298.996.1995.8Supplier-supplied0PASS
Other recent Semax records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042368HJHJ-2603-V4363Nordanalyt2026-Q399.177.26106.3Supplier-supplied1MARGINAL
AX-2026-042367HJHJ-2603-V4363Kestrel2026-Q399.106.7893.9Supplier-supplied1MARGINAL
AX-2026-042260HomopeptideHOMO-2605-S1342Medutest2026-Q399.446.0692.4Laboratory-retained1FAIL
AX-2026-042370HJHJ-2603-V4363Janoshik2026-Q398.947.16104.0Supplier-supplied1MARGINAL
AX-2026-042369HJHJ-2603-V4363Janoshik2026-Q399.267.6795.0Supplier-supplied1MARGINAL
AX-2026-041947TFCTFC-2602-F4591Nordanalyt2026-Q299.298.9892.3Supplier-supplied0PASS
AX-2026-041940TFCTFC-2602-F4591Janoshik2026-Q299.068.3898.8Buyer-sourced0PASS
AX-2026-043141SSASSA-2604-L7628Kestrel2026-Q298.848.5893.2Supplier-supplied2MARGINAL
Other recent KP records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043029RetatrutideKP-2607-H5219Medutest2026-Q395.455.71Supplier-supplied2FAIL
AX-2026-043030RetatrutideKP-2607-H5219Kestrel2026-Q395.976.9597.1Supplier-supplied2FAIL
AX-2026-043106TirzepatideKP-2608-D5921PeptideMeter2026-Q398.905.45105.4Supplier-supplied2MARGINAL
AX-2026-043108TirzepatideKP-2608-D5921Janoshik2026-Q399.705.45Supplier-supplied2MARGINAL
AX-2026-043039RetatrutideKP-2607-H5219Janoshik2026-Q396.145.62Supplier-supplied2FAIL
AX-2026-043100TirzepatideKP-2608-D5921VendorInvestigate2026-Q398.275.3194.4Buyer-sourced2MARGINAL
AX-2026-043090IpamorelinKP-2606-D5887Janoshik2026-Q398.183.07101.2Laboratory-retained1FAIL
AX-2026-043028RetatrutideKP-2607-H5219Janoshik2026-Q396.526.09Supplier-supplied2MARGINAL