AssayIndex

AX-2024-005412

Semax · 5 mg declared · WuXi TIDES (WuXi AppTec Testing Division) · lot WXT-2402-W3946

PASSPURITY ONLY
Report ID
AX-2024-005412
Compound
Semax
Compound class
Neuroactive and cognitive peptides
Supplier
WXT — WuXi TIDES (WuXi AppTec Testing Division)
Batch / lot
WXT-2402-W3946
Declared label claim
5mg
Laboratory
Nordanalyt Laboratories
Assay date
18 Jun 2024
Submitted
27 Jun 2024
Quarter
2024-Q2
Submitter
s.bakker
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, 35 min gradient, 214 nm98.84% area≥ 98.5PASS
Total impuritiesRP-HPLC, sum of reported peaks1.16% area≤ 1.5PASS
Largest single impurityRP-HPLC — diketopiperazine (−18 Da)0.64% area≤ 1.00PASS
Identitynot ordered on this submissionnot determinedrequired for VERIFIED statusNOT TESTED
Total peptide contentby difference from the gravimetric mass balance86.57%w/wNOT TESTED
Target-compound contenttotal peptide content × purity85.57%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen6.18mg5 mg declaredNOT TESTED
Recovered target peptidegross fill × target content5.288mg5 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim105.8%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate6.52%≤ 12.0PASS
Counter-ion (acetate)anion-exchange ion chromatography6.46%≤ 10.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.45%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 to pale-yellow 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 calibration5.422.5 – 8.0PASS
Retention time (observed)RP-HPLC, 35 min gradient8.01min8.14 ± 0.25 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.040.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²75,962≥ 20,000PASS
Resolution to nearest impurityvs diketopiperazine (−18 Da)1.57no 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.

0386077191157915438 Semax8.01 min · 98.84 % 8.20 same trace · ×100 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 0510152025303540 Retention time (min) Response (mAU)
Figure 1. RP-HPLC trace, 35 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 75,962, and skew follows the reported asymmetry factor of 1.04. 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 0.64 % impurity against a 98.84 % 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 peak8.014,803,93098.84
2diketopiperazine (−18 Da)8.2031,1060.64-18.011
3des-Met (−131 Da)8.2410,6930.22-131.040
4N-acetyl semax (+42 Da)8.508,2630.17+42.011
5Met1 sulfoxide (+16 Da)7.596,3180.13+15.995
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 Fischer6.52
Counter-ion (acetate)ion chromatography6.46
Residual solvent + inorganic residueestimated0.45
Total peptide contentby difference86.57
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)98.7398.84divergence +0.23 pp vs batch median
Total impurities (% area)not stated1.16
Largest single impurity (% area)not stated0.64
Water (%)4.56.52
Counter-ion (%)not stated6.46
Peptide content (%w/w)90.786.57
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, 6 d) → assay. Submitter did not handle the vial.
Assay date
18 Jun 2024
Submitted to the index
27 Jun 2024
Laboratory
Nordanalyt Laboratories, Uppsala, Sweden
Method basis
35 min gradient · high-resolution MS
Verification status
PURITY ONLY
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 WXT-2402-W3946 n=13

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2024-005401WXT-2402-W3946Kestrel2024-Q298.096.85Supplier-supplied0FAIL
AX-2024-005402WXT-2402-W3946Kestrel2024-Q298.506.4589.4Laboratory-retained1MARGINAL
AX-2024-005403WXT-2402-W3946Kestrel2024-Q298.796.6193.4Supplier-supplied0PASS
AX-2024-005404WXT-2402-W3946Medutest2024-Q298.206.7792.6Supplier-supplied0FAIL
AX-2024-005405WXT-2402-W3946Medutest2024-Q298.506.59103.2Laboratory-retained1MARGINAL
AX-2024-005406WXT-2402-W3946Medutest2024-Q298.617.19Supplier-supplied1FAIL
AX-2024-005407WXT-2402-W3946Medutest2024-Q298.646.8095.2Supplier-supplied0PASS
AX-2024-005408WXT-2402-W3946Janoshik2024-Q298.996.60Supplier-supplied1MARGINAL
AX-2024-005409WXT-2402-W3946Nordanalyt2024-Q298.346.76Buyer-sourced0FAIL
AX-2024-005410WXT-2402-W3946Medutest2024-Q299.176.77Supplier-supplied0PASS
AX-2024-005411WXT-2402-W3946Medutest2024-Q298.286.72Buyer-sourced0FAIL
AX-2024-005413WXT-2402-W3946Medutest2024-Q298.206.68Supplier-supplied0FAIL
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 WXT records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043488PramlintideWXT-2603-D6052Janoshik2026-Q397.874.37Supplier-supplied1MARGINAL
AX-2026-043406SemaglutideWXT-2604-C4728Janoshik2026-Q397.244.65Supplier-supplied1MARGINAL
AX-2026-043421SermorelinWXT-2608-P4867Janoshik2026-Q398.153.09Supplier-supplied0PASS
AX-2026-043420SermorelinWXT-2608-P4867Medutest2026-Q398.623.0796.4Supplier-supplied0PASS
AX-2026-043423SermorelinWXT-2608-P4867Janoshik2026-Q398.283.8698.5Buyer-sourced0PASS
AX-2026-043401SemaglutideWXT-2604-C4728Medutest2026-Q397.704.7891.5Supplier-supplied1MARGINAL
AX-2026-043400SemaglutideWXT-2604-C4728Nordanalyt2026-Q396.864.11106.4Laboratory-retained1FAIL
AX-2026-043422SermorelinWXT-2608-P4867Medutest2026-Q398.353.59Supplier-supplied1MARGINAL