AX-2024-004467 · Semax · AMB lot AMB-2411-G5528

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	99.93	% area	≥ 98.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.07	% area	≤ 1.5	PASS
Largest single impurity	RP-HPLC — Met1 sulfoxide (+16 Da)	0.04	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	813.3541	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, high resolution (ESI-TOF/QTOF)	813.3589	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+5.9	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	83.91	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	83.85	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	12.64	mg	10 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	10.599	mg	10 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	106.0	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	9.53	%	≤ 12.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	5.91	%	≤ 10.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.65	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	0.27	EU/mg	≤ 5.0	PASS
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	4.91	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	7.24	min	7.06 ± 0.25 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.12	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	54,710	—	≥ 20,000	PASS
Resolution to nearest impurity	vs Met1 sulfoxide (+16 Da)	2.84	—	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 54,710, and skew follows the reported asymmetry factor of 1.12. 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 0.04 % impurity against a 99.93 % 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	Semax — main peak	7.24	4,856,908	99.93	—
2	Met1 sulfoxide (+16 Da)	6.88	1,944	0.04	+15.995
3	N-acetyl semax (+42 Da)	7.66	1,458	0.03	+42.011
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 813.3541 Da, computed from C37H51N9O10S. 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 813.3589 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+	407.6843	407.6867	0.0024	51.0
1+	814.3614	814.3662	0.0048	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	9.53
Counter-ion (acetate)	ion chromatography	5.91
Residual solvent + inorganic residue	estimated	0.65
Total peptide content	by difference	83.91
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)	99.90	99.93	divergence -0.02 pp vs batch median
Total impurities (% area)	0.10	0.07
Largest single impurity (% area)	not stated	0.04
Water (%)	not stated	9.53
Counter-ion (%)	8.8	5.91
Peptide content (%w/w)	87.1	83.91
Endotoxin (EU/mg)	0.15	0.27
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 → submitter (ambient, 21 d) → laboratory (courier, cold pack, 6 d) → assay.
Assay date: 04 Nov 2024
Submitted to the index: 25 Nov 2024
Laboratory: Janoshik Analytical, Ostrava, Czechia
Method basis: 30 min gradient · high-resolution MS
Verification status: VERIFIED

What this report does not establish

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.

prep_hplc_cut25 Nov 2024

0.07 % total impurities on Semax means the preparative fraction was cut narrow. That trades yield for purity, and the trade was made in the buyer's favour on this lot.

lambda_21425 Nov 2024

At 214 nm the amide bond dominates the response, so a peptide impurity is seen roughly in proportion to its size. 99.93 % on this detection is the conservative reading; a 280 nm trace would flatter it.

isotope_cluster25 Nov 2024

The isotope pattern is consistent with the elemental composition of Semax. That is a second, independent check on identity and it agrees with the mass.

Section 7

Related records

Same batch — lot AMB-2411-G5528 n=7

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2025-019286	AMB-2411-G5528	Medutest	2024-Q4	99.53	9.78	—	Buyer-sourced	PASS
AX-2024-004464	AMB-2411-G5528	PeptideMeter	2024-Q4	99.92	9.21	99.7	Buyer-sourced	PASS
AX-2024-004465	AMB-2411-G5528	Medutest	2024-Q4	99.93	9.85	—	Buyer-sourced	PASS
AX-2024-004466	AMB-2411-G5528	Janoshik	2024-Q4	99.82	9.01	—	Buyer-sourced	PASS
AX-2024-004468	AMB-2411-G5528	Janoshik	2024-Q4	99.76	9.75	106.1	Buyer-sourced	PASS
AX-2024-004469	AMB-2411-G5528	Nordanalyt	2024-Q4	99.93	9.26	—	Laboratory-retained	PASS

Batch rollup and reproducibility assessment →

Cross-sections

Other recent Semax records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2026-042519	Homopeptide	HOMO-2605-S5227	Medutest	2026-Q3	99.75	5.55	—	Buyer-sourced	PASS
AX-2026-042517	Homopeptide	HOMO-2605-S5227	Janoshik	2026-Q3	99.92	5.88	—	Buyer-sourced	PASS
AX-2026-042518	Homopeptide	HOMO-2605-S5227	Janoshik	2026-Q3	99.76	5.61	—	Buyer-sourced	PASS
AX-2026-042524	Homopeptide	HOMO-2605-S5227	Janoshik	2026-Q3	99.93	5.75	100.9	Supplier-supplied	PASS
AX-2026-042516	Homopeptide	HOMO-2605-S5227	Janoshik	2026-Q3	99.93	5.87	95.1	Buyer-sourced	PASS
AX-2026-042522	Homopeptide	HOMO-2605-S5227	Nordanalyt	2026-Q3	99.93	5.49	—	Buyer-sourced	PASS
AX-2026-042520	Homopeptide	HOMO-2605-S5227	Medutest	2026-Q3	99.93	6.12	—	Buyer-sourced	PASS
AX-2026-042514	Homopeptide	HOMO-2605-S5227	Janoshik	2026-Q3	99.59	5.48	97.0	Buyer-sourced	PASS

Other recent AMB records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042002	Semaglutide	AMB-2607-N6274	VendorInvestigate	2026-Q3	98.23	6.37	97.1	Buyer-sourced	1	MARGINAL
AX-2026-042012	GHRP-6	AMB-2603-S5667	Janoshik	2026-Q3	99.37	5.90	88.8	Laboratory-retained	1	MARGINAL
AX-2026-041974	Tirzepatide	AMB-2603-C5112	Nordanalyt	2026-Q3	98.20	3.41	—	Buyer-sourced	0	PASS
AX-2026-041975	Tirzepatide	AMB-2603-C5112	Medutest	2026-Q3	97.88	3.45	106.9	Laboratory-retained	0	PASS
AX-2026-042005	Semaglutide	AMB-2607-N6274	PeptideMeter	2026-Q3	98.09	6.48	98.6	Buyer-sourced	1	MARGINAL
AX-2026-042008	Epitalon	AMB-2602-Y6433	Janoshik	2026-Q3	99.30	8.75	105.1	Buyer-sourced	0	PASS
AX-2026-042021	TB-500	AMB-2602-P5987	VendorInvestigate	2026-Q3	99.86	4.79	101.4	Buyer-sourced	0	PASS
AX-2026-042015	GHRP-6	AMB-2603-S5667	Janoshik	2026-Q3	99.54	6.44	97.1	Buyer-sourced	0	PASS