AX-2025-020680 · Afamelanotide · SGN lot SGN-2510-R8306

Section 1

Results

Measured against the index acceptance specification for the melanocortin-receptor 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	98.20	% area	≥ 98.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	1.80	% area	≤ 2.0	PASS
Largest single impurity	RP-HPLC — Met sulfoxide (+16 Da)	1.19	% area	≤ 1.00	FAIL
Identity — theoretical monoisotopic mass	calculated from molecular formula	1645.8474	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, high resolution (ESI-TOF/QTOF)	1645.9116	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+39.0	ppm	± 15	FAIL
Total peptide content	by difference from the gravimetric mass balance	90.94	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	89.30	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	10.19	mg	10 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	9.100	mg	10 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	91.0	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	5.66	%	≤ 8.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	3.13	%	≤ 10.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.27	%	—	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 after 90 s gentle swirling, no particulates	—	clear, no visible particulates	PASS
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	4.17	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	10.79	min	10.86 ± 0.30 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.20	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	93,161	—	≥ 20,000	PASS
Resolution to nearest impurity	vs oxidised Trp (+16 Da)	2.62	—	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 93,161, and skew follows the reported asymmetry factor of 1.20. 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 1.19 % impurity against a 98.20 % 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	Afamelanotide — main peak	10.79	4,772,824	98.20	—
2	Met sulfoxide (+16 Da)	10.35	57,838	1.19	+15.995
3	des-acetyl (−42 Da)	10.27	12,151	0.25	-42.011
4	oxidised Trp (+16 Da)	10.41	9,721	0.20	+15.995
5	native α-MSH (−32 Da)	10.13	7,776	0.16	-32.037
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 1645.8474 Da, computed from C78H111N21O19. 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 1645.9116 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 (%)
4+	412.4691	412.4852	0.0161	9.3
3+	549.6231	549.6445	0.0214	57.0
2+	823.9310	823.9631	0.0321	100.0
1+	1646.8547	1646.9189	0.0642	56.6

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	5.66
Counter-ion (acetate)	ion chromatography	3.13
Residual solvent + inorganic residue	estimated	0.27
Total peptide content	by difference	90.94
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)	98.92	98.20	divergence +0.55 pp vs batch median
Total impurities (% area)	1.08	1.80
Largest single impurity (% area)	0.37	1.19
Water (%)	not stated	5.66
Counter-ion (%)	not stated	3.13
Peptide content (%w/w)	not stated	90.94
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: Domestic warehouse despatch → submitter (2–8 °C, 8 d) → laboratory (courier, cold pack, 8 d) → assay.
Assay date: 13 Nov 2025
Submitted to the index: 21 Nov 2025
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 4

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.

quad_unit21 Nov 2025

Instrument class matters here. A unit-resolution determination reported to a tenth of a ppm is reporting a precision the hardware does not have, and +39.0 ppm on such a determination is largely noise.

survodutide_mixup21 Nov 2025

Where two catalogue compounds elute within half a minute of each other, mass is the discriminator and a mass you cannot trust leaves nothing. Retention at 10.79 min is doing more work on this record than usual.

iso_audit21 Nov 2025

A certification says what a process is supposed to do. A retail vial says what it did. Both are worth having and only one of them is a measurement.

ash_sulfated21 Nov 2025

Four slots — water, counter-ion, residual and peptide — are exhaustive and mutually exclusive. Anything that does not fit one of them is a fifth thing nobody measured, and on this record there is no remainder.

Section 7

Related records

Same batch — lot SGN-2510-R8306 n=9

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-020673	SGN-2510-R8306	Medutest	2025-Q4	98.46	4.90	93.6	Buyer-sourced	0	PASS
AX-2025-020674	SGN-2510-R8306	Janoshik	2025-Q4	98.22	5.36	—	Buyer-sourced	0	PASS
AX-2025-020675	SGN-2510-R8306	Medutest	2025-Q4	98.60	5.56	90.2	Buyer-sourced	0	PASS
AX-2025-020676	SGN-2510-R8306	Janoshik	2025-Q4	98.68	5.11	105.6	Buyer-sourced	0	PASS
AX-2025-020677	SGN-2510-R8306	VendorInvestigate	2025-Q4	98.01	4.92	97.5	Buyer-sourced	1	FAIL
AX-2025-020678	SGN-2510-R8306	Medutest	2025-Q4	98.34	5.62	103.2	Buyer-sourced	0	PASS
AX-2025-020679	SGN-2510-R8306	PeptideMeter	2025-Q4	98.37	5.55	—	Buyer-sourced	0	PASS
AX-2025-020681	SGN-2510-R8306	PeptideMeter	2025-Q4	98.42	4.76	94.3	Buyer-sourced	0	PASS

Batch rollup and reproducibility assessment →

Cross-sections

Other recent Afamelanotide records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043233	SGN	SGN-2602-Y9306	Janoshik	2026-Q3	98.76	4.02	92.2	Buyer-sourced	1	MARGINAL
AX-2026-043234	SGN	SGN-2602-Y9306	Kestrel	2026-Q3	99.93	4.16	—	Buyer-sourced	0	PASS
AX-2026-042342	TFC	TFC-2601-L2937	VendorInvestigate	2026-Q2	99.06	3.47	—	Laboratory-retained	0	PASS
AX-2026-042476	Homopeptide	HOMO-2511-V4580	Nordanalyt	2026-Q1	99.38	5.41	—	Buyer-sourced	1	FAIL
AX-2026-042457	Homopeptide	HOMO-2509-K4706	Janoshik	2026-Q1	99.21	4.94	89.6	Buyer-sourced	2	MARGINAL
AX-2026-041858	GSP	GSP-2508-U3747	Janoshik	2025-Q4	99.55	5.84	97.0	Buyer-sourced	0	PASS
AX-2025-020677	SGN	SGN-2510-R8306	VendorInvestigate	2025-Q4	98.01	4.92	97.5	Buyer-sourced	1	FAIL
AX-2025-020681	SGN	SGN-2510-R8306	PeptideMeter	2025-Q4	98.42	4.76	94.3	Buyer-sourced	0	PASS

Other recent SGN records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043233	Afamelanotide	SGN-2602-Y9306	Janoshik	2026-Q3	98.76	4.02	92.2	Buyer-sourced	1	MARGINAL
AX-2026-043234	Afamelanotide	SGN-2602-Y9306	Kestrel	2026-Q3	99.93	4.16	—	Buyer-sourced	0	PASS
AX-2026-043240	SLU-PP-332	SGN-2602-X9377	Janoshik	2026-Q2	98.82	5.46	97.0	Buyer-sourced	0	PASS
AX-2026-043222	ARA-290	SGN-2605-X9069	PeptideMeter	2026-Q2	98.32	7.36	—	Buyer-sourced	0	PASS
AX-2026-043237	SLU-PP-332	SGN-2602-X9377	Janoshik	2026-Q2	98.47	6.22	100.0	Supplier-supplied	0	PASS
AX-2026-043227	ARA-290	SGN-2605-X9069	PeptideMeter	2026-Q2	98.38	7.21	95.6	Buyer-sourced	0	PASS
AX-2026-043239	SLU-PP-332	SGN-2602-X9377	VendorInvestigate	2026-Q2	98.28	5.37	—	Buyer-sourced	0	PASS
AX-2026-043229	ARA-290	SGN-2605-X9069	Janoshik	2026-Q2	98.21	7.43	—	Buyer-sourced	0	PASS