AssayIndex

AX-2024-004419

Semax · 10 mg declared · GenScript Biotech Corporation · lot GSP-2404-P2784

PASSIDENTITY CONSISTENT
Report ID
AX-2024-004419
Compound
Semax
Compound class
Neuroactive and cognitive peptides
Supplier
GSP — GenScript Biotech Corporation
Batch / lot
GSP-2404-P2784
Declared label claim
10mg
Laboratory
Janoshik Analytical
Assay date
19 Jul 2024
Submitted
07 Aug 2024
Quarter
2024-Q3
Submitter
m.halvorsen
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 nm99.93% area≥ 98.5PASS
Total impuritiesRP-HPLC, sum of reported peaks0.07% area≤ 1.5PASS
Largest single impurityRP-HPLC — N-acetyl semax (+42 Da)0.04% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula813.3541DaNOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)813.3557DaNOT TESTED
Mass accuracyobserved vs theoretical+2.0ppm± 15PASS
Peptide contentnot ordered on this submissionnot determinedrequired to check label claimNOT TESTED
Water contentKarl Fischer, coulometric, duplicate8.17%≤ 12.0PASS
Counter-ion (acetate)anion-exchange ion chromatography5.45%≤ 10.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.87%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 backgroundOff-white lyophilised cake, intactwhite to off-white intact cakePASS
Reconstitution clarityreconstituted per submitter procedureClear after 90 s gentle swirling, no particulatesclear, no visible particulatesPASS
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration4.392.5 – 8.0PASS
Retention time (observed)RP-HPLC, 30 min gradient7.13min7.06 ± 0.25 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.170.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²64,296≥ 20,000PASS
Resolution to nearest impurityvs des-Met (−131 Da)1.73no 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.

0379275831137515166 Semax7.13 min · 99.93 % 7.55 same trace · ×200 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 64,296, and skew follows the reported asymmetry factor of 1.17. 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 0.04 % impurity against a 99.93 % 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 peak7.134,856,90899.93
2N-acetyl semax (+42 Da)7.551,9440.04+42.011
3des-Met (−131 Da)7.331,4580.03-131.040
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+814.36[M+2H]2+407.69 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 813.3557 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+407.6843407.68510.000849.7
1+814.3614814.36300.0016100.0
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.

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)99.8799.93divergence -0.06 pp vs batch median
Total impurities (% area)0.130.07
Largest single impurity (% area)0.080.04
Water (%)not stated8.17
Counter-ion (%)not stated5.45
Peptide content (%w/w)not statednot determined
Endotoxin (EU/mg)0.50not determined
Method stated on certificateYEScolumn, gradient and wavelength given
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
19 Jul 2024
Submitted to the index
07 Aug 2024
Laboratory
Janoshik Analytical, Ostrava, Czechia
Method basis
30 min gradient · high-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.

ms_confirm
A reference standard on the same sequence would upgrade this from a good mass to a traceable one. The distinction matters where a result is going to be cited rather than merely read.
schema_v2
Both the theoretical and the observed monoisotopic mass are in the published dataset, so the ppm figure can be re-derived rather than trusted. That is the intent of publishing both.
lambda_214
Detection wavelength does not affect a mass determination but it does affect the purity figure sitting next to it. Both are stated on this record, which is the point.
Section 7

Related records

Same batch — lot GSP-2404-P2784 n=13

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2024-004416GSP-2404-P2784Janoshik2024-Q399.938.00Buyer-sourced0PASS
AX-2024-004417GSP-2404-P2784PeptideMeter2024-Q399.508.18Buyer-sourced0PASS
AX-2024-004418GSP-2404-P2784Janoshik2024-Q399.697.60Buyer-sourced0PASS
AX-2024-004420GSP-2404-P2784Medutest2024-Q399.937.9888.6Buyer-sourced1MARGINAL
AX-2024-004421GSP-2404-P2784PeptideMeter2024-Q399.939.0497.0Laboratory-retained0PASS
AX-2024-004422GSP-2404-P2784Janoshik2024-Q399.888.98Buyer-sourced0PASS
AX-2024-004423GSP-2404-P2784Medutest2024-Q399.858.20104.6Buyer-sourced0PASS
AX-2024-004424GSP-2404-P2784Janoshik2024-Q399.938.07100.9Laboratory-retained0PASS
AX-2024-004425GSP-2404-P2784Medutest2024-Q399.937.73102.8Buyer-sourced0PASS
AX-2024-004426GSP-2404-P2784PeptideMeter2024-Q399.778.7893.3Buyer-sourced0PASS
AX-2024-004427GSP-2404-P2784Janoshik2024-Q399.938.53Buyer-sourced0PASS
AX-2024-004428GSP-2404-P2784Medutest2024-Q399.938.02101.9Buyer-sourced0PASS
Other recent Semax records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042519HomopeptideHOMO-2605-S5227Medutest2026-Q399.755.55Buyer-sourced0PASS
AX-2026-042517HomopeptideHOMO-2605-S5227Janoshik2026-Q399.925.88Buyer-sourced0PASS
AX-2026-042518HomopeptideHOMO-2605-S5227Janoshik2026-Q399.765.61Buyer-sourced0PASS
AX-2026-042524HomopeptideHOMO-2605-S5227Janoshik2026-Q399.935.75100.9Supplier-supplied0PASS
AX-2026-042516HomopeptideHOMO-2605-S5227Janoshik2026-Q399.935.8795.1Buyer-sourced0PASS
AX-2026-042522HomopeptideHOMO-2605-S5227Nordanalyt2026-Q399.935.49Buyer-sourced0PASS
AX-2026-042520HomopeptideHOMO-2605-S5227Medutest2026-Q399.936.12Buyer-sourced0PASS
AX-2026-042514HomopeptideHOMO-2605-S5227Janoshik2026-Q399.595.4897.0Buyer-sourced0PASS
Other recent GSP records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041831SurvodutideGSP-2603-E3156Kestrel2026-Q399.915.5093.2Buyer-sourced0PASS
AX-2026-041836SurvodutideGSP-2603-E3156Janoshik2026-Q398.655.3490.3Buyer-sourced0PASS
AX-2026-041837SurvodutideGSP-2603-E3156Janoshik2026-Q398.335.37Buyer-sourced0PASS
AX-2026-041833SurvodutideGSP-2603-E3156Janoshik2026-Q398.084.9199.3Buyer-sourced0PASS
AX-2026-041832SurvodutideGSP-2603-E3156VendorInvestigate2026-Q398.015.1499.5Buyer-sourced0PASS
AX-2026-041835SurvodutideGSP-2603-E3156Nordanalyt2026-Q398.345.7489.0Buyer-sourced1MARGINAL
AX-2026-041834SurvodutideGSP-2603-E3156VendorInvestigate2026-Q397.925.95Buyer-sourced0PASS
AX-2026-041838SurvodutideGSP-2603-E3156PeptideMeter2026-Q398.305.01102.4Buyer-sourced0PASS