AssayIndex

AX-2024-004999

N-Acetyl Semax Amide · 5 mg declared · Zhuhai Kerui Biotechnology Co., Ltd. · lot KP-2407-W5062

FAILVERIFIED
Report ID
AX-2024-004999
Compound
N-Acetyl Semax Amide
Compound class
Neuroactive and cognitive peptides
Supplier
KP — Zhuhai Kerui Biotechnology Co., Ltd.
Batch / lot
KP-2407-W5062
Declared label claim
5mg
Laboratory
Janoshik Analytical
Assay date
16 Nov 2024
Submitted
12 Dec 2024
Quarter
2024-Q4
Submitter
n.bruun
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, 30 min gradient, 214 nm98.32% area≥ 98.5FAIL
Total impuritiesRP-HPLC, sum of reported peaks1.68% area≤ 1.5FAIL
Largest single impurityRP-HPLC — N-acetyl semax free acid (+1 Da)1.04% area≤ 1.00FAIL
Identity — theoretical monoisotopic masscalculated from molecular formula854.3806DaNOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)854.3795DaNOT TESTED
Mass accuracyobserved vs theoretical-1.3ppm± 15PASS
Total peptide contentby difference from the gravimetric mass balance86.86%w/wNOT TESTED
Target-compound contenttotal peptide content × purity85.40%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen5.20mg5 mg declaredNOT TESTED
Recovered target peptidegross fill × target content4.441mg5 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim88.8%90.0 – 110.0FAIL
Water contentKarl Fischer, coulometric, duplicate8.20%≤ 12.0PASS
Counter-ion (acetate)anion-exchange ion chromatography4.74%≤ 10.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.20%NOT TESTED
Endotoxinnot ordered on this submissionnot determined≤ 5.0NOT TESTED
Sterilitymembrane filtration, USP <71>, 14 dNo growth at 14 dno growthPASS
Appearancevisual, diffuse light, black and white backgroundOff-white 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 calibration4.562.5 – 8.0PASS
Retention time (observed)RP-HPLC, 30 min gradient7.62min7.62 ± 0.25 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.460.910.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²63,640≥ 20,000PASS
Resolution to nearest impurityvs N-acetyl semax free acid (+1 Da)1.78no 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.

0394578911183615782 N-Acetyl Semax Amide7.62 min · 98.32 % 7.84 same trace · ×50 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 63,640, and skew follows the reported asymmetry factor of 0.91. 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 1.04 % impurity against a 98.32 % 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 peak7.624,778,65798.32
2N-acetyl semax free acid (+1 Da)7.8450,5471.04+0.984
3Met sulfoxide (+16 Da)7.2815,5530.32+15.995
4semax (des-acetyl, des-amide, −41 Da)7.069,2350.19-41.027
5des-acetyl amide (−42 Da)7.226,3180.13-42.011
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 854.3795 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+428.1976428.1970-0.000658.9
1+855.3879855.3868-0.0011100.0
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 Fischer8.20
Counter-ion (acetate)ion chromatography4.74
Residual solvent + inorganic residueestimated0.20
Total peptide contentby difference86.86
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)97.8098.32divergence -0.54 pp vs batch median
Total impurities (% area)2.201.68
Largest single impurity (% area)1.571.04
Water (%)7.68.20
Counter-ion (%)not stated4.74
Peptide content (%w/w)not stated86.86
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 (ambient, 2 d) → laboratory (hand-carried, 11 d) → assay.
Assay date
16 Nov 2024
Submitted to the index
12 Dec 2024
Laboratory
Janoshik Analytical, Ostrava, Czechia
Method basis
30 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.

dimer_disulfide
An intermolecular disulfide dimer elutes late and reduces cleanly. If the named table shows one, a non-reducing versus reducing comparison converts an unexplained impurity into an explained one.
ppm_error
Instrument was evidently in calibration on the day. A run of results at this accuracy across a laboratory's sequence is the background against which an excursion becomes interpretable.
price_per_mg
Buyers optimise on purity because purity is the number on the certificate. Recovery is the number that determines what arrives, and it is on almost no certificate at all.
Section 7

Related records

Same batch — lot KP-2407-W5062 n=2

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2024-005000KP-2407-W5062Janoshik2024-Q498.358.01Laboratory-retained0FAIL
Other recent N-Acetyl Semax Amide records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043327CPCCPC-2602-D1905Nordanalyt2026-Q399.055.6790.6Buyer-sourced1FAIL
AX-2026-043328CPCCPC-2602-D1905Janoshik2026-Q399.496.83100.9Supplier-supplied0PASS
AX-2026-043331CPCCPC-2602-D1905Janoshik2026-Q399.466.22Supplier-supplied0PASS
AX-2026-043329CPCCPC-2602-D1905Janoshik2026-Q398.565.44Buyer-sourced0PASS
AX-2026-043330CPCCPC-2602-D1905Janoshik2026-Q398.655.7091.4Laboratory-retained0PASS
AX-2026-043326CPCCPC-2602-D1905VendorInvestigate2026-Q398.935.74107.0Buyer-sourced0PASS
AX-2026-042484HomopeptideHOMO-2603-C5267Janoshik2026-Q299.178.6192.1Buyer-sourced0PASS
AX-2026-042488HomopeptideHOMO-2603-C5267PeptideMeter2026-Q298.838.48Buyer-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