AssayIndex

AX-2026-043732

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

FAILPURITY ONLY
Report ID
AX-2026-043732
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
Medutest
Assay date
12 Jul 2026
Submitted
18 Jul 2026
Quarter
2026-Q3
Submitter
e.rasmussen
Sample provenance
Buyer-sourced
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, 25 min gradient, 214 nm97.80% area≥ 98.5FAIL
Total impuritiesRP-HPLC, sum of reported peaks2.20% area≤ 1.5FAIL
Largest single impurityRP-HPLC — Met sulfoxide (+16 Da)0.93% area≤ 1.00PASS
Identitynot ordered on this submissionnot determinedrequired for VERIFIED statusNOT TESTED
Peptide contentnot ordered on this submissionnot determinedrequired to check label claimNOT TESTED
Water contentKarl Fischer, coulometric, duplicate8.90%≤ 12.0PASS
Counter-ion (acetate)anion-exchange ion chromatography6.01%≤ 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 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 calibration5.232.5 – 8.0PASS
Retention time (observed)RP-HPLC, 25 min gradient6.40min6.45 ± 0.25 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.140.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²49,330≥ 20,000PASS
Resolution to nearest impurityvs N-acetyl semax free acid (+1 Da)1.55no 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.

0367273441101514687 N-Acetyl Semax Amide6.40 min · 97.80 % 6.12 same trace · ×50 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 0481216202428 Retention time (min) Response (mAU)
Figure 1. RP-HPLC trace, 25 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 49,330, and skew follows the reported asymmetry factor of 1.14. 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 0.93 % impurity against a 97.80 % 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 peak6.404,753,38397.80
2Met sulfoxide (+16 Da)6.1245,2010.93+15.995
3N-acetyl semax free acid (+1 Da)6.5830,1340.62+0.984
4semax (des-acetyl, des-amide, −41 Da)5.9316,0390.33-41.027
5des-acetyl amide (−42 Da)6.0715,5530.32-42.011
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 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)97.8097.80divergence -0.05 pp vs batch median
Total impurities (% area)2.202.20
Largest single impurity (% area)0.910.93
Water (%)not stated8.90
Counter-ion (%)not stated6.01
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
Buyer-sourced
Evidentiary weight
Strongest available evidence in this index.
Chain of custody
Retail purchase → submitter (ambient, 20 d) → laboratory (courier, cold pack, 8 d) → assay.
Assay date
12 Jul 2026
Submitted to the index
18 Jul 2026
Laboratory
Medutest, Ljubljana, Slovenia
Method basis
25 min gradient · unit-resolution MS
Verification status
PURITY ONLY
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.

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.
The gap between 97.80 % and the class specification should be read against an expanded uncertainty of roughly ±0.5 pp. A shortfall inside that band is not a finding; a shortfall well outside it is.
endotoxin_limit
Sterility and endotoxin are independent properties and are constantly confused. A sterile-filtered lot can carry a high burden and frequently does.
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-2026-043733BCH-2602-E8475Janoshik2026-Q397.429.41Buyer-sourced0FAIL
AX-2026-043734BCH-2602-E8475Janoshik2026-Q398.169.35Supplier-supplied0FAIL
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-2026-043734BCHBCH-2602-E8475Janoshik2026-Q398.169.35Supplier-supplied0FAIL
AX-2026-043731BCHBCH-2602-E8475Janoshik2026-Q397.548.2388.9Buyer-sourced1FAIL
AX-2026-043496CPCCPC-2602-D3496Nordanalyt2026-Q399.046.03Supplier-supplied0PASS
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