AX-2026-042476

Afamelanotide · 10 mg declared · Hunan Aslsen Technology Co., Ltd. · lot HOMO-2511-V4580

FAILPURITY ONLY

Report ID: AX-2026-042476
Compound: Afamelanotide
Compound class: Melanocortin-receptor peptides
Supplier: Homopeptide — Hunan Aslsen Technology Co., Ltd.
Batch / lot: HOMO-2511-V4580
Declared label claim: 10mg
Laboratory: Nordanalyt Laboratories
Assay date: 16 Feb 2026
Submitted: 08 Mar 2026
Quarter: 2026-Q1
Submitter: l.rautio
Sample provenance: Buyer-sourced

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, 35 min gradient, 214 nm	99.38	% area	≥ 98.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.62	% area	≤ 2.0	PASS
Largest single impurity	RP-HPLC — native α-MSH (−32 Da)	0.27	% 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	5.41	%	≤ 8.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	2.99	%	≤ 10.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.32	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	11.42	EU/mg	≤ 5.0	FAIL
Sterility	not ordered on this submission	not determined	—	no growth	NOT TESTED
Appearance	visual, diffuse light, black and white background	White cake, partial shrinkage from vial wall	—	white to off-white intact cake	FAIL
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	5.42	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 35 min gradient	12.44	min	12.53 ± 0.30 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.35	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	76,033	—	≥ 20,000	PASS
Resolution to nearest impurity	vs oxidised Trp (+16 Da)	2.40	—	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 76,033, and skew follows the reported asymmetry factor of 1.35. 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 0.27 % impurity against a 99.38 % 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	12.44	4,830,176	99.38	—
2	native α-MSH (−32 Da)	11.67	13,123	0.27	-32.037
3	des-acetyl (−42 Da)	11.83	11,179	0.23	-42.011
4	Met sulfoxide (+16 Da)	11.93	2,916	0.06	+15.995
5	oxidised Trp (+16 Da)	12.00	2,916	0.06	+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 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)	99.82	99.38	divergence +0.44 pp vs batch median
Total impurities (% area)	not stated	0.62
Largest single impurity (% area)	not stated	0.27
Water (%)	5.2	5.41
Counter-ion (%)	not stated	2.99
Peptide content (%w/w)	not stated	not determined
Endotoxin (EU/mg)	not stated	11.42
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: Retail purchase → submitter (ambient, 18 d) → laboratory (hand-carried, 11 d) → assay.
Assay date: 16 Feb 2026
Submitted to the index: 08 Mar 2026
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 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.

diode_array08 Mar 2026

Photodiode-array spectral homogeneity across the main peak would convert 99.38 % from a good number into a checked one. It is a free measurement on any instrument that already has the detector.

gradient_2508 Mar 2026

The gradient is on the record, which is the first thing that should be true of any purity figure and often is not. 35 min at Nordanalyt puts this comparison on a documented footing.

lot_traceability08 Mar 2026

Lot HOMO-2511-V4580 decodes to a manufacture date consistent with the custody chain above. Traceability plus 99.38 % is a complete story; either alone is half of one.

oxidation_ladder08 Mar 2026

Photo-oxidation and thermal oxidation produce overlapping but distinguishable product distributions. Where both a Met and a Trp product are present, light is implicated more strongly than temperature.

Section 7

Related records

Same batch — lot HOMO-2511-V4580 n=1

This is the only report on this lot. One report is not a batch characterisation.

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-2026-042457	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
AX-2025-020674	SGN	SGN-2510-R8306	Janoshik	2025-Q4	98.22	5.36	—	Buyer-sourced	0	PASS

Other recent Homopeptide records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2026-042437	Retatrutide	HOMO-2605-V4718	Nordanalyt	2026-Q3	98.68	3.67	102.8	Buyer-sourced	PASS
AX-2026-042424	Semaglutide	HOMO-2604-X3806	PeptideMeter	2026-Q3	98.85	4.87	92.0	Buyer-sourced	PASS
AX-2026-042503	IGF-1 LR3	HOMO-2607-P5131	Janoshik	2026-Q3	99.36	5.99	—	Buyer-sourced	PASS
AX-2026-042492	SS-31 (Elamipretide)	HOMO-2604-D5484	Medutest	2026-Q3	99.93	2.40	—	Buyer-sourced	PASS
AX-2026-042491	SS-31 (Elamipretide)	HOMO-2604-D5484	Kestrel	2026-Q3	99.93	3.24	—	Supplier-supplied	PASS
AX-2026-042473	LL-37	HOMO-2602-G5165	Janoshik	2026-Q3	99.01	5.00	—	Buyer-sourced	PASS
AX-2026-042441	Retatrutide	HOMO-2605-V4718	Medutest	2026-Q3	98.93	4.22	—	Buyer-sourced	PASS
AX-2026-042474	LL-37	HOMO-2602-G5165	Janoshik	2026-Q3	99.18	5.44	—	Buyer-sourced	PASS