AX-2024-005283 · Semax · GL Biochem lot GLBI-2404-U8654

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	98.72	% area	≥ 98.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	1.28	% area	≤ 1.5	PASS
Largest single impurity	RP-HPLC — Met1 sulfoxide (+16 Da)	0.57	% 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)	813.3549	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+1.0	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	86.88	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	85.77	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	5.29	mg	5 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	4.537	mg	5 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	90.7	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	7.11	%	≤ 12.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	5.45	%	≤ 10.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.56	%	—	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	Slow dissolution, >5 min to clarity	—	clear, no visible particulates	FAIL
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	5.34	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	7.10	min	7.06 ± 0.25 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	0.86	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	79,726	—	≥ 20,000	PASS
Resolution to nearest impurity	vs diketopiperazine (−18 Da)	1.55	—	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 79,726, and skew follows the reported asymmetry factor of 0.86. 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 0.57 % impurity against a 98.72 % 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	7.10	4,798,098	98.72	—
2	Met1 sulfoxide (+16 Da)	6.74	27,704	0.57	+15.995
3	diketopiperazine (−18 Da)	7.26	14,581	0.30	-18.011
4	des-Met (−131 Da)	7.30	10,207	0.21	-131.040
5	N-acetyl semax (+42 Da)	7.52	9,721	0.20	+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 813.3549 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	57.7
1+	814.3614	814.3622	0.0008	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	7.11
Counter-ion (acetate)	ion chromatography	5.45
Residual solvent + inorganic residue	estimated	0.56
Total peptide content	by difference	86.88
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)	99.5	98.72	divergence +0.60 pp vs batch median
Total impurities (% area)	0.50	1.28
Largest single impurity (% area)	0.17	0.57
Water (%)	not stated	7.11
Counter-ion (%)	not stated	5.45
Peptide content (%w/w)	not stated	86.88
Endotoxin (EU/mg)	not stated	not determined
Method stated on certificate	NO	—	no method section — the result cannot be reconciled against any other

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: Domestic warehouse despatch → submitter (2–8 °C, 18 d) → laboratory (courier, cold pack, 9 d) → assay.
Assay date: 17 Jul 2024
Submitted to the index: 12 Aug 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

No annotations on this record. Annotations are short signed technical comments from index contributors; see how to contribute.

Section 7

Related records

Same batch — lot GLBI-2404-U8654 n=9

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2024-005282	GLBI-2404-U8654	Janoshik	2024-Q3	98.88	7.45	—	Supplier-supplied	2	MARGINAL
AX-2024-005284	GLBI-2404-U8654	Medutest	2024-Q3	98.19	7.50	100.1	Supplier-supplied	2	FAIL
AX-2024-005285	GLBI-2404-U8654	Janoshik	2024-Q3	99.01	7.30	94.7	Supplier-supplied	2	MARGINAL
AX-2024-005286	GLBI-2404-U8654	Janoshik	2024-Q3	99.57	7.40	101.5	Supplier-supplied	2	MARGINAL
AX-2024-005287	GLBI-2404-U8654	Nordanalyt	2024-Q3	99.01	6.81	98.1	Supplier-supplied	3	MARGINAL
AX-2024-005288	GLBI-2404-U8654	Medutest	2024-Q3	99.12	7.54	96.0	Supplier-supplied	2	MARGINAL
AX-2024-005289	GLBI-2404-U8654	PeptideMeter	2024-Q3	98.65	7.70	—	Supplier-supplied	2	MARGINAL
AX-2024-005290	GLBI-2404-U8654	PeptideMeter	2024-Q3	98.90	7.66	—	Supplier-supplied	2	MARGINAL

Batch rollup and reproducibility assessment →

Cross-sections

Other recent Semax records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042368	HJ	HJ-2603-V4363	Nordanalyt	2026-Q3	99.17	7.26	106.3	Supplier-supplied	1	MARGINAL
AX-2026-042367	HJ	HJ-2603-V4363	Kestrel	2026-Q3	99.10	6.78	93.9	Supplier-supplied	1	MARGINAL
AX-2026-042260	Homopeptide	HOMO-2605-S1342	Medutest	2026-Q3	99.44	6.06	92.4	Laboratory-retained	1	FAIL
AX-2026-042370	HJ	HJ-2603-V4363	Janoshik	2026-Q3	98.94	7.16	104.0	Supplier-supplied	1	MARGINAL
AX-2026-042369	HJ	HJ-2603-V4363	Janoshik	2026-Q3	99.26	7.67	95.0	Supplier-supplied	1	MARGINAL
AX-2026-041947	TFC	TFC-2602-F4591	Nordanalyt	2026-Q2	99.29	8.98	92.3	Supplier-supplied	0	PASS
AX-2026-041940	TFC	TFC-2602-F4591	Janoshik	2026-Q2	99.06	8.38	98.8	Buyer-sourced	0	PASS
AX-2026-043141	SSA	SSA-2604-L7628	Kestrel	2026-Q2	98.84	8.58	93.2	Supplier-supplied	2	MARGINAL

Other recent GL Biochem records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043176	Kisspeptin-10	GLBI-2608-N8085	Medutest	2026-Q3	98.22	3.30	92.5	Buyer-sourced	2	FAIL
AX-2026-043180	Kisspeptin-10	GLBI-2608-N8085	Janoshik	2026-Q3	98.69	3.37	103.8	Supplier-supplied	2	MARGINAL
AX-2026-043178	Kisspeptin-10	GLBI-2608-N8085	Janoshik	2026-Q3	98.24	4.44	96.0	Supplier-supplied	2	FAIL
AX-2026-043177	Kisspeptin-10	GLBI-2608-N8085	Janoshik	2026-Q3	98.31	3.87	106.5	Buyer-sourced	2	FAIL
AX-2026-043202	Semaglutide	GLBI-2602-U8631	PeptideMeter	2026-Q3	96.77	6.38	89.7	Supplier-supplied	3	FAIL
AX-2026-043174	Kisspeptin-10	GLBI-2608-N8085	Medutest	2026-Q3	98.18	4.09	—	Laboratory-retained	2	FAIL
AX-2026-043201	Semaglutide	GLBI-2602-U8631	Janoshik	2026-Q3	96.91	5.77	91.2	Supplier-supplied	2	FAIL
AX-2026-043203	Semaglutide	GLBI-2602-U8631	Medutest	2026-Q3	97.45	6.09	—	Supplier-supplied	2	MARGINAL