AX-2026-043597 · Melanotan II · WXT lot WXT-2511-P5567

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	99.28	% area	≥ 98.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.72	% area	≤ 1.5	PASS
Largest single impurity	RP-HPLC — [L-Phe7]-diastereomer	0.40	% area	≤ 1.00	PASS
Identity	not ordered on this submission	not determined	—	required for VERIFIED status	NOT TESTED
Total peptide content	by difference from the gravimetric mass balance	89.92	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	89.27	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	9.95	mg	10 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	8.882	mg	10 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	88.8	%	90.0 – 110.0	FAIL
Water content	Karl Fischer, coulometric, duplicate	4.15	%	≤ 8.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	5.46	%	≤ 10.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.47	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	0.66	EU/mg	≤ 5.0	PASS
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	Faint haze, clearing on standing	—	clear, no visible particulates	FAIL
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	4.75	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 35 min gradient	11.46	min	11.35 ± 0.25 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.05	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	66,122	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [L-Phe7]-diastereomer	1.02	—	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 66,122, and skew follows the reported asymmetry factor of 1.05. 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 0.40 % impurity against a 99.28 % 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	Melanotan II — main peak	11.46	4,825,316	99.28	—
2	[L-Phe7]-diastereomer	11.27	19,441	0.40	0.000
3	linear (open-lactam) precursor (+18 Da)	10.60	7,290	0.15	+18.011
4	oxidised Trp (+16 Da)	11.04	4,374	0.09	+15.995
5	MT-II dimer (head-to-tail)	14.20	1,944	0.04	+1023.540
6	des-acetyl MT-II (−42 Da)	10.90	1,944	0.04	-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 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	4.15
Counter-ion (acetate)	ion chromatography	5.46
Residual solvent + inorganic residue	estimated	0.47
Total peptide content	by difference	89.92
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)	99.33	99.28	divergence -0.13 pp vs batch median
Total impurities (% area)	-0.16	0.72
Largest single impurity (% area)	not stated	0.40
Water (%)	not stated	4.15
Counter-ion (%)	not stated	5.46
Peptide content (%w/w)	91.7	89.92
Endotoxin (EU/mg)	not stated	0.66
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, 33 d) → laboratory (courier, ambient, 2 d) → assay.
Assay date: 06 Mar 2026
Submitted to the index: 15 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.
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.

chain_custody15 Mar 2026

Custody from checkout to injection is documented on this record. Provenance plus custody is what makes a single result generalise past the vial it came from.

valley_drop15 Mar 2026

The reported figure derives from the plate count and the retention gap, via the pharmacopoeial form with the sum of both peak widths in the denominator. It is a calculated quantity, not a measured one, and it inherits the plate count's uncertainty.

peak_integrator15 Mar 2026

Anyone comparing this purity figure against a result from a longer method should expect a difference of a few tenths in a predictable direction. The inter-lab page quantifies it per laboratory.

Section 7

Related records

Same batch — lot WXT-2511-P5567 n=8

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043594	WXT-2511-P5567	Janoshik	2026-Q1	99.38	4.20	—	Supplier-supplied	1	MARGINAL
AX-2026-043595	WXT-2511-P5567	Janoshik	2026-Q1	99.93	4.05	100.6	Supplier-supplied	1	MARGINAL
AX-2026-043596	WXT-2511-P5567	Janoshik	2026-Q1	99.54	4.20	—	Laboratory-retained	1	MARGINAL
AX-2026-043598	WXT-2511-P5567	Kestrel	2026-Q1	99.93	4.29	91.7	Buyer-sourced	1	MARGINAL
AX-2026-043599	WXT-2511-P5567	Janoshik	2026-Q1	99.13	4.10	100.1	Buyer-sourced	1	MARGINAL
AX-2026-043600	WXT-2511-P5567	Janoshik	2026-Q1	99.45	4.41	98.7	Buyer-sourced	1	MARGINAL
AX-2026-043601	WXT-2511-P5567	Nordanalyt	2026-Q1	99.46	3.63	—	Laboratory-retained	1	MARGINAL

Batch rollup and reproducibility assessment →

Cross-sections

Other recent Melanotan II records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2026-042691	SWB	SWB-2603-A7409	Kestrel	2026-Q3	99.60	4.39	90.5	Laboratory-retained	PASS
AX-2026-042692	SWB	SWB-2603-A7409	Janoshik	2026-Q3	99.73	3.66	94.9	Supplier-supplied	PASS
AX-2026-042687	SWB	SWB-2603-A7409	Nordanalyt	2026-Q3	99.05	4.33	—	Buyer-sourced	PASS
AX-2026-042693	SWB	SWB-2603-A7409	Janoshik	2026-Q3	99.93	4.63	—	Supplier-supplied	PASS
AX-2026-042686	SWB	SWB-2603-A7409	PeptideMeter	2026-Q3	99.69	4.52	—	Buyer-sourced	PASS
AX-2026-042685	SWB	SWB-2603-A7409	Janoshik	2026-Q3	99.03	4.35	—	Buyer-sourced	PASS
AX-2026-042694	SWB	SWB-2603-A7409	PeptideMeter	2026-Q3	99.21	3.84	—	Buyer-sourced	PASS
AX-2026-042684	SWB	SWB-2603-A7409	Janoshik	2026-Q3	99.01	3.41	—	Buyer-sourced	PASS

Other recent WXT records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043651	Pramlintide	WXT-2603-D6459	PeptideMeter	2026-Q3	98.21	4.97	101.6	Buyer-sourced	1	MARGINAL
AX-2026-043531	Leuprolide	WXT-2604-K4483	Medutest	2026-Q3	99.00	5.03	—	Buyer-sourced	0	PASS
AX-2026-043561	Semaglutide	WXT-2604-C5135	Janoshik	2026-Q3	96.96	4.22	91.3	Buyer-sourced	0	FAIL
AX-2026-043627	L-Glutathione (reduced)	WXT-2605-B5720	Janoshik	2026-Q3	97.96	6.08	92.3	Buyer-sourced	1	FAIL
AX-2026-043564	Semaglutide	WXT-2604-C5135	Janoshik	2026-Q3	97.15	4.44	104.7	Buyer-sourced	0	PASS
AX-2026-043533	Leuprolide	WXT-2604-K4483	PeptideMeter	2026-Q3	99.89	4.94	—	Supplier-supplied	0	PASS
AX-2026-043624	L-Glutathione (reduced)	WXT-2605-B5720	Nordanalyt	2026-Q3	98.18	6.95	105.3	Buyer-sourced	2	FAIL
AX-2026-043556	Semaglutide	WXT-2604-C5135	PeptideMeter	2026-Q3	97.56	4.35	89.6	Buyer-sourced	1	MARGINAL