AX-2024-005399 · Melanotan II · PPG lot PPG-2408-L8298

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, 28 min gradient, 214 nm	99.93	% area	≥ 98.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.07	% area	≤ 1.5	PASS
Largest single impurity	RP-HPLC — des-acetyl MT-II (−42 Da)	0.04	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	1023.5402	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, high resolution (ESI-TOF/QTOF)	1023.5868	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+45.5	ppm	± 15	FAIL
Total peptide content	by difference from the gravimetric mass balance	88.64	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	88.58	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	11.45	mg	10 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	10.142	mg	10 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	101.4	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	4.81	%	≤ 8.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	5.67	%	≤ 10.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.88	%	—	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	Clear, colourless, no visible particulates	—	clear, no visible particulates	PASS
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	4.88	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 28 min gradient	9.16	min	9.24 ± 0.25 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.03	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	55,305	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [L-Phe7]-diastereomer	0.94	—	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, 28 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 55,305, and skew follows the reported asymmetry factor of 1.03. 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 0.04 % impurity against a 99.93 % 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	9.16	4,856,908	99.93	—
2	des-acetyl MT-II (−42 Da)	8.71	1,944	0.04	-42.011
3	[L-Phe7]-diastereomer	9.01	1,458	0.03	0.000
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 1023.5402 Da, computed from C50H69N15O9. 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 1023.5868 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 (%)
3+	342.1873	342.2029	0.0156	8.7
2+	512.7774	512.8007	0.0233	52.0
1+	1024.5475	1024.5941	0.0466	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	4.81
Counter-ion (acetate)	ion chromatography	5.67
Residual solvent + inorganic residue	estimated	0.88
Total peptide content	by difference	88.64
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)	99.82	99.93	divergence -0.10 pp vs batch median
Total impurities (% area)	0.18	0.07
Largest single impurity (% area)	not stated	0.04
Water (%)	4.4	4.81
Counter-ion (%)	3.0	5.67
Peptide content (%w/w)	92.0	88.64
Endotoxin (EU/mg)	1.54	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, 27 d) → laboratory (courier, cold pack, 5 d) → assay.
Assay date: 11 Nov 2024
Submitted to the index: 17 Nov 2024
Laboratory: PeptideMeter, Tallinn, Estonia
Method basis: 28 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.

c18_2p617 Nov 2024

Column chemistry flatters or punishes a figure like this. A core-shell column at this gradient resolves the close-eluting family that a fully porous 5 µm bed merges, so 99.93 % here is a harder number than the same figure from a coarser column.

peak_integrator17 Nov 2024

The resolution figure sits in the system-suitability block with no PASS or FAIL beside it. That is deliberate: the index reports it and adjudicates nothing against it.

endotoxin_limit17 Nov 2024

Everything else on this record reconciles: purity, water, counter-ion, and a closed mass balance where content was determined. One property is simply absent.

thin_coverage17 Nov 2024

The index would rather this page said nothing about endotoxin than said something unsupported. That is the standing editorial position and it is applied uniformly.

Section 7

Related records

Same batch — lot PPG-2408-L8298 n=8

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2025-021236	PPG-2408-L8298	Janoshik	2024-Q4	99.91	4.44	93.5	Laboratory-retained	PASS
AX-2024-005397	PPG-2408-L8298	Nordanalyt	2024-Q4	99.86	4.55	93.0	Buyer-sourced	PASS
AX-2025-021237	PPG-2408-L8298	VendorInvestigate	2024-Q4	99.78	4.32	91.4	Buyer-sourced	PASS
AX-2024-005398	PPG-2408-L8298	PeptideMeter	2024-Q4	99.93	4.89	99.5	Buyer-sourced	PASS
AX-2024-005400	PPG-2408-L8298	PeptideMeter	2024-Q4	99.93	4.78	—	Buyer-sourced	PASS
AX-2024-005401	PPG-2408-L8298	PeptideMeter	2024-Q4	99.66	4.61	93.0	Buyer-sourced	PASS
AX-2024-005402	PPG-2408-L8298	Nordanalyt	2024-Q4	99.93	4.60	105.2	Buyer-sourced	PASS

Batch rollup and reproducibility assessment →

Cross-sections

Other recent Melanotan II records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042757	GGPeps	GGPE-2603-P1474	Janoshik	2026-Q3	99.54	6.78	92.0	Buyer-sourced	0	PASS
AX-2026-042756	GGPeps	GGPE-2603-P1474	Nordanalyt	2026-Q3	99.17	7.04	—	Buyer-sourced	0	PASS
AX-2026-042755	GGPeps	GGPE-2603-P1474	Nordanalyt	2026-Q3	99.25	6.58	90.4	Buyer-sourced	0	PASS
AX-2026-042760	GGPeps	GGPE-2603-P1474	Medutest	2026-Q3	99.43	7.02	—	Buyer-sourced	0	PASS
AX-2026-042758	GGPeps	GGPE-2603-P1474	PeptideMeter	2026-Q3	99.23	6.96	—	Buyer-sourced	0	PASS
AX-2026-042759	GGPeps	GGPE-2603-P1474	Janoshik	2026-Q3	99.15	6.71	105.1	Buyer-sourced	0	PASS
AX-2026-042168	JEEP	JEEP-2604-R9103	Nordanalyt	2026-Q2	99.40	5.71	—	Buyer-sourced	0	PASS
AX-2026-042164	JEEP	JEEP-2604-R9103	Janoshik	2026-Q2	99.54	5.23	—	Buyer-sourced	1	MARGINAL

Other recent PPG records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043598	Tesamorelin	PPG-2608-A6835	Kestrel	2026-Q3	98.91	2.56	100.3	Buyer-sourced	1	FAIL
AX-2026-043597	Tesamorelin	PPG-2608-A6835	Janoshik	2026-Q3	98.54	1.15	—	Buyer-sourced	0	PASS
AX-2026-043596	Tesamorelin	PPG-2608-A6835	PeptideMeter	2026-Q3	98.74	1.83	105.1	Buyer-sourced	1	MARGINAL
AX-2026-043605	Retatrutide	PPG-2604-X7060	Janoshik	2026-Q2	98.17	4.29	99.7	Buyer-sourced	0	PASS
AX-2026-043601	Retatrutide	PPG-2604-X7060	Janoshik	2026-Q2	98.28	3.96	95.3	Buyer-sourced	0	PASS
AX-2026-043668	AOD-9604	PPG-2602-W8018	PeptideMeter	2026-Q2	99.47	3.06	—	Buyer-sourced	0	PASS
AX-2026-043670	AOD-9604	PPG-2602-W8018	PeptideMeter	2026-Q2	99.56	2.71	104.5	Buyer-sourced	0	PASS
AX-2026-043630	CJC-1295 (no DAC)	PPG-2512-D7211	Janoshik	2026-Q2	99.66	5.11	92.5	Buyer-sourced	0	PASS