AssayIndex

AX-2026-042956

N-Acetyl Semax Amide · 20 mg declared · Zhuhai Kerui Biotechnology Co., Ltd. · lot KP-2508-D4657

FAILVERIFIED
Report ID
AX-2026-042956
Compound
N-Acetyl Semax Amide
Compound class
Neuroactive and cognitive peptides
Supplier
KP — Zhuhai Kerui Biotechnology Co., Ltd.
Batch / lot
KP-2508-D4657
Declared label claim
20mg
Laboratory
PeptideMeter
Assay date
22 Dec 2025
Submitted
12 Jan 2026
Quarter
2025-Q4
Submitter
w.perrin
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, 28 min gradient, 214 nm98.99% area≥ 98.5PASS
Total impuritiesRP-HPLC, sum of reported peaks1.01% area≤ 1.5PASS
Largest single impurityRP-HPLC — N-acetyl semax free acid (+1 Da)0.60% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula854.3806DaNOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)854.3778DaNOT TESTED
Mass accuracyobserved vs theoretical-3.3ppm± 15PASS
Total peptide contentby difference from the gravimetric mass balance87.63%w/wNOT TESTED
Target-compound contenttotal peptide content × purity86.74%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen22.44mg20 mg declaredNOT TESTED
Recovered target peptidegross fill × target content19.464mg20 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim97.3%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate7.34%≤ 12.0PASS
Counter-ion (acetate)anion-exchange ion chromatography4.07%≤ 10.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.96%NOT TESTED
Endotoxinkinetic chromogenic LAL6.89EU/mg≤ 5.0FAIL
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 calibration4.302.5 – 8.0PASS
Retention time (observed)RP-HPLC, 28 min gradient7.11min7.15 ± 0.25 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.090.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²58,941≥ 20,000PASS
Resolution to nearest impurityvs N-acetyl semax free acid (+1 Da)1.71no 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.

0374474881123314977 N-Acetyl Semax Amide7.11 min · 98.99 % 7.32 same trace · ×100 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 58,941, and skew follows the reported asymmetry factor of 1.09. 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 0.60 % impurity against a 98.99 % main peak is a line two pixels tall; the main peak runs off-scale there by design.
#PeakRTArea (µV·s)% areaΔ mass (Da)
1N-Acetyl Semax Amide — main peak7.114,811,22198.99
2N-acetyl semax free acid (+1 Da)7.3229,1620.60+0.984
3Met sulfoxide (+16 Da)6.798,2630.17+15.995
4semax (des-acetyl, des-amide, −41 Da)6.596,8040.14-41.027
5des-acetyl amide (−42 Da)6.744,8600.10-42.011
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 854.3806 Da, computed from C39H54N10O10S. All ppm figures on this site are against monoisotopic values — see why that matters.

0255075100350450550650750850950 [M+1H]1+855.39[M+2H]2+428.20 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 854.3778 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+428.1976428.1962-0.001450.9
1+855.3879855.3851-0.0028100.0
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 Fischer7.34
Counter-ion (acetate)ion chromatography4.07
Residual solvent + inorganic residueestimated0.96
Total peptide contentby difference87.63
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)98.6398.99divergence -0.36 pp vs batch median
Total impurities (% area)1.371.01
Largest single impurity (% area)0.560.60
Water (%)6.57.34
Counter-ion (%)not stated4.07
Peptide content (%w/w)88.787.63
Endotoxin (EU/mg)not stated6.89
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
22 Dec 2025
Submitted to the index
12 Jan 2026
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.

wide_iqr
Endotoxin determined but the LAL method is not stated. Kinetic chromogenic and gel-clot give different results and different sensitivity. The value cannot be interpreted without knowing which.
6.89 EU/mg but the material was passed through a sterile sterile filter. Some filters leach endotoxins; the measurement does not distinguish material from filter contribution.
aib_two
High endotoxin 6.89 EU/mg on high-purity material vs purity suggests water quality at the fill step. If the lot was lyophilised from non-purified water, this is the expected finding.
Section 7

Related records

Same batch — lot KP-2508-D4657 n=1

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

Other recent N-Acetyl Semax Amide records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043368CPCCPC-2602-D2941Medutest2026-Q398.796.05102.1Supplier-supplied0PASS
AX-2026-043574BCHBCH-2602-E8253Janoshik2026-Q397.758.8597.9Supplier-supplied1FAIL
AX-2026-043575BCHBCH-2602-E8253Janoshik2026-Q397.449.19104.8Supplier-supplied1FAIL
AX-2026-043367CPCCPC-2602-D2941Nordanalyt2026-Q399.396.1692.4Supplier-supplied0PASS
AX-2026-043573BCHBCH-2602-E8253Janoshik2026-Q397.478.59Supplier-supplied1FAIL
AX-2026-043576BCHBCH-2602-E8253Janoshik2026-Q397.469.5392.4Laboratory-retained1FAIL
AX-2026-042746GGPepsGGPE-2512-A1206PeptideMeter2026-Q298.976.67Supplier-supplied2MARGINAL
AX-2026-042234HomopeptideHOMO-2603-C1382Janoshik2026-Q298.998.0099.6Supplier-supplied0PASS
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