AX-2024-004967

Semax · 20 mg declared · Xi'an Mokemei Biotechnology Co., Ltd. · lot MKM-2407-Y4392

PASSPURITY ONLY

Report ID: AX-2024-004967
Compound: Semax
Compound class: Neuroactive and cognitive peptides
Supplier: MKM — Xi'an Mokemei Biotechnology Co., Ltd.
Batch / lot: MKM-2407-Y4392
Declared label claim: 20mg
Laboratory: Nordanalyt Laboratories
Assay date: 28 Aug 2024
Submitted: 08 Sep 2024
Quarter: 2024-Q3
Submitter: b.kaufmann
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.

Parameter	Method	Result	Unit	Index spec
Purity	RP-HPLC, 35 min gradient, 214 nm	99.68	% area	≥ 98.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.32	% area	≤ 1.5	PASS
Largest single impurity	RP-HPLC — N-acetyl semax (+42 Da)	0.14	% area	≤ 1.00	PASS
Identity	not ordered on this submission	not determined	—	required for VERIFIED status	NOT TESTED
Peptide content	not ordered on this submission	not determined	—	required to check label claim	NOT TESTED
Water content	Karl Fischer, coulometric, duplicate	10.99	%	≤ 12.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	7.67	%	≤ 10.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.53	%	—	NOT TESTED
Endotoxin	not ordered on this submission	not determined	—	≤ 5.0	NOT TESTED
Sterility	membrane filtration, USP <71>, 14 d	No growth at 14 d	—	no growth	PASS
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	4.55	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 35 min gradient	7.99	min	8.14 ± 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	64,329	—	≥ 20,000	PASS
Resolution to nearest impurity	vs diketopiperazine (−18 Da)	1.45	—	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, 35 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 64,329, 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 0.14 % impurity against a 99.68 % 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	7.99	4,844,757	99.68	—
2	N-acetyl semax (+42 Da)	8.48	6,804	0.14	+42.011
3	Met1 sulfoxide (+16 Da)	7.57	4,374	0.09	+15.995
4	des-Met (−131 Da)	8.22	2,916	0.06	-131.040
5	diketopiperazine (−18 Da)	8.18	1,458	0.03	-18.011
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 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)	99.30	99.68	divergence -0.30 pp vs batch median
Total impurities (% area)	0.70	0.32
Largest single impurity (% area)	0.31	0.14
Water (%)	9.9	10.99
Counter-ion (%)	not stated	7.67
Peptide content (%w/w)	85.3	not determined
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: Buyer-sourced
Evidentiary weight: Strongest available evidence in this index.
Chain of custody: Retail purchase → submitter (−20 °C, 31 d) → laboratory (courier, dry ice, 9 d) → assay.
Assay date: 28 Aug 2024
Submitted to the index: 08 Sep 2024
Laboratory: Nordanalyt Laboratories, Uppsala, Sweden
Method basis: 35 min gradient · high-resolution MS
Verification status: PURITY ONLY

What this report does not establish

That the compound is the compound named. No identity confirmation was ordered on this submission. A purity figure describes chromatographic homogeneity of whatever eluted; it does not name it.
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 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.

storage_stated08 Sep 2024

The index cannot verify that the vial assayed is representative of the lot it came from, and says so on every record. Provenance narrows that gap; it does not close it.

valley_drop08 Sep 2024

N-acetyl semax (+42 Da) at 0.14 % elutes close enough to the main peak that drop-line and valley-to-valley will not agree. The index prints the resolution figure and applies no criterion to it — how close the nearest impurity sits is a property of the compound and the gradient, not of the system. What matters is that the convention used is stated.

hplc_ola08 Sep 2024

The reported figure derives from the plate count and the retention gap, via the pharmacopoeial form with the sum of both peak widths in the denominator. It is a calculated quantity, not a measured one, and it inherits the plate count's uncertainty.

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-2024-004968	MKM-2407-Y4392	Janoshik	2024-Q3	99.60	11.01	105.3	Supplier-supplied	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