AX-2024-005170 · N-Acetyl Semax Amide · SGN lot SGN-2407-R9375

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, 28 min gradient, 214 nm	98.64	% area	≥ 98.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	1.36	% area	≤ 1.5	PASS
Largest single impurity	RP-HPLC — semax (des-acetyl, des-amide, −41 Da)	0.55	% 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)	854.3817	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+1.3	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	84.87	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	83.72	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	25.12	mg	20 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	21.030	mg	20 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	105.2	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	7.75	%	≤ 12.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	6.58	%	≤ 10.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.80	%	—	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 powder, no defined cake (melt-back)	—	white to off-white intact cake	FAIL
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	5.03	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 28 min gradient	7.09	min	7.15 ± 0.25 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.09	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	70,967	—	≥ 20,000	PASS
Resolution to nearest impurity	vs N-acetyl semax free acid (+1 Da)	1.88	—	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, 28 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 70,967, and skew follows the reported asymmetry factor of 1.09. 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 0.55 % impurity against a 98.64 % 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	7.09	4,794,210	98.64	—
2	semax (des-acetyl, des-amide, −41 Da)	6.57	26,732	0.55	-41.027
3	des-acetyl amide (−42 Da)	6.72	17,497	0.36	-42.011
4	N-acetyl semax free acid (+1 Da)	7.30	13,609	0.28	+0.984
5	Met sulfoxide (+16 Da)	6.77	8,263	0.17	+15.995
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 854.3817 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	428.1981	0.0005	52.6
1+	855.3879	855.3890	0.0011	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.

Component	Determination	%w/w of cake
Water	Karl Fischer	7.75
Counter-ion (acetate)	ion chromatography	6.58
Residual solvent + inorganic residue	estimated	0.80
Total peptide content	by difference	84.87
Total		100.00 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.

Figure	Supplier COA	This report	Index note
Purity (% area)	98.86	98.64	divergence +0.30 pp vs batch median
Total impurities (% area)	0.81	1.36
Largest single impurity (% area)	1.14	0.55
Water (%)	not stated	7.75
Counter-ion (%)	not stated	6.58
Peptide content (%w/w)	not stated	84.87
Endotoxin (EU/mg)	not stated	not determined
Method stated on certificate	YES	—	column, 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 → third-party forwarder (18 d) → laboratory (courier, cold pack, 2 d) → assay.
Assay date: 10 Jul 2024
Submitted to the index: 28 Jul 2024
Laboratory: PeptideMeter, Tallinn, Estonia
Method basis: 28 min gradient · high-resolution MS
Verification status: VERIFIED

What this report does not establish

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.

chain_custody28 Jul 2024

Custody from checkout to injection is documented on this record. Provenance plus custody is what makes a single result generalise past the vial it came from.

dedupe_logic28 Jul 2024

Two retail purchases of the same lot from different buyers are genuinely independent. Two aliquots of one purchase are not, and the index does not treat them as such.

bland_altman28 Jul 2024

Where two laboratories tested the same retail lot, the paired difference is a clean estimate of inter-lab bias with no selection term in it at all. Those pairs are the backbone of the agreement analysis.

Section 7

Related records

Same batch — lot SGN-2407-R9375 n=12

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2024-005162	SGN-2407-R9375	Janoshik	2024-Q3	98.81	8.02	90.9	Buyer-sourced	2	MARGINAL
AX-2024-005163	SGN-2407-R9375	Janoshik	2024-Q3	98.36	8.53	—	Buyer-sourced	2	FAIL
AX-2024-005164	SGN-2407-R9375	Medutest	2024-Q3	98.36	8.36	—	Buyer-sourced	2	FAIL
AX-2024-005165	SGN-2407-R9375	VendorInvestigate	2024-Q3	98.74	8.31	—	Buyer-sourced	2	MARGINAL
AX-2024-005166	SGN-2407-R9375	Janoshik	2024-Q3	98.44	7.33	106.0	Buyer-sourced	2	FAIL
AX-2024-005167	SGN-2407-R9375	Janoshik	2024-Q3	98.51	7.90	99.6	Buyer-sourced	2	MARGINAL
AX-2024-005168	SGN-2407-R9375	Janoshik	2024-Q3	98.61	8.21	94.5	Buyer-sourced	2	MARGINAL
AX-2024-005169	SGN-2407-R9375	Janoshik	2024-Q3	98.30	7.71	102.5	Buyer-sourced	2	FAIL
AX-2024-005171	SGN-2407-R9375	PeptideMeter	2024-Q3	98.44	7.90	96.7	Supplier-supplied	2	FAIL
AX-2024-005172	SGN-2407-R9375	Janoshik	2024-Q3	99.07	8.40	102.9	Supplier-supplied	2	MARGINAL
AX-2024-005173	SGN-2407-R9375	Kestrel	2024-Q3	99.36	7.83	—	Buyer-sourced	2	MARGINAL

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 SGN records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043233	Afamelanotide	SGN-2602-Y9306	Janoshik	2026-Q3	98.76	4.02	92.2	Buyer-sourced	1	MARGINAL
AX-2026-043234	Afamelanotide	SGN-2602-Y9306	Kestrel	2026-Q3	99.93	4.16	—	Buyer-sourced	0	PASS
AX-2026-043240	SLU-PP-332	SGN-2602-X9377	Janoshik	2026-Q2	98.82	5.46	97.0	Buyer-sourced	0	PASS
AX-2026-043222	ARA-290	SGN-2605-X9069	PeptideMeter	2026-Q2	98.32	7.36	—	Buyer-sourced	0	PASS
AX-2026-043237	SLU-PP-332	SGN-2602-X9377	Janoshik	2026-Q2	98.47	6.22	100.0	Supplier-supplied	0	PASS
AX-2026-043227	ARA-290	SGN-2605-X9069	PeptideMeter	2026-Q2	98.38	7.21	95.6	Buyer-sourced	0	PASS
AX-2026-043239	SLU-PP-332	SGN-2602-X9377	VendorInvestigate	2026-Q2	98.28	5.37	—	Buyer-sourced	0	PASS
AX-2026-043229	ARA-290	SGN-2605-X9069	Janoshik	2026-Q2	98.21	7.43	—	Buyer-sourced	0	PASS