AssayIndex

AX-2024-004424

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

PASSPURITY ONLY
Report ID
AX-2024-004424
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
07 Jul 2024
Submitted
27 Jul 2024
Quarter
2024-Q3
Submitter
diode_array
Sample provenance
Laboratory-retained
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 — des-Met (−131 Da)0.05% area≤ 1.00PASS
Identitynot ordered on this submissionnot determinedrequired for VERIFIED statusNOT TESTED
Total peptide contentby difference from the gravimetric mass balance87.04%w/wNOT TESTED
Target-compound contenttotal peptide content × purity86.98%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen11.60mg10 mg declaredNOT TESTED
Recovered target peptidegross fill × target content10.090mg10 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim100.9%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate8.07%≤ 12.0PASS
Counter-ion (acetate)anion-exchange ion chromatography4.70%≤ 10.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.19%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, colourless, no visible particulatesclear, no visible particulatesPASS
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration5.972.5 – 8.0PASS
Retention time (observed)RP-HPLC, 30 min gradient7.13min7.06 ± 0.25 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.460.970.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²72,150≥ 20,000PASS
Resolution to nearest impurityvs diketopiperazine (−18 Da)1.47no 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.

0442488481327317697 Semax7.13 min · 99.93 % 7.33 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 72,150, and skew follows the reported asymmetry factor of 0.97. 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 0.05 % 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
2des-Met (−131 Da)7.332,4300.05-131.040
3diketopiperazine (−18 Da)7.299720.02-18.011
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 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 Fischer8.07
Counter-ion (acetate)ion chromatography4.70
Residual solvent + inorganic residueestimated0.19
Total peptide contentby difference87.04
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)99.8799.93divergence -0.06 pp vs batch median
Total impurities (% area)0.130.07
Largest single impurity (% area)0.080.05
Water (%)not stated8.07
Counter-ion (%)not stated4.70
Peptide content (%w/w)not stated87.04
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
Laboratory-retained
Evidentiary weight
Provenance documented, selection uncontrolled.
Chain of custody
Laboratory retained sample (−20 °C, 4 d since original receipt) → re-assay.
Assay date
07 Jul 2024
Submitted to the index
27 Jul 2024
Laboratory
Janoshik Analytical, Ostrava, Czechia
Method basis
30 min gradient · high-resolution MS
Verification status
PURITY ONLY
Section 6

Annotations 2

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.

buyer_sourced
Provenance and purity together are what make a figure like this usable. An independently purchased vial at 99.93 % is worth several supplier-selected ones.
method_absent
A resolution figure without a stated column and gradient is uninterpretable. Both are on this record, which is why the figure is worth printing at all.
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-2024-004419GSP-2404-P2784Janoshik2024-Q399.938.17Supplier-supplied0PASS
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-2024-004425GSP-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