AX-2026-042136 · PT-141 (Bremelanotide) · JEEP lot JEEP-2601-K8195

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, 15 min gradient, 214 nm	99.32	% area	≥ 98.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.68	% area	≤ 1.5	PASS
Largest single impurity	RP-HPLC — linear precursor (+18 Da)	0.28	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	1024.5242	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, unit resolution (single quadrupole)	1024.5285	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+4.2	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	90.03	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	89.42	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	11.83	mg	10 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	10.578	mg	10 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	105.8	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	3.93	%	≤ 8.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	5.49	%	≤ 10.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.55	%	—	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 powder, no defined cake (melt-back)	—	white to off-white intact cake	FAIL
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	5.62	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 15 min gradient	5.22	min	5.14 ± 0.25 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	0.98	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	63,559	—	≥ 20,000	PASS
Resolution to nearest impurity	vs melanotan II (C-terminal amide, −1 Da)	1.88	—	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, 15 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 63,559, and skew follows the reported asymmetry factor of 0.98. 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 0.28 % impurity against a 99.32 % 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	PT-141 (Bremelanotide) — main peak	5.22	4,827,260	99.32	—
2	linear precursor (+18 Da)	4.87	13,609	0.28	+18.011
3	melanotan II (C-terminal amide, −1 Da)	5.38	11,179	0.23	-0.984
4	des-acetyl (−42 Da)	4.99	4,860	0.10	-42.011
5	oxidised Trp (+16 Da)	5.05	3,402	0.07	+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 3

Mass spectrum and identity

Theoretical monoisotopic mass 1024.5242 Da, computed from C50H68N14O10. All ppm figures on this site are against monoisotopic values — see why that matters.

Figure 2. ESI charge-state envelope, unit-resolution instrument. Sticks are placed at m/z = (M + z × 1.007276)/z for the observed neutral mass of 1024.5285 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+	342.5153	342.5168	0.0015	8.1
2+	513.2694	513.2715	0.0021	51.7
1+	1025.5315	1025.5358	0.0043	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	3.93
Counter-ion (acetate)	ion chromatography	5.49
Residual solvent + inorganic residue	estimated	0.55
Total peptide content	by difference	90.03
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)	98.62	99.32	divergence +0.17 pp vs batch median
Total impurities (% area)	1.38	0.68
Largest single impurity (% area)	not stated	0.28
Water (%)	not stated	3.93
Counter-ion (%)	8.1	5.49
Peptide content (%w/w)	87.8	90.03
Endotoxin (EU/mg)	0.62	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: Retail purchase → submitter (ambient, 9 d) → laboratory (hand-carried, 10 d) → assay.
Assay date: 10 Jun 2026
Submitted to the index: 15 Jun 2026
Laboratory: Kestrel Bioanalytical, Melbourne, Australia
Method basis: 15 min gradient · unit-resolution MS
Verification status: METHOD LIMITED

What this report does not establish

That the compound is not a near-isobaric alternative. Identity was confirmed at unit mass resolution, which cannot exclude species differing by 1 or 2 Da. The specific alternatives not excluded are named in the identity block above.
That mass-identical impurities are absent. The gradient used is shorter than the index reference method and does not resolve the diastereomers named in the compound fingerprint. The purity figure is an upper bound.
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.

des_gly15 Jun 2026

At 99.32 % the deletion-sequence family is at or below the reporting threshold. On a sequence with a hindered coupling that is a statement about coupling efficiency, and a good one.

ms_confirm15 Jun 2026

Two instruments or it is not confirmed, and this record is one instrument. It is a good one instrument, and the index records it as confirmed rather than corroborated for that reason.

deamidation_rate15 Jun 2026

Deamidation adds one dalton, which at this mass is close to the resolution of the question rather than to the resolution of the instrument. The named-impurity table is the better place to look for it.

buyer_sourced15 Jun 2026

Independently purchased, at the submitter's own cost, forwarded without the supplier's involvement. That is the definition and this record meets it.

Section 7

Related records

Same batch — lot JEEP-2601-K8195 n=12

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042132	JEEP-2601-K8195	Medutest	2026-Q2	98.65	4.30	96.6	Buyer-sourced	1	MARGINAL
AX-2026-042133	JEEP-2601-K8195	Medutest	2026-Q2	98.95	4.23	—	Buyer-sourced	1	MARGINAL
AX-2026-042134	JEEP-2601-K8195	PeptideMeter	2026-Q2	98.32	4.62	92.4	Buyer-sourced	1	FAIL
AX-2026-042135	JEEP-2601-K8195	Janoshik	2026-Q2	98.44	4.64	—	Buyer-sourced	1	FAIL
AX-2026-042137	JEEP-2601-K8195	Janoshik	2026-Q2	98.12	3.79	104.8	Buyer-sourced	1	FAIL
AX-2026-042138	JEEP-2601-K8195	Medutest	2026-Q2	98.92	4.36	—	Buyer-sourced	1	MARGINAL
AX-2026-042139	JEEP-2601-K8195	VendorInvestigate	2026-Q2	98.32	4.29	99.4	Buyer-sourced	1	FAIL
AX-2026-042140	JEEP-2601-K8195	Janoshik	2026-Q2	98.28	3.89	—	Buyer-sourced	1	FAIL
AX-2026-042141	JEEP-2601-K8195	Janoshik	2026-Q2	98.45	4.16	—	Laboratory-retained	1	FAIL
AX-2026-042142	JEEP-2601-K8195	Medutest	2026-Q2	98.01	4.02	—	Buyer-sourced	1	FAIL
AX-2026-042143	JEEP-2601-K8195	PeptideMeter	2026-Q2	98.46	4.65	93.8	Buyer-sourced	1	FAIL

Batch rollup and reproducibility assessment →

Cross-sections

All PT-141 (Bremelanotide) records n=152
All JEEP records n=230
All Kestrel records n=407
All 2026-Q2 records n=1126
PT-141 (Bremelanotide) by supplier
PT-141 (Bremelanotide) impurity profile

Other recent PT-141 (Bremelanotide) records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041471	QYB	QYB-2607-L4875	Janoshik	2026-Q3	99.72	3.75	101.7	Buyer-sourced	0	PASS
AX-2026-041473	QYB	QYB-2607-L4875	PeptideMeter	2026-Q3	99.58	3.74	94.4	Buyer-sourced	0	PASS
AX-2026-041472	QYB	QYB-2607-L4875	PeptideMeter	2026-Q3	99.93	3.94	—	Buyer-sourced	0	PASS
AX-2026-041474	QYB	QYB-2607-L4875	VendorInvestigate	2026-Q3	99.16	3.78	95.6	Buyer-sourced	0	PASS
AX-2026-041470	QYB	QYB-2607-L4875	Janoshik	2026-Q3	99.77	4.10	—	Buyer-sourced	0	PASS
AX-2026-042139	JEEP	JEEP-2601-K8195	VendorInvestigate	2026-Q2	98.32	4.29	99.4	Buyer-sourced	1	FAIL
AX-2026-041964	AMB	AMB-2601-M5602	Janoshik	2026-Q2	99.93	3.20	—	Buyer-sourced	0	PASS
AX-2026-041664	FGP	FGP-2602-Y8741	Janoshik	2026-Q2	99.90	4.48	106.5	Buyer-sourced	0	PASS

Other recent JEEP records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042177	Hexarelin	JEEP-2608-Y9547	Janoshik	2026-Q3	99.90	3.42	—	Buyer-sourced	0	PASS
AX-2026-042162	Semaglutide	JEEP-2607-X9091	Janoshik	2026-Q3	98.98	3.46	—	Laboratory-retained	1	MARGINAL
AX-2026-042127	TB-500	JEEP-2602-V8614	Medutest	2026-Q3	99.68	3.55	—	Buyer-sourced	1	FAIL
AX-2026-042123	TB-500	JEEP-2602-V8614	PeptideMeter	2026-Q3	99.93	3.80	—	Buyer-sourced	0	PASS
AX-2026-042124	TB-500	JEEP-2602-V8614	PeptideMeter	2026-Q3	99.91	3.37	104.9	Buyer-sourced	0	PASS
AX-2026-042178	Hexarelin	JEEP-2608-Y9547	VendorInvestigate	2026-Q3	99.68	4.03	—	Buyer-sourced	0	PASS
AX-2026-042163	Semaglutide	JEEP-2607-X9091	Nordanalyt	2026-Q3	99.46	4.52	—	Buyer-sourced	1	MARGINAL
AX-2026-042122	TB-500	JEEP-2602-V8614	PeptideMeter	2026-Q3	99.60	3.58	97.0	Buyer-sourced	0	PASS