AX-2024-004968 · Semax · MKM lot MKM-2407-Y4392

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	99.60	% area	≥ 98.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.40	% area	≤ 1.5	PASS
Largest single impurity	RP-HPLC — Met1 sulfoxide (+16 Da)	0.22	% 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)	813.3539	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	-0.3	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	82.91	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	82.58	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	25.50	mg	20 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	21.058	mg	20 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	105.3	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	11.01	%	≤ 12.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	5.50	%	≤ 10.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.58	%	—	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	5.01	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	7.03	min	7.06 ± 0.25 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.07	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	85,930	—	≥ 20,000	PASS
Resolution to nearest impurity	vs diketopiperazine (−18 Da)	1.63	—	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 85,930, and skew follows the reported asymmetry factor of 1.07. 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 0.22 % impurity against a 99.60 % 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	7.03	4,840,869	99.60	—
2	Met1 sulfoxide (+16 Da)	6.67	10,693	0.22	+15.995
3	diketopiperazine (−18 Da)	7.19	4,374	0.09	-18.011
4	des-Met (−131 Da)	7.23	2,430	0.05	-131.040
5	N-acetyl semax (+42 Da)	7.45	1,944	0.04	+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 813.3539 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	407.6842	-0.0001	52.0
1+	814.3614	814.3612	-0.0002	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	11.01
Counter-ion (acetate)	ion chromatography	5.50
Residual solvent + inorganic residue	estimated	0.58
Total peptide content	by difference	82.91
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)	99.30	99.60	divergence -0.30 pp vs batch median
Total impurities (% area)	0.70	0.40
Largest single impurity (% area)	0.31	0.22
Water (%)	9.9	11.01
Counter-ion (%)	not stated	5.50
Peptide content (%w/w)	85.3	82.91
Endotoxin (EU/mg)	0.98	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: Supplier-supplied
Evidentiary weight: Weaker evidence. Read with the caveat below.
Chain of custody: Supplier despatch → laboratory direct (courier, cold pack, 2 d) → assay. Submitter did not handle the vial.
Assay date: 17 Sep 2024
Submitted to the index: 07 Oct 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 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 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.

prep_hplc_cut07 Oct 2024

0.40 % 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.

uncertainty_budget07 Oct 2024

Expanded uncertainty on a well-resolved main peak is about ±0.48 pp at 95 % confidence. 99.60 % should be read as a band, and the band is still comfortably above the class specification.

Section 7

Related records

Same batch — lot MKM-2407-Y4392 n=7

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2024-004965	MKM-2407-Y4392	Medutest	2024-Q3	99.50	11.06	—	Buyer-sourced	PASS
AX-2024-004966	MKM-2407-Y4392	PeptideMeter	2024-Q3	99.47	9.95	—	Buyer-sourced	PASS
AX-2024-004967	MKM-2407-Y4392	Nordanalyt	2024-Q3	99.68	10.99	—	Buyer-sourced	PASS
AX-2024-004969	MKM-2407-Y4392	Nordanalyt	2024-Q3	99.93	11.57	—	Supplier-supplied	PASS
AX-2024-004970	MKM-2407-Y4392	Nordanalyt	2024-Q3	99.60	11.37	105.6	Buyer-sourced	PASS
AX-2024-004971	MKM-2407-Y4392	Janoshik	2024-Q3	99.48	10.80	94.4	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 MKM records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2026-042942	CJC-1295 (no DAC)	MKM-2603-V3346	Janoshik	2026-Q3	99.52	3.43	—	Supplier-supplied	PASS
AX-2026-043019	Adipotide	MKM-2606-K5012	Janoshik	2026-Q3	97.61	5.77	105.1	Buyer-sourced	PASS
AX-2026-042939	CJC-1295 (no DAC)	MKM-2603-V3346	PeptideMeter	2026-Q3	99.44	3.39	—	Buyer-sourced	PASS
AX-2026-043020	Adipotide	MKM-2606-K5012	Medutest	2026-Q3	97.73	5.74	—	Buyer-sourced	PASS
AX-2026-043022	Adipotide	MKM-2606-K5012	Kestrel	2026-Q3	97.69	6.33	106.9	Buyer-sourced	PASS
AX-2026-043023	Adipotide	MKM-2606-K5012	Medutest	2026-Q3	97.48	5.56	103.7	Supplier-supplied	PASS
AX-2026-042945	CJC-1295 (no DAC)	MKM-2603-V3346	PeptideMeter	2026-Q3	99.39	3.54	—	Laboratory-retained	PASS
AX-2026-042938	CJC-1295 (no DAC)	MKM-2603-V3346	Nordanalyt	2026-Q3	99.47	3.67	95.0	Buyer-sourced	PASS