AssayIndex

AX-2026-042475

PT-141 (Bremelanotide) · 10 mg declared · Hunan Aslsen Technology Co., Ltd. · lot HOMO-2512-V4503

PASSMETHOD LIMITED
Report ID
AX-2026-042475
Compound
PT-141 (Bremelanotide)
Compound class
Melanocortin-receptor peptides
Supplier
Homopeptide — Hunan Aslsen Technology Co., Ltd.
Batch / lot
HOMO-2512-V4503
Declared label claim
10mg
Laboratory
Kestrel Bioanalytical
Assay date
04 Mar 2026
Submitted
07 Mar 2026
Quarter
2026-Q1
Submitter
f.grimaldi
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.

ParameterMethodResultUnitIndex spec
PurityRP-HPLC, 15 min gradient, 214 nm99.93% area≥ 98.5PASS
Total impuritiesRP-HPLC, sum of reported peaks0.07% area≤ 1.5PASS
Largest single impurityRP-HPLC — des-acetyl (−42 Da)0.04% area≤ 1.00PASS
Identitynot ordered on this submissionnot determinedrequired for VERIFIED statusNOT TESTED
Total peptide contentby difference from the gravimetric mass balance90.91%w/wNOT TESTED
Target-compound contenttotal peptide content × purity90.85%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen11.42mg10 mg declaredNOT TESTED
Recovered target peptidegross fill × target content10.375mg10 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim103.8%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate4.52%≤ 8.0PASS
Counter-ion (acetate)anion-exchange ion chromatography4.05%≤ 10.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.52%NOT TESTED
Endotoxinkinetic chromogenic LAL0.27EU/mg≤ 5.0PASS
Sterilitynot ordered on this submissionnot determinedno growthNOT TESTED
Appearancevisual, diffuse light, black and white backgroundWhite cake, partial shrinkage from vial wallwhite to off-white intact cakeFAIL
Reconstitution clarityreconstituted per submitter procedureClear, colourless, no visible particulatesclear, no visible particulatesPASS
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration5.482.5 – 8.0PASS
Retention time (observed)RP-HPLC, 15 min gradient5.23min5.14 ± 0.25 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.190.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²72,590≥ 20,000PASS
Resolution to nearest impurityvs des-acetyl (−42 Da)2.89no index criterionREPORTED
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.

05442108841632621768 PT-141 (Bremelanotide)5.23 min · 99.93 % 5.00 same trace · ×200 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 048121620 Retention time (min) Response (mAU)
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 72,590, and skew follows the reported asymmetry factor of 1.19. 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.
#PeakRTArea (µV·s)% areaΔ mass (Da)
1PT-141 (Bremelanotide) — main peak5.234,856,90899.93
2des-acetyl (−42 Da)5.001,9440.04-42.011
3linear precursor (+18 Da)4.881,4580.03+18.011
Closure check — purity + Σ impurities 100.00CLOSES

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.

ComponentDetermination%w/w of cake
WaterKarl Fischer4.52
Counter-ion (acetate)ion chromatography4.05
Residual solvent + inorganic residueestimated0.52
Total peptide contentby difference90.91
Total100.00 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.

FigureSupplier COAThis reportIndex note
Purity (% area)99.9099.93divergence -0.03 pp vs batch median
Total impurities (% area)0.100.07
Largest single impurity (% area)0.040.04
Water (%)3.84.52
Counter-ion (%)not stated4.05
Peptide content (%w/w)not stated90.91
Endotoxin (EU/mg)0.260.27
Method stated on certificateYEScolumn, 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 (−20 °C, 31 d) → laboratory (courier, dry ice, 8 d) → assay.
Assay date
04 Mar 2026
Submitted to the index
07 Mar 2026
Laboratory
Kestrel Bioanalytical, Melbourne, Australia
Method basis
15 min gradient · unit-resolution MS
Verification status
METHOD LIMITED
Section 6

Annotations 2

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.

peak_integrator
Purity at 99.93 % and water at 4.52 %: the two numbers are independent and both are needed. Excellent chromatography on a wet cake still yields less peptide per vial than the label implies.
The species that would matter here is mass-identical to the target, so no mass spectrum excludes it and no purity figure at 15 min quantifies it. The compound page states the resolution achievable and this method is not it.
Section 7

Related records

Same batch — lot HOMO-2512-V4503 n=1

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

Other recent PT-141 (Bremelanotide) records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041471QYBQYB-2607-L4875Janoshik2026-Q399.723.75101.7Buyer-sourced0PASS
AX-2026-041473QYBQYB-2607-L4875PeptideMeter2026-Q399.583.7494.4Buyer-sourced0PASS
AX-2026-041472QYBQYB-2607-L4875PeptideMeter2026-Q399.933.94Buyer-sourced0PASS
AX-2026-041474QYBQYB-2607-L4875VendorInvestigate2026-Q399.163.7895.6Buyer-sourced0PASS
AX-2026-041470QYBQYB-2607-L4875Janoshik2026-Q399.774.10Buyer-sourced0PASS
AX-2026-042139JEEPJEEP-2601-K8195VendorInvestigate2026-Q298.324.2999.4Buyer-sourced1FAIL
AX-2026-041964AMBAMB-2601-M5602Janoshik2026-Q299.933.20Buyer-sourced0PASS
AX-2026-041664FGPFGP-2602-Y8741Janoshik2026-Q299.904.48106.5Buyer-sourced0PASS
Other recent Homopeptide records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042437RetatrutideHOMO-2605-V4718Nordanalyt2026-Q398.683.67102.8Buyer-sourced0PASS
AX-2026-042424SemaglutideHOMO-2604-X3806PeptideMeter2026-Q398.854.8792.0Buyer-sourced0PASS
AX-2026-042503IGF-1 LR3HOMO-2607-P5131Janoshik2026-Q399.365.99Buyer-sourced0PASS
AX-2026-042492SS-31 (Elamipretide)HOMO-2604-D5484Medutest2026-Q399.932.40Buyer-sourced0PASS
AX-2026-042491SS-31 (Elamipretide)HOMO-2604-D5484Kestrel2026-Q399.933.24Supplier-supplied0PASS
AX-2026-042473LL-37HOMO-2602-G5165Janoshik2026-Q399.015.00Buyer-sourced0PASS
AX-2026-042441RetatrutideHOMO-2605-V4718Medutest2026-Q398.934.22Buyer-sourced0PASS
AX-2026-042474LL-37HOMO-2602-G5165Janoshik2026-Q399.185.44Buyer-sourced0PASS