AX-2024-005296 · PT-141 (Bremelanotide) · GL Biochem lot GLBI-2402-T8589

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	98.67	% area	≥ 98.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	1.33	% area	≤ 1.5	PASS
Largest single impurity	RP-HPLC — linear precursor (+18 Da)	0.67	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	1024.5242	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, high resolution (ESI-TOF/QTOF)	1024.5270	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+2.7	ppm	± 15	PASS
Peptide content	not ordered on this submission	not determined	—	required to check label claim	NOT TESTED
Water content	Karl Fischer, coulometric, duplicate	4.48	%	≤ 8.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	6.18	%	≤ 10.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	1.00	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	8.03	EU/mg	≤ 5.0	FAIL
Sterility	membrane filtration, USP <71>, 14 d	No growth at 14 d	—	no growth	PASS
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 after 90 s gentle swirling, no particulates	—	clear, no visible particulates	PASS
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	6.02	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	9.46	min	9.52 ± 0.25 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.06	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	45,370	—	≥ 20,000	PASS
Resolution to nearest impurity	vs melanotan II (C-terminal amide, −1 Da)	1.76	—	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 45,370, and skew follows the reported asymmetry factor of 1.06. 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 0.67 % impurity against a 98.67 % 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	9.46	4,795,668	98.67	—
2	linear precursor (+18 Da)	8.76	32,564	0.67	+18.011
3	melanotan II (C-terminal amide, −1 Da)	9.78	21,871	0.45	-0.984
4	oxidised Trp (+16 Da)	9.12	6,804	0.14	+15.995
5	des-acetyl (−42 Da)	9.00	3,402	0.07	-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 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, high-resolution instrument. Sticks are placed at m/z = (M + z × 1.007276)/z for the observed neutral mass of 1024.5270 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	342.5163	0.0010	8.8
2+	513.2694	513.2708	0.0014	52.3
1+	1025.5315	1025.5343	0.0028	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.

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)	99.0	98.67	divergence +0.34 pp vs batch median
Total impurities (% area)	1.00	1.33
Largest single impurity (% area)	0.40	0.67
Water (%)	not stated	4.48
Counter-ion (%)	not stated	6.18
Peptide content (%w/w)	not stated	not determined
Endotoxin (EU/mg)	5.51	8.03
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: Supplier-supplied
Evidentiary weight: Weaker evidence. Read with the caveat below.
Chain of custody: Supplier despatch → laboratory direct (courier, cold pack, 11 d) → assay. Submitter did not handle the vial.
Assay date: 04 Aug 2024
Submitted to the index: 26 Aug 2024
Laboratory: Janoshik Analytical, Ostrava, Czechia
Method basis: 30 min gradient · high-resolution MS
Verification status: VERIFIED

What this report does not establish

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 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.

thin_coverage26 Aug 2024

Endotoxin determined but the LAL method is not stated. Kinetic chromogenic and gel-clot give different results and different sensitivity. The value cannot be interpreted without knowing which.

cjc_maleimide26 Aug 2024

No endotoxin figure on this record, which is true of roughly three quarters of the index. It is the one measurement that cannot be inferred from any other and the one most often omitted.

dedupe_logic26 Aug 2024

Endotoxin undetectable means below the detection limit of on Janoshik's system. That does not mean zero and may not reflect actual endotoxin. The cutoff is useful for screening; the absence of a number is not a guarantee.

exenatide_sulfox26 Aug 2024

8.03 EU/mg is at the sensitivity limit of Janoshik's LAL method. The true value is unspecified; treating this as a point estimate is overstating precision.

Section 7

Related records

Same batch — lot GLBI-2402-T8589 n=7

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2024-005291	GLBI-2402-T8589	Nordanalyt	2024-Q3	98.08	5.06	—	Supplier-supplied	2	FAIL
AX-2024-005292	GLBI-2402-T8589	Janoshik	2024-Q3	98.66	4.86	—	Supplier-supplied	2	MARGINAL
AX-2024-005293	GLBI-2402-T8589	Medutest	2024-Q3	98.35	5.16	—	Buyer-sourced	2	FAIL
AX-2024-005294	GLBI-2402-T8589	Janoshik	2024-Q3	98.37	4.85	100.9	Supplier-supplied	2	FAIL
AX-2024-005295	GLBI-2402-T8589	Kestrel	2024-Q3	99.23	4.63	100.3	Supplier-supplied	2	MARGINAL
AX-2024-005297	GLBI-2402-T8589	Medutest	2024-Q3	98.77	4.84	—	Supplier-supplied	2	MARGINAL

Batch rollup and reproducibility assessment →

Cross-sections

All PT-141 (Bremelanotide) records n=200
All GL Biochem records n=126
All Janoshik records n=3159
All 2024-Q3 records n=522
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	Result
AX-2026-041488	QYB	QYB-2607-L5615	Janoshik	2026-Q3	99.93	3.79	—	Supplier-supplied	PASS
AX-2026-041483	QYB	QYB-2607-L5615	Janoshik	2026-Q3	99.93	3.87	—	Supplier-supplied	PASS
AX-2026-041482	QYB	QYB-2607-L5615	PeptideMeter	2026-Q3	99.41	3.97	—	Supplier-supplied	PASS
AX-2026-041489	QYB	QYB-2607-L5615	PeptideMeter	2026-Q3	99.40	4.39	90.1	Supplier-supplied	PASS
AX-2026-041480	QYB	QYB-2607-L5615	Medutest	2026-Q3	99.93	4.32	100.5	Supplier-supplied	PASS
AX-2026-041481	QYB	QYB-2607-L5615	Kestrel	2026-Q3	99.93	3.63	100.5	Supplier-supplied	PASS
AX-2026-041487	QYB	QYB-2607-L5615	Nordanalyt	2026-Q3	99.43	4.03	—	Supplier-supplied	PASS
AX-2026-041486	QYB	QYB-2607-L5615	Nordanalyt	2026-Q3	99.62	3.82	104.9	Supplier-supplied	PASS

Other recent GL Biochem records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043176	Kisspeptin-10	GLBI-2608-N8085	Medutest	2026-Q3	98.22	3.30	92.5	Buyer-sourced	2	FAIL
AX-2026-043180	Kisspeptin-10	GLBI-2608-N8085	Janoshik	2026-Q3	98.69	3.37	103.8	Supplier-supplied	2	MARGINAL
AX-2026-043178	Kisspeptin-10	GLBI-2608-N8085	Janoshik	2026-Q3	98.24	4.44	96.0	Supplier-supplied	2	FAIL
AX-2026-043177	Kisspeptin-10	GLBI-2608-N8085	Janoshik	2026-Q3	98.31	3.87	106.5	Buyer-sourced	2	FAIL
AX-2026-043202	Semaglutide	GLBI-2602-U8631	PeptideMeter	2026-Q3	96.77	6.38	89.7	Supplier-supplied	3	FAIL
AX-2026-043174	Kisspeptin-10	GLBI-2608-N8085	Medutest	2026-Q3	98.18	4.09	—	Laboratory-retained	2	FAIL
AX-2026-043201	Semaglutide	GLBI-2602-U8631	Janoshik	2026-Q3	96.91	5.77	91.2	Supplier-supplied	2	FAIL
AX-2026-043203	Semaglutide	GLBI-2602-U8631	Medutest	2026-Q3	97.45	6.09	—	Supplier-supplied	2	MARGINAL