AssayIndex

AX-2025-018644

N-Acetyl Semax Amide · 10 mg declared · ChinaPeptides Co., Ltd. (QYAOBIO) · lot QYB-2411-G5768

PASSPURITY ONLY
Report ID
AX-2025-018644
Compound
N-Acetyl Semax Amide
Compound class
Neuroactive and cognitive peptides
Supplier
QYB — ChinaPeptides Co., Ltd. (QYAOBIO)
Batch / lot
QYB-2411-G5768
Declared label claim
10mg
Laboratory
Nordanalyt Laboratories
Assay date
13 Jun 2025
Submitted
14 Jun 2025
Quarter
2025-Q2
Submitter
vi.sjoberg
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, 35 min gradient, 214 nm99.52% area≥ 98.5PASS
Total impuritiesRP-HPLC, sum of reported peaks0.48% area≤ 1.5PASS
Largest single impurityRP-HPLC — des-acetyl amide (−42 Da)0.31% area≤ 1.00PASS
Identitynot ordered on this submissionnot determinedrequired for VERIFIED statusNOT TESTED
Total peptide contentby difference from the gravimetric mass balance83.28%w/wNOT TESTED
Target-compound contenttotal peptide content × purity82.88%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen11.55mg10 mg declaredNOT TESTED
Recovered target peptidegross fill × target content9.573mg10 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim95.7%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate10.54%≤ 12.0PASS
Counter-ion (acetate)anion-exchange ion chromatography5.88%≤ 10.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.30%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 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 calibration5.582.5 – 8.0PASS
Retention time (observed)RP-HPLC, 35 min gradient8.73min8.79 ± 0.25 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.000.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²94,437≥ 20,000PASS
Resolution to nearest impurityvs N-acetyl semax free acid (+1 Da)2.20no 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.

0405581101216616221 N-Acetyl Semax Amide8.73 min · 99.52 % 8.26 same trace · ×200 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 94,437, and skew follows the reported asymmetry factor of 1.00. 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 0.31 % impurity against a 99.52 % 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 peak8.734,836,98199.52
2des-acetyl amide (−42 Da)8.2615,0670.31-42.011
3Met sulfoxide (+16 Da)8.333,8880.08+15.995
4semax (des-acetyl, des-amide, −41 Da)8.082,9160.06-41.027
5N-acetyl semax free acid (+1 Da)8.991,4580.03+0.984
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 Fischer10.54
Counter-ion (acetate)ion chromatography5.88
Residual solvent + inorganic residueestimated0.30
Total peptide contentby difference83.28
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)99.9099.52divergence 0.00 pp vs batch median
Total impurities (% area)0.100.48
Largest single impurity (% area)not stated0.31
Water (%)9.410.54
Counter-ion (%)9.05.88
Peptide content (%w/w)81.083.28
Endotoxin (EU/mg)not statednot 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, 31 d since original receipt) → re-assay.
Assay date
13 Jun 2025
Submitted to the index
14 Jun 2025
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 QYB-2411-G5768 n=6

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2025-018645QYB-2411-G5768Janoshik2025-Q299.938.72Supplier-supplied0PASS
AX-2025-018646QYB-2411-G5768Janoshik2025-Q299.349.4695.9Supplier-supplied0PASS
AX-2025-018647QYB-2411-G5768Medutest2025-Q299.879.57Supplier-supplied0PASS
AX-2025-018648QYB-2411-G5768PeptideMeter2025-Q299.9310.0090.8Supplier-supplied0PASS
AX-2025-018649QYB-2411-G5768PeptideMeter2025-Q299.939.62Supplier-supplied0PASS
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 QYB records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041453RetatrutideQYB-2604-B5660VendorInvestigate2026-Q398.022.55Buyer-sourced1MARGINAL
AX-2026-041454RetatrutideQYB-2604-B5660Janoshik2026-Q398.842.77Supplier-supplied1MARGINAL
AX-2026-041538RetatrutideQYB-2602-G6308Medutest2026-Q398.502.85Supplier-supplied2MARGINAL
AX-2026-041456RetatrutideQYB-2604-B5660Janoshik2026-Q398.233.24Supplier-supplied1MARGINAL
AX-2026-041452RetatrutideQYB-2604-B5660Nordanalyt2026-Q398.503.36Supplier-supplied1MARGINAL
AX-2026-041427IpamorelinQYB-2605-H4298Janoshik2026-Q399.934.12Supplier-supplied0PASS
AX-2026-041488PT-141 (Bremelanotide)QYB-2607-L5615Janoshik2026-Q399.933.79Supplier-supplied0PASS
AX-2026-041459RetatrutideQYB-2604-B5660VendorInvestigate2026-Q397.912.8492.2Buyer-sourced1MARGINAL