AX-2024-005000

N-Acetyl Semax Amide · 5 mg declared · Zhuhai Kerui Biotechnology Co., Ltd. · lot KP-2407-W5062

FAILIDENTITY CONSISTENT

Report ID: AX-2024-005000
Compound: N-Acetyl Semax Amide
Compound class: Neuroactive and cognitive peptides
Supplier: KP — Zhuhai Kerui Biotechnology Co., Ltd.
Batch / lot: KP-2407-W5062
Declared label claim: 5mg
Laboratory: Janoshik Analytical
Assay date: 27 Oct 2024
Submitted: 20 Nov 2024
Quarter: 2024-Q4
Submitter: r.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.

Parameter	Method	Result	Unit	Index spec
Purity	RP-HPLC, 30 min gradient, 214 nm	98.35	% area	≥ 98.5	FAIL
Total impurities	RP-HPLC, sum of reported peaks	1.65	% area	≤ 1.5	FAIL
Largest single impurity	RP-HPLC — des-acetyl amide (−42 Da)	0.97	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	854.3806	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, high resolution (ESI-TOF/QTOF)	854.3766	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	-4.7	ppm	± 15	PASS
Peptide content	not ordered on this submission	not determined	—	required to check label claim	NOT TESTED
Water content	Karl Fischer, coulometric, duplicate	8.01	%	≤ 12.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	6.11	%	≤ 10.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.87	%	—	NOT TESTED
Endotoxin	not ordered on this submission	not determined	—	≤ 5.0	NOT TESTED
Sterility	not ordered on this submission	not determined	—	no growth	NOT TESTED
Appearance	visual, diffuse light, black and white background	White lyophilised cake, intact	—	white to off-white intact cake	PASS
Reconstitution clarity	reconstituted per submitter procedure	Clear, colourless, no visible particulates	—	clear, no visible particulates	PASS
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	5.38	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	7.59	min	7.62 ± 0.25 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.10	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	68,190	—	≥ 20,000	PASS
Resolution to nearest impurity	vs N-acetyl semax free acid (+1 Da)	1.85	—	no index criterion	REPORTED

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.

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 68,190, and skew follows the reported asymmetry factor of 1.10. 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 0.97 % impurity against a 98.35 % main peak is a line two pixels tall; the main peak runs off-scale there by design.

#	Peak	RT	Area (µV·s)	% area	Δ mass (Da)
1	N-Acetyl Semax Amide — main peak	7.59	4,780,115	98.35	—
2	des-acetyl amide (−42 Da)	7.19	47,145	0.97	-42.011
3	Met sulfoxide (+16 Da)	7.25	22,357	0.46	+15.995
4	N-acetyl semax free acid (+1 Da)	7.81	5,346	0.11	+0.984
5	semax (des-acetyl, des-amide, −41 Da)	7.03	5,346	0.11	-41.027
Closure check — purity + Σ impurities				100.00	CLOSES

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.

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 854.3766 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.

Charge	Theoretical m/z	Observed m/z	Δ m/z	Rel. abundance (%)
2+	428.1976	428.1956	-0.0020	59.3
1+	855.3879	855.3839	-0.0040	100.0

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.

Figure	Supplier COA	This report	Index note
Purity (% area)	97.80	98.35	divergence -0.54 pp vs batch median
Total impurities (% area)	2.20	1.65
Largest single impurity (% area)	1.57	0.97
Water (%)	7.6	8.01
Counter-ion (%)	not stated	6.11
Peptide content (%w/w)	not stated	not determined
Endotoxin (EU/mg)	not stated	not determined
Method stated on certificate	NO	—	no 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: Laboratory-retained
Evidentiary weight: Provenance documented, selection uncontrolled.
Chain of custody: Laboratory retained sample (−20 °C, 14 d since original receipt) → re-assay.
Assay date: 27 Oct 2024
Submitted to the index: 20 Nov 2024
Laboratory: Janoshik Analytical, Ostrava, Czechia
Method basis: 30 min gradient · high-resolution MS
Verification status: IDENTITY CONSISTENT

What this report does not establish

How much of the named compound is in the vial. Peptide content was not determined, so recovered mass cannot be calculated and the label claim cannot be checked.
That the material is free of bacterial endotoxin. Endotoxin was not measured. No chromatographic result bears on it.
That the material is sterile. Sterility was not tested.
That any other vial in the same lot has the same composition. One vial was tested. Within-lot vial-to-vial variation in this index has a median of 0.28 pp and a 90th percentile of 0.74 pp.
That any other lot from the same supplier has the same composition. Batch-to-batch variation is larger than within-batch variation for every supplier here.
That the material is suitable for administration to a human or an animal. These are research compounds. No result on this site is a safety assessment and the index takes no position on use.
That the material was manufactured by the supplier that sold it. Contract synthesis is normal in this market and twenty-nine batches in the index fingerprint to a bulk from a different company than the one named on the label.

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.

aspartimide20 Nov 2024

A pair of satellites either side of the main peak at roughly equal levels is the aspartimide signature. Worth checking the named-impurity table before attributing 1.65 % to coupling efficiency.

lipidation_step20 Nov 2024

On an acylated compound the mono-ester by-product of the side-chain step is the impurity that most often carries a result into this band, and it is regiochemistry rather than sloppiness. The named table above will say whether that is what happened here.

thin_coverage20 Nov 2024

Coverage on this compound is thin enough that one record moves the class median visibly. That is a statement about the index rather than about the material, and it is why the n= badge sits beside every aggregate.

Section 7

Related records

Same batch — lot KP-2407-W5062 n=2

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2024-004999	KP-2407-W5062	Janoshik	2024-Q4	98.32	8.20	88.8	Buyer-sourced	1	FAIL

Batch rollup and reproducibility assessment →

Cross-sections

Other recent N-Acetyl Semax Amide records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043327	CPC	CPC-2602-D1905	Nordanalyt	2026-Q3	99.05	5.67	90.6	Buyer-sourced	1	FAIL
AX-2026-043328	CPC	CPC-2602-D1905	Janoshik	2026-Q3	99.49	6.83	100.9	Supplier-supplied	0	PASS
AX-2026-043331	CPC	CPC-2602-D1905	Janoshik	2026-Q3	99.46	6.22	—	Supplier-supplied	0	PASS
AX-2026-043329	CPC	CPC-2602-D1905	Janoshik	2026-Q3	98.56	5.44	—	Buyer-sourced	0	PASS
AX-2026-043330	CPC	CPC-2602-D1905	Janoshik	2026-Q3	98.65	5.70	91.4	Laboratory-retained	0	PASS
AX-2026-043326	CPC	CPC-2602-D1905	VendorInvestigate	2026-Q3	98.93	5.74	107.0	Buyer-sourced	0	PASS
AX-2026-042484	Homopeptide	HOMO-2603-C5267	Janoshik	2026-Q2	99.17	8.61	92.1	Buyer-sourced	0	PASS
AX-2026-042488	Homopeptide	HOMO-2603-C5267	PeptideMeter	2026-Q2	98.83	8.48	—	Buyer-sourced	0	PASS

Other recent KP records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043095	Retatrutide	KP-2607-H5774	Janoshik	2026-Q3	95.81	5.48	105.2	Buyer-sourced	0	FAIL
AX-2026-043094	Retatrutide	KP-2607-H5774	PeptideMeter	2026-Q3	96.32	6.40	—	Buyer-sourced	0	FAIL
AX-2026-043096	Retatrutide	KP-2607-H5774	VendorInvestigate	2026-Q3	96.48	6.05	104.9	Buyer-sourced	0	FAIL
AX-2026-043090	Retatrutide	KP-2607-H5774	Janoshik	2026-Q3	96.46	5.81	—	Buyer-sourced	0	FAIL
AX-2026-043091	Retatrutide	KP-2607-H5774	Janoshik	2026-Q3	96.13	5.94	—	Buyer-sourced	0	FAIL
AX-2026-043077	TB-500	KP-2605-C5214	Janoshik	2026-Q2	99.61	5.64	90.2	Buyer-sourced	0	PASS
AX-2026-043093	Retatrutide	KP-2607-H5774	Janoshik	2026-Q3	96.54	5.54	—	Buyer-sourced	0	PASS
AX-2026-043092	Retatrutide	KP-2607-H5774	Medutest	2026-Q3	96.64	6.12	—	Buyer-sourced	1	FAIL