AX-2024-004868

PT-141 (Bremelanotide) · 10 mg declared · Shanghai Wibson Biotechnology Co., Ltd. · lot SWB-2311-H6137

PASSVERIFIED

Report ID: AX-2024-004868
Compound: PT-141 (Bremelanotide)
Compound class: Melanocortin-receptor peptides
Supplier: SWB — Shanghai Wibson Biotechnology Co., Ltd.
Batch / lot: SWB-2311-H6137
Declared label claim: 10mg
Laboratory: Nordanalyt Laboratories
Assay date: 23 Apr 2024
Submitted: 07 May 2024
Quarter: 2024-Q2
Submitter: p.kowalski
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.

Parameter	Method	Result	Unit	Index spec
Purity	RP-HPLC, 35 min gradient, 214 nm	98.84	% area	≥ 98.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	1.16	% area	≤ 1.5	PASS
Largest single impurity	RP-HPLC — des-acetyl (−42 Da)	0.51	% 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)	1024.5255	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+1.3	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	90.35	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	89.30	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	11.52	mg	10 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	10.287	mg	10 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	102.9	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	3.51	%	≤ 8.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	5.50	%	≤ 10.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.64	%	—	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	Off-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	5.89	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 35 min gradient	10.88	min	10.98 ± 0.25 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	0.96	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	77,945	—	≥ 20,000	PASS
Resolution to nearest impurity	vs melanotan II (C-terminal amide, −1 Da)	2.34	—	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 77,945, and skew follows the reported asymmetry factor of 0.96. 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 0.51 % impurity against a 98.84 % 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	10.88	4,803,930	98.84	—
2	des-acetyl (−42 Da)	10.34	24,788	0.51	-42.011
3	melanotan II (C-terminal amide, −1 Da)	11.25	15,553	0.32	-0.984
4	linear precursor (+18 Da)	10.06	8,263	0.17	+18.011
5	oxidised Trp (+16 Da)	10.48	7,776	0.16	+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, high-resolution instrument. Sticks are placed at m/z = (M + z × 1.007276)/z for the observed neutral mass of 1024.5255 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	342.5158	0.0005	8.5
2+	513.2694	513.2700	0.0006	49.8
1+	1025.5315	1025.5328	0.0013	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	3.51
Counter-ion (acetate)	ion chromatography	5.50
Residual solvent + inorganic residue	estimated	0.64
Total peptide content	by difference	90.35
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)	99.66	98.84	divergence +0.56 pp vs batch median
Total impurities (% area)	not stated	1.16
Largest single impurity (% area)	not stated	0.51
Water (%)	2.5	3.51
Counter-ion (%)	8.8	5.50
Peptide content (%w/w)	88.1	90.35
Endotoxin (EU/mg)	0.31	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, 14 d) → laboratory (hand-carried, 11 d) → assay.
Assay date: 23 Apr 2024
Submitted to the index: 07 May 2024
Laboratory: Nordanalyt Laboratories, Uppsala, Sweden
Method basis: 35 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

No annotations on this record. Annotations are short signed technical comments from index contributors; see how to contribute.

Section 7

Related records

Same batch — lot SWB-2311-H6137 n=7

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2024-004866	SWB-2311-H6137	Janoshik	2024-Q2	99.21	3.18	97.4	Supplier-supplied	PASS
AX-2024-004867	SWB-2311-H6137	Janoshik	2024-Q2	98.89	3.46	93.6	Supplier-supplied	PASS
AX-2024-004869	SWB-2311-H6137	Nordanalyt	2024-Q2	99.25	3.93	—	Supplier-supplied	PASS
AX-2024-004870	SWB-2311-H6137	PeptideMeter	2024-Q2	98.53	3.24	100.0	Supplier-supplied	PASS
AX-2024-004871	SWB-2311-H6137	Medutest	2024-Q2	99.10	2.94	—	Supplier-supplied	PASS
AX-2024-004872	SWB-2311-H6137	Medutest	2024-Q2	99.35	3.37	—	Supplier-supplied	PASS

Batch rollup and reproducibility assessment →

Cross-sections

All PT-141 (Bremelanotide) records n=200
All SWB records n=317
All Nordanalyt records n=511
All 2024-Q2 records n=349
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 SWB records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042461	Kisspeptin-10	SWB-2603-D6238	Janoshik	2026-Q3	98.35	4.65	96.5	Supplier-supplied	3	FAIL
AX-2026-042479	Melanotan II	SWB-2603-A5707	Janoshik	2026-Q3	99.16	3.67	94.5	Supplier-supplied	1	MARGINAL
AX-2026-042481	Melanotan II	SWB-2603-A5707	Medutest	2026-Q3	98.95	3.37	90.8	Supplier-supplied	1	MARGINAL
AX-2026-042460	Kisspeptin-10	SWB-2603-D6238	Kestrel	2026-Q3	99.55	4.21	90.8	Supplier-supplied	3	MARGINAL
AX-2026-042483	Melanotan II	SWB-2603-A5707	Janoshik	2026-Q3	99.38	3.73	107.2	Supplier-supplied	1	MARGINAL
AX-2026-042398	Semaglutide	SWB-2602-X5278	Nordanalyt	2026-Q3	99.08	4.48	—	Supplier-supplied	1	MARGINAL
AX-2026-042399	Semaglutide	SWB-2602-X5278	Janoshik	2026-Q3	98.56	3.82	—	Supplier-supplied	1	MARGINAL
AX-2026-042499	BPC-157	SWB-2607-Y5787	Kestrel	2026-Q3	99.93	4.25	94.4	Supplier-supplied	0	PASS