AssayIndex

AX-2026-043734

N-Acetyl Semax Amide · 10 mg declared · Bachem Holding (Suzhou) Co., Ltd. · lot BCH-2602-E8475

FAILIDENTITY CONSISTENT
Report ID
AX-2026-043734
Compound
N-Acetyl Semax Amide
Compound class
Neuroactive and cognitive peptides
Supplier
BCH — Bachem Holding (Suzhou) Co., Ltd.
Batch / lot
BCH-2602-E8475
Declared label claim
10mg
Laboratory
Janoshik Analytical
Assay date
25 Aug 2026
Submitted
27 Aug 2026
Quarter
2026-Q3
Submitter
m.hovland
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 nm98.16% area≥ 98.5FAIL
Total impuritiesRP-HPLC, sum of reported peaks1.84% area≤ 1.5FAIL
Largest single impurityRP-HPLC — Met sulfoxide (+16 Da)0.78% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula854.3806DaNOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)854.3803DaNOT TESTED
Mass accuracyobserved vs theoretical-0.4ppm± 15PASS
Peptide contentnot ordered on this submissionnot determinedrequired to check label claimNOT TESTED
Water contentKarl Fischer, coulometric, duplicate9.35%≤ 12.0PASS
Counter-ion (acetate)anion-exchange ion chromatography6.52%≤ 10.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.31%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 procedureFaint haze, clearing on standingclear, no visible particulatesFAIL
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration5.442.5 – 8.0PASS
Retention time (observed)RP-HPLC, 30 min gradient7.51min7.62 ± 0.25 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.030.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²72,376≥ 20,000PASS
Resolution to nearest impurityvs N-acetyl semax free acid (+1 Da)1.92no 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.

0401080201203116041 N-Acetyl Semax Amide7.51 min · 98.16 % 7.17 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 72,376, and skew follows the reported asymmetry factor of 1.03. 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 0.78 % impurity against a 98.16 % 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 peak7.514,770,88098.16
2Met sulfoxide (+16 Da)7.1737,9100.78+15.995
3N-acetyl semax free acid (+1 Da)7.7325,2740.52+0.984
4semax (des-acetyl, des-amide, −41 Da)6.9513,6090.28-41.027
5des-acetyl amide (−42 Da)7.1112,6370.26-42.011
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 854.3803 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+428.1976428.1974-0.000255.1
1+855.3879855.3876-0.0003100.0
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)97.8098.16divergence -0.05 pp vs batch median
Total impurities (% area)2.201.84
Largest single impurity (% area)0.910.78
Water (%)not stated9.35
Counter-ion (%)not stated6.52
Peptide content (%w/w)not statednot determined
Endotoxin (EU/mg)1.62not 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, 10 d) → assay. Submitter did not handle the vial.
Assay date
25 Aug 2026
Submitted to the index
27 Aug 2026
Laboratory
Janoshik Analytical, Ostrava, Czechia
Method basis
30 min gradient · high-resolution MS
Verification status
IDENTITY CONSISTENT
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.

mass_defect
Before assigning Met sulfoxide (+16 Da) from retention alone, check the mass defect on the impurity peak. Plausible and implausible assignments separate cleanly and the check costs nothing.
fill_homogeneity
Three vials from one lot sent to three laboratories blind is the design that removes this ambiguity. It costs three tests and it settles the question permanently for that lot.
Section 7

Related records

Same batch — lot BCH-2602-E8475 n=10

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043726BCH-2602-E8475Janoshik2026-Q397.899.67104.2Buyer-sourced0FAIL
AX-2026-043727BCH-2602-E8475Janoshik2026-Q398.008.79Supplier-supplied0FAIL
AX-2026-043728BCH-2602-E8475Medutest2026-Q397.729.3897.5Buyer-sourced1FAIL
AX-2026-043729BCH-2602-E8475Janoshik2026-Q398.149.2397.2Supplier-supplied0FAIL
AX-2026-043730BCH-2602-E8475PeptideMeter2026-Q398.299.18Buyer-sourced0FAIL
AX-2026-043731BCH-2602-E8475Janoshik2026-Q397.548.2388.9Buyer-sourced1FAIL
AX-2026-043732BCH-2602-E8475Medutest2026-Q397.808.90Buyer-sourced0FAIL
AX-2026-043733BCH-2602-E8475Janoshik2026-Q397.429.41Buyer-sourced0FAIL
AX-2026-043735BCH-2602-E8475PeptideMeter2026-Q397.759.0599.6Buyer-sourced0FAIL
Other recent N-Acetyl Semax Amide records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043498CPCCPC-2602-D3496VendorInvestigate2026-Q398.236.05102.8Buyer-sourced1FAIL
AX-2026-043726BCHBCH-2602-E8475Janoshik2026-Q397.899.67104.2Buyer-sourced0FAIL
AX-2026-043497CPCCPC-2602-D3496Janoshik2026-Q398.595.6299.9Buyer-sourced0PASS
AX-2026-043495CPCCPC-2602-D3496Janoshik2026-Q398.865.63Buyer-sourced0PASS
AX-2026-043729BCHBCH-2602-E8475Janoshik2026-Q398.149.2397.2Supplier-supplied0FAIL
AX-2026-043731BCHBCH-2602-E8475Janoshik2026-Q397.548.2388.9Buyer-sourced1FAIL
AX-2026-043496CPCCPC-2602-D3496Nordanalyt2026-Q399.046.03Supplier-supplied0PASS
AX-2026-043727BCHBCH-2602-E8475Janoshik2026-Q398.008.79Supplier-supplied0FAIL
Other recent BCH records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043691BPC-157BCH-2603-L7768Janoshik2026-Q398.665.12Supplier-supplied1MARGINAL
AX-2026-043693BPC-157BCH-2603-L7768PeptideMeter2026-Q397.825.2194.9Buyer-sourced0FAIL
AX-2026-043686BPC-157BCH-2603-L7768VendorInvestigate2026-Q397.645.27Buyer-sourced0FAIL
AX-2026-043695BPC-157BCH-2603-L7768Janoshik2026-Q397.615.42Buyer-sourced0FAIL
AX-2026-043726N-Acetyl Semax AmideBCH-2602-E8475Janoshik2026-Q397.899.67104.2Buyer-sourced0FAIL
AX-2026-043688BPC-157BCH-2603-L7768Janoshik2026-Q397.945.56Buyer-sourced0FAIL
AX-2026-043658BPC-157BCH-2603-G6644Janoshik2026-Q398.454.37101.8Supplier-supplied0PASS
AX-2026-043692BPC-157BCH-2603-L7768VendorInvestigate2026-Q397.605.61Buyer-sourced0FAIL