AX-2024-004124

Semax · 5 mg declared · Wuhan Wansheng Biotechnology Co., Ltd. · lot WWB-2308-N1754

PASSVERIFIED

Report ID: AX-2024-004124
Compound: Semax
Compound class: Neuroactive and cognitive peptides
Supplier: WWB — Wuhan Wansheng Biotechnology Co., Ltd.
Batch / lot: WWB-2308-N1754
Declared label claim: 5mg
Laboratory: Nordanalyt Laboratories
Assay date: 29 Jan 2024
Submitted: 10 Feb 2024
Quarter: 2024-Q1
Submitter: ke.dahlberg
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 — diketopiperazine (−18 Da)	0.21	% 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)	813.3527	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	-1.7	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	88.28	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	88.00	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	5.95	mg	5 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	5.236	mg	5 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	104.7	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	5.32	%	≤ 12.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	5.83	%	≤ 10.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.57	%	—	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	Off-white lyophilised cake, intact	—	white to off-white intact cake	PASS
Reconstitution clarity	reconstituted per submitter procedure	Faint haze, clearing on standing	—	clear, no visible particulates	FAIL
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	5.54	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 35 min gradient	8.07	min	8.14 ± 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	76,325	—	≥ 20,000	PASS
Resolution to nearest impurity	vs diketopiperazine (−18 Da)	1.56	—	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 76,325, 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 0.21 % 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	8.07	4,844,757	99.68	—
2	diketopiperazine (−18 Da)	8.26	10,207	0.21	-18.011
3	Met1 sulfoxide (+16 Da)	7.65	3,402	0.07	+15.995
4	N-acetyl semax (+42 Da)	8.56	972	0.02	+42.011
5	des-Met (−131 Da)	8.30	972	0.02	-131.040
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 813.3527 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	407.6836	-0.0007	49.7
1+	814.3614	814.3600	-0.0014	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	5.32
Counter-ion (acetate)	ion chromatography	5.83
Residual solvent + inorganic residue	estimated	0.57
Total peptide content	by difference	88.28
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)	99.25	99.68	divergence -0.23 pp vs batch median
Total impurities (% area)	not stated	0.32
Largest single impurity (% area)	not stated	0.21
Water (%)	3.7	5.32
Counter-ion (%)	not stated	5.83
Peptide content (%w/w)	99.0	88.28
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 → submitter (2–8 °C, 27 d) → laboratory (courier, ambient, 5 d) → assay.
Assay date: 29 Jan 2024
Submitted to the index: 10 Feb 2024
Laboratory: Nordanalyt Laboratories, Uppsala, Sweden
Method basis: 35 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.

prep_hplc_cut10 Feb 2024

0.32 % 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.

aspartimide10 Feb 2024

Aspartimide formation at an Asp-Gly or Asp-Ser motif shows up as a pair of late-eluting satellites. They are not present above the reporting threshold on this trace.

median_not_mean10 Feb 2024

One result at the top of the distribution should not move anybody's estimate much on its own. Purity distributions are compressed at the top and long-tailed at the bottom, so the informative observations are the low ones.

Section 7

Related records

Same batch — lot WWB-2308-N1754 n=14

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2024-004119	WWB-2308-N1754	VendorInvestigate	2024-Q1	99.26	5.42	99.3	Buyer-sourced	0	PASS
AX-2024-004120	WWB-2308-N1754	PeptideMeter	2024-Q1	99.26	5.23	104.7	Buyer-sourced	0	PASS
AX-2024-004121	WWB-2308-N1754	VendorInvestigate	2024-Q1	99.27	4.92	96.0	Buyer-sourced	0	PASS
AX-2024-004122	WWB-2308-N1754	Janoshik	2024-Q1	99.86	5.29	89.7	Buyer-sourced	1	MARGINAL
AX-2024-004123	WWB-2308-N1754	PeptideMeter	2024-Q1	99.23	6.08	94.9	Buyer-sourced	0	PASS
AX-2024-004125	WWB-2308-N1754	Janoshik	2024-Q1	99.76	5.00	94.2	Buyer-sourced	0	PASS
AX-2024-004126	WWB-2308-N1754	Janoshik	2024-Q1	99.52	5.28	95.9	Buyer-sourced	0	PASS
AX-2024-004127	WWB-2308-N1754	Janoshik	2024-Q1	99.26	5.49	93.9	Buyer-sourced	0	PASS
AX-2024-004128	WWB-2308-N1754	Janoshik	2024-Q1	99.41	5.18	—	Buyer-sourced	0	PASS
AX-2024-004129	WWB-2308-N1754	Janoshik	2024-Q1	99.66	5.44	—	Buyer-sourced	0	PASS
AX-2024-004130	WWB-2308-N1754	Janoshik	2024-Q1	99.45	4.90	104.8	Buyer-sourced	0	PASS
AX-2024-004131	WWB-2308-N1754	PeptideMeter	2024-Q1	99.64	5.61	99.7	Buyer-sourced	0	PASS
AX-2024-004132	WWB-2308-N1754	Janoshik	2024-Q1	99.51	5.11	94.6	Laboratory-retained	0	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 WWB records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041275	Liraglutide	WWB-2607-X2189	Nordanalyt	2026-Q3	99.33	4.39	—	Buyer-sourced	1	MARGINAL
AX-2026-041334	Semaglutide	WWB-2606-N3192	Janoshik	2026-Q3	98.93	4.62	99.9	Buyer-sourced	0	PASS
AX-2026-041337	Semaglutide	WWB-2606-N3192	Nordanalyt	2026-Q3	99.52	3.92	—	Buyer-sourced	0	PASS
AX-2026-041335	Semaglutide	WWB-2606-N3192	Janoshik	2026-Q3	99.15	4.27	98.9	Buyer-sourced	0	PASS
AX-2026-041271	Liraglutide	WWB-2607-X2189	Medutest	2026-Q3	99.52	4.57	97.4	Buyer-sourced	1	MARGINAL
AX-2026-041328	Semaglutide	WWB-2606-N3192	Janoshik	2026-Q3	98.99	4.47	106.1	Buyer-sourced	0	PASS
AX-2026-041333	Semaglutide	WWB-2606-N3192	Janoshik	2026-Q3	99.18	4.51	90.4	Laboratory-retained	0	PASS
AX-2026-041273	Liraglutide	WWB-2607-X2189	Janoshik	2026-Q3	99.31	5.52	104.8	Buyer-sourced	1	MARGINAL