AX-2025-019668

Afamelanotide · 10 mg declared · Tianjin Finder Chemical Co., Ltd. · lot TFC-2502-Y2346

MARGINALIDENTITY CONSISTENT

Report ID: AX-2025-019668
Compound: Afamelanotide
Compound class: Melanocortin-receptor peptides
Supplier: TFC — Tianjin Finder Chemical Co., Ltd.
Batch / lot: TFC-2502-Y2346
Declared label claim: 10mg
Laboratory: Janoshik Analytical
Assay date: 13 Mar 2025
Submitted: 04 Apr 2025
Quarter: 2025-Q1
Submitter: g.vasquez
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, 30 min gradient, 214 nm	99.13	% area	≥ 98.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.87	% area	≤ 2.0	PASS
Largest single impurity	RP-HPLC — Met sulfoxide (+16 Da)	0.31	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	1645.8474	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, high resolution (ESI-TOF/QTOF)	1645.8443	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	-1.9	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	5.02	%	≤ 8.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	2.71	%	≤ 10.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.63	%	—	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	4.96	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	10.89	min	10.86 ± 0.30 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.12	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	68,885	—	≥ 20,000	PASS
Resolution to nearest impurity	vs oxidised Trp (+16 Da)	2.23	—	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 68,885, and skew follows the reported asymmetry factor of 1.12. 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 0.31 % impurity against a 99.13 % 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	Afamelanotide — main peak	10.89	4,818,025	99.13	—
2	Met sulfoxide (+16 Da)	10.45	15,067	0.31	+15.995
3	des-acetyl (−42 Da)	10.37	12,151	0.25	-42.011
4	oxidised Trp (+16 Da)	10.51	10,207	0.21	+15.995
5	native α-MSH (−32 Da)	10.23	4,860	0.10	-32.037
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 1645.8474 Da, computed from C78H111N21O19. 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 1645.8443 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 (%)
4+	412.4691	412.4684	-0.0007	8.4
3+	549.6231	549.6220	-0.0011	58.5
2+	823.9310	823.9294	-0.0016	100.0
1+	1646.8547	1646.8516	-0.0031	60.7

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	99.13	divergence -0.23 pp vs batch median
Total impurities (% area)	not stated	0.87
Largest single impurity (% area)	not stated	0.31
Water (%)	3.0	5.02
Counter-ion (%)	not stated	2.71
Peptide content (%w/w)	not stated	not determined
Endotoxin (EU/mg)	not stated	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 (−20 °C, 4 d) → laboratory (courier, dry ice, 7 d) → assay.
Assay date: 13 Mar 2025
Submitted to the index: 04 Apr 2025
Laboratory: Janoshik Analytical, Ostrava, Czechia
Method basis: 30 min gradient · high-resolution MS
Verification status: IDENTITY CONSISTENT

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 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 3

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.

deamidation_rate04 Apr 2025

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.

sample_vs_retail04 Apr 2025

A retail vial at 99.13 % is worth more evidentially than a selected vial at a higher figure. That is the whole argument for recording provenance at all.

sole_source04 Apr 2025

On compounds with a single supplier, independently purchased records are the only thing preventing the evidence base from being entirely supplier-generated. They matter disproportionately there.

Section 7

Related records

Same batch — lot TFC-2502-Y2346 n=14

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-019655	TFC-2502-Y2346	PeptideMeter	2025-Q1	98.85	4.85	—	Laboratory-retained	1	MARGINAL
AX-2025-019656	TFC-2502-Y2346	Janoshik	2025-Q1	99.41	5.01	105.9	Buyer-sourced	1	MARGINAL
AX-2025-019657	TFC-2502-Y2346	VendorInvestigate	2025-Q1	99.47	4.61	—	Buyer-sourced	1	MARGINAL
AX-2025-019658	TFC-2502-Y2346	Medutest	2025-Q1	99.01	4.09	105.3	Buyer-sourced	1	MARGINAL
AX-2025-019659	TFC-2502-Y2346	PeptideMeter	2025-Q1	99.03	4.63	102.5	Laboratory-retained	1	MARGINAL
AX-2025-019660	TFC-2502-Y2346	Janoshik	2025-Q1	99.44	4.44	92.8	Buyer-sourced	1	MARGINAL
AX-2025-019661	TFC-2502-Y2346	Janoshik	2025-Q1	99.29	4.55	—	Buyer-sourced	1	MARGINAL
AX-2025-019662	TFC-2502-Y2346	VendorInvestigate	2025-Q1	99.32	4.74	106.0	Buyer-sourced	1	MARGINAL
AX-2025-019663	TFC-2502-Y2346	Janoshik	2025-Q1	99.28	5.01	—	Buyer-sourced	1	MARGINAL
AX-2025-019664	TFC-2502-Y2346	Janoshik	2025-Q1	99.00	4.98	102.8	Buyer-sourced	1	MARGINAL
AX-2025-019665	TFC-2502-Y2346	Janoshik	2025-Q1	99.18	4.77	99.2	Buyer-sourced	1	MARGINAL
AX-2025-019666	TFC-2502-Y2346	Medutest	2025-Q1	99.37	4.93	—	Buyer-sourced	1	MARGINAL
AX-2025-019667	TFC-2502-Y2346	Janoshik	2025-Q1	99.14	5.03	89.4	Buyer-sourced	2	MARGINAL

Batch rollup and reproducibility assessment →

Cross-sections

Other recent Afamelanotide records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043233	SGN	SGN-2602-Y9306	Janoshik	2026-Q3	98.76	4.02	92.2	Buyer-sourced	1	MARGINAL
AX-2026-043234	SGN	SGN-2602-Y9306	Kestrel	2026-Q3	99.93	4.16	—	Buyer-sourced	0	PASS
AX-2026-042342	TFC	TFC-2601-L2937	VendorInvestigate	2026-Q2	99.06	3.47	—	Laboratory-retained	0	PASS
AX-2026-042476	Homopeptide	HOMO-2511-V4580	Nordanalyt	2026-Q1	99.38	5.41	—	Buyer-sourced	1	FAIL
AX-2026-042457	Homopeptide	HOMO-2509-K4706	Janoshik	2026-Q1	99.21	4.94	89.6	Buyer-sourced	2	MARGINAL
AX-2026-041858	GSP	GSP-2508-U3747	Janoshik	2025-Q4	99.55	5.84	97.0	Buyer-sourced	0	PASS
AX-2025-020677	SGN	SGN-2510-R8306	VendorInvestigate	2025-Q4	98.01	4.92	97.5	Buyer-sourced	1	FAIL
AX-2025-020681	SGN	SGN-2510-R8306	PeptideMeter	2025-Q4	98.42	4.76	94.3	Buyer-sourced	0	PASS

Other recent TFC records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042265	Humanin (HNG)	TFC-2605-U1300	PeptideMeter	2026-Q3	99.52	6.31	—	Buyer-sourced	0	PASS
AX-2026-042222	SS-31 (Elamipretide)	TFC-2607-R9099	VendorInvestigate	2026-Q3	99.46	5.41	102.6	Buyer-sourced	0	PASS
AX-2026-042236	Humanin (HNG)	TFC-2608-S9940	Nordanalyt	2026-Q3	98.64	1.80	—	Buyer-sourced	0	PASS
AX-2026-042282	Retatrutide	TFC-2608-J1156	Janoshik	2026-Q3	98.54	4.27	—	Buyer-sourced	0	PASS
AX-2026-042226	SS-31 (Elamipretide)	TFC-2607-R9099	Janoshik	2026-Q3	99.62	5.47	—	Buyer-sourced	0	PASS
AX-2026-042217	Semaglutide	TFC-2604-X9037	PeptideMeter	2026-Q3	98.95	4.61	96.9	Buyer-sourced	0	PASS
AX-2026-042339	Sermorelin	TFC-2605-Y2176	Kestrel	2026-Q3	99.93	4.14	—	Supplier-supplied	1	FAIL
AX-2026-042214	Semaglutide	TFC-2604-X9037	Kestrel	2026-Q3	99.87	4.66	103.1	Laboratory-retained	0	PASS