AX-2024-004418

Semax · 10 mg declared · GenScript Biotech Corporation · lot GSP-2404-P2784

PASSIDENTITY CONSISTENT

Report ID: AX-2024-004418
Compound: Semax
Compound class: Neuroactive and cognitive peptides
Supplier: GSP — GenScript Biotech Corporation
Batch / lot: GSP-2404-P2784
Declared label claim: 10mg
Laboratory: Janoshik Analytical
Assay date: 24 Aug 2024
Submitted: 31 Aug 2024
Quarter: 2024-Q3
Submitter: p.salgado
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, 30 min gradient, 214 nm	99.69	% area	≥ 98.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.31	% area	≤ 1.5	PASS
Largest single impurity	RP-HPLC — des-Met (−131 Da)	0.13	% 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)	813.3548	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+0.9	ppm	± 15	PASS
Peptide content	not ordered on this submission	not determined	—	required to check label claim	NOT TESTED
Water content	Karl Fischer, coulometric, duplicate	7.60	%	≤ 12.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	4.71	%	≤ 10.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.32	%	—	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	Clear with a single visible fibre	—	clear, no visible particulates	FAIL
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	4.59	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	7.01	min	7.06 ± 0.25 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.19	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	76,778	—	≥ 20,000	PASS
Resolution to nearest impurity	vs diketopiperazine (−18 Da)	1.54	—	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 76,778, and skew follows the reported asymmetry factor of 1.19. 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 0.13 % impurity against a 99.69 % 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	7.01	4,845,243	99.69	—
2	des-Met (−131 Da)	7.21	6,318	0.13	-131.040
3	diketopiperazine (−18 Da)	7.17	5,346	0.11	-18.011
4	N-acetyl semax (+42 Da)	7.43	1,944	0.04	+42.011
5	Met1 sulfoxide (+16 Da)	6.65	1,458	0.03	+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 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 813.3548 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	407.6847	0.0004	53.8
1+	814.3614	814.3621	0.0007	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.

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)	99.87	99.69	divergence -0.06 pp vs batch median
Total impurities (% area)	0.13	0.31
Largest single impurity (% area)	0.08	0.13
Water (%)	not stated	7.60
Counter-ion (%)	not stated	4.71
Peptide content (%w/w)	not stated	not determined
Endotoxin (EU/mg)	0.50	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, 26 d) → laboratory (courier, ambient, 9 d) → assay.
Assay date: 24 Aug 2024
Submitted to the index: 31 Aug 2024
Laboratory: Janoshik Analytical, Ostrava, Czechia
Method basis: 30 min gradient · high-resolution MS
Verification status: IDENTITY CONSISTENT

What this report does not establish

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 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.

diode_array31 Aug 2024

99.69 % is normalised area, so it is silent on how much peptide is in the vial. Content and water are the numbers that answer that, and both are on this record. Purity is the good news; content is the actionable news.

lot_traceability31 Aug 2024

Lot GSP-2404-P2784 decodes to a manufacture date consistent with the custody chain above. Traceability plus 99.69 % is a complete story; either alone is half of one.

isotope_cluster31 Aug 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 GSP-2404-P2784 n=13

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2024-004416	GSP-2404-P2784	Janoshik	2024-Q3	99.93	8.00	—	Buyer-sourced	0	PASS
AX-2024-004417	GSP-2404-P2784	PeptideMeter	2024-Q3	99.50	8.18	—	Buyer-sourced	0	PASS
AX-2024-004419	GSP-2404-P2784	Janoshik	2024-Q3	99.93	8.17	—	Supplier-supplied	0	PASS
AX-2024-004420	GSP-2404-P2784	Medutest	2024-Q3	99.93	7.98	88.6	Buyer-sourced	1	MARGINAL
AX-2024-004421	GSP-2404-P2784	PeptideMeter	2024-Q3	99.93	9.04	97.0	Laboratory-retained	0	PASS
AX-2024-004422	GSP-2404-P2784	Janoshik	2024-Q3	99.88	8.98	—	Buyer-sourced	0	PASS
AX-2024-004423	GSP-2404-P2784	Medutest	2024-Q3	99.85	8.20	104.6	Buyer-sourced	0	PASS
AX-2024-004424	GSP-2404-P2784	Janoshik	2024-Q3	99.93	8.07	100.9	Laboratory-retained	0	PASS
AX-2024-004425	GSP-2404-P2784	Medutest	2024-Q3	99.93	7.73	102.8	Buyer-sourced	0	PASS
AX-2024-004426	GSP-2404-P2784	PeptideMeter	2024-Q3	99.77	8.78	93.3	Buyer-sourced	0	PASS
AX-2024-004427	GSP-2404-P2784	Janoshik	2024-Q3	99.93	8.53	—	Buyer-sourced	0	PASS
AX-2024-004428	GSP-2404-P2784	Medutest	2024-Q3	99.93	8.02	101.9	Buyer-sourced	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 GSP records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041831	Survodutide	GSP-2603-E3156	Kestrel	2026-Q3	99.91	5.50	93.2	Buyer-sourced	0	PASS
AX-2026-041836	Survodutide	GSP-2603-E3156	Janoshik	2026-Q3	98.65	5.34	90.3	Buyer-sourced	0	PASS
AX-2026-041837	Survodutide	GSP-2603-E3156	Janoshik	2026-Q3	98.33	5.37	—	Buyer-sourced	0	PASS
AX-2026-041833	Survodutide	GSP-2603-E3156	Janoshik	2026-Q3	98.08	4.91	99.3	Buyer-sourced	0	PASS
AX-2026-041832	Survodutide	GSP-2603-E3156	VendorInvestigate	2026-Q3	98.01	5.14	99.5	Buyer-sourced	0	PASS
AX-2026-041835	Survodutide	GSP-2603-E3156	Nordanalyt	2026-Q3	98.34	5.74	89.0	Buyer-sourced	1	MARGINAL
AX-2026-041834	Survodutide	GSP-2603-E3156	VendorInvestigate	2026-Q3	97.92	5.95	—	Buyer-sourced	0	PASS
AX-2026-041838	Survodutide	GSP-2603-E3156	PeptideMeter	2026-Q3	98.30	5.01	102.4	Buyer-sourced	0	PASS