AX-2024-005312 · Afamelanotide · BCH lot BCH-2310-K5538

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	97.83	% area	≥ 98.0	FAIL
Total impurities	RP-HPLC, sum of reported peaks	2.17	% area	≤ 2.0	FAIL
Largest single impurity	RP-HPLC — Met sulfoxide (+16 Da)	0.82	% 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)	1645.8392	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	-5.0	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	92.16	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	90.16	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	11.08	mg	10 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	9.990	mg	10 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	99.9	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	4.35	%	≤ 8.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	3.06	%	≤ 10.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.43	%	—	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, colourless, no visible particulates	—	clear, no visible particulates	PASS
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	5.18	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	10.77	min	10.86 ± 0.30 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.07	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	78,586	—	≥ 20,000	PASS
Resolution to nearest impurity	vs oxidised Trp (+16 Da)	2.41	—	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 78,586, and skew follows the reported asymmetry factor of 1.07. 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 0.82 % impurity against a 97.83 % 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	10.77	4,754,841	97.83	—
2	Met sulfoxide (+16 Da)	10.33	39,855	0.82	+15.995
3	des-acetyl (−42 Da)	10.25	37,910	0.78	-42.011
4	oxidised Trp (+16 Da)	10.39	17,983	0.37	+15.995
5	native α-MSH (−32 Da)	10.11	9,721	0.20	-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 1645.8392 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	412.4671	-0.0020	7.7
3+	549.6231	549.6203	-0.0028	54.4
2+	823.9310	823.9269	-0.0041	100.0
1+	1646.8547	1646.8465	-0.0082	56.1

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	4.35
Counter-ion (acetate)	ion chromatography	3.06
Residual solvent + inorganic residue	estimated	0.43
Total peptide content	by difference	92.16
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)	97.74	97.83	divergence -0.12 pp vs batch median
Total impurities (% area)	not stated	2.17
Largest single impurity (% area)	not stated	0.82
Water (%)	4.2	4.35
Counter-ion (%)	not stated	3.06
Peptide content (%w/w)	not stated	92.16
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: Domestic warehouse despatch → submitter (2–8 °C, 31 d) → laboratory (courier, cold pack, 5 d) → assay.
Assay date: 28 Feb 2024
Submitted to the index: 02 Mar 2024
Laboratory: Janoshik Analytical, Ostrava, Czechia
Method basis: 30 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 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.

units_pedant02 Mar 2024

Reported as signed ppm, which is the right convention: direction carries information about calibration that a modulus discards.

iso_audit02 Mar 2024

A certification says what a process is supposed to do. A retail vial says what it did. Both are worth having and only one of them is a measurement.

Section 7

Related records

Same batch — lot BCH-2310-K5538 n=7

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2024-005310	BCH-2310-K5538	Nordanalyt	2024-Q1	98.13	5.34	104.9	Buyer-sourced	0	PASS
AX-2024-005311	BCH-2310-K5538	Janoshik	2024-Q1	97.80	5.42	90.0	Buyer-sourced	0	FAIL
AX-2024-005313	BCH-2310-K5538	Kestrel	2024-Q1	98.87	5.62	107.3	Buyer-sourced	0	PASS
AX-2024-005314	BCH-2310-K5538	Janoshik	2024-Q1	97.86	6.00	100.4	Buyer-sourced	0	FAIL
AX-2024-005315	BCH-2310-K5538	Janoshik	2024-Q1	98.10	5.68	—	Buyer-sourced	0	PASS
AX-2024-005316	BCH-2310-K5538	PeptideMeter	2024-Q1	97.57	5.14	—	Buyer-sourced	1	FAIL

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 BCH records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043445	BPC-157	BCH-2603-G4350	Nordanalyt	2026-Q3	98.42	4.87	93.6	Buyer-sourced	1	MARGINAL
AX-2026-043440	BPC-157	BCH-2603-G4350	VendorInvestigate	2026-Q3	98.61	4.11	—	Buyer-sourced	1	MARGINAL
AX-2026-043442	BPC-157	BCH-2603-G4350	Janoshik	2026-Q3	98.65	4.78	—	Buyer-sourced	1	MARGINAL
AX-2026-043471	CJC-1295 with DAC	BCH-2607-H5235	Janoshik	2026-Q3	97.46	5.48	—	Buyer-sourced	1	FAIL
AX-2026-043477	CJC-1295 with DAC	BCH-2607-H5235	VendorInvestigate	2026-Q3	97.62	5.32	99.6	Buyer-sourced	1	MARGINAL
AX-2026-043449	BPC-157	BCH-2603-G4350	Kestrel	2026-Q3	99.74	4.92	91.3	Supplier-supplied	2	MARGINAL
AX-2026-043448	BPC-157	BCH-2603-G4350	Janoshik	2026-Q3	98.55	4.69	106.9	Buyer-sourced	1	MARGINAL
AX-2026-043470	CJC-1295 with DAC	BCH-2607-H5235	Janoshik	2026-Q3	97.76	6.11	99.3	Supplier-supplied	1	MARGINAL