AX-2024-005517

Afamelanotide · 10 mg declared · Bachem Holding (Suzhou) Co., Ltd. · lot BCH-2310-K7610

FAILIDENTITY CONSISTENT

Report ID: AX-2024-005517
Compound: Afamelanotide
Compound class: Melanocortin-receptor peptides
Supplier: BCH — Bachem Holding (Suzhou) Co., Ltd.
Batch / lot: BCH-2310-K7610
Declared label claim: 10mg
Laboratory: Janoshik Analytical
Assay date: 22 Jan 2024
Submitted: 31 Jan 2024
Quarter: 2024-Q1
Submitter: submit_more
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	97.39	% area	≥ 98.0	FAIL
Total impurities	RP-HPLC, sum of reported peaks	2.61	% area	≤ 2.0	FAIL
Largest single impurity	RP-HPLC — Met sulfoxide (+16 Da)	0.99	% 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)	1645.8439	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	-2.1	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	5.42	%	≤ 8.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	4.00	%	≤ 10.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.16	%	—	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 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	5.18	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	11.02	min	10.86 ± 0.30 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.16	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	64,962	—	≥ 20,000	PASS
Resolution to nearest impurity	vs oxidised Trp (+16 Da)	2.14	—	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 64,962, and skew follows the reported asymmetry factor of 1.16. 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 0.99 % impurity against a 97.39 % 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	11.02	4,733,456	97.39	—
2	Met sulfoxide (+16 Da)	10.58	48,117	0.99	+15.995
3	des-acetyl (−42 Da)	10.50	45,687	0.94	-42.011
4	oxidised Trp (+16 Da)	10.64	21,871	0.45	+15.995
5	native α-MSH (−32 Da)	10.36	11,179	0.23	-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 1645.8439 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	412.4683	-0.0008	8.4
3+	549.6231	549.6219	-0.0012	57.3
2+	823.9310	823.9292	-0.0018	100.0
1+	1646.8547	1646.8512	-0.0035	53.8

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)	98.26	97.39	divergence +0.29 pp vs batch median
Total impurities (% area)	1.74	2.61
Largest single impurity (% area)	0.64	0.99
Water (%)	4.0	5.42
Counter-ion (%)	not stated	4.00
Peptide content (%w/w)	91.2	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, 14 d) → laboratory (courier, dry ice, 5 d) → assay.
Assay date: 22 Jan 2024
Submitted to the index: 31 Jan 2024
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

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 BCH-2310-K7610 n=9

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2024-005513	BCH-2310-K7610	Janoshik	2024-Q1	98.16	5.48	100.9	Supplier-supplied	PASS
AX-2024-005514	BCH-2310-K7610	Janoshik	2024-Q1	98.24	4.96	104.8	Supplier-supplied	PASS
AX-2024-005515	BCH-2310-K7610	Nordanalyt	2024-Q1	97.72	5.54	91.9	Buyer-sourced	FAIL
AX-2024-005516	BCH-2310-K7610	Medutest	2024-Q1	98.24	4.54	—	Supplier-supplied	PASS
AX-2024-005518	BCH-2310-K7610	Medutest	2024-Q1	98.11	5.51	97.1	Supplier-supplied	PASS
AX-2024-005519	BCH-2310-K7610	Janoshik	2024-Q1	97.74	5.27	97.0	Supplier-supplied	FAIL
AX-2024-005520	BCH-2310-K7610	Nordanalyt	2024-Q1	97.87	5.45	91.4	Supplier-supplied	FAIL
AX-2024-005521	BCH-2310-K7610	Janoshik	2024-Q1	97.97	4.33	—	Supplier-supplied	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-2026-043215	SGN	SGN-2602-Y9898	PeptideMeter	2026-Q3	98.92	3.40	—	Supplier-supplied	1	MARGINAL
AX-2026-043214	SGN	SGN-2602-Y9898	Janoshik	2026-Q3	99.19	3.41	106.9	Supplier-supplied	1	MARGINAL
AX-2026-042064	TFC	TFC-2601-L7201	Medutest	2026-Q2	99.92	3.89	105.0	Supplier-supplied	0	PASS
AX-2026-042063	TFC	TFC-2601-L7201	Janoshik	2026-Q2	99.52	4.63	—	Supplier-supplied	0	PASS
AX-2026-042224	Homopeptide	HOMO-2511-V9695	PeptideMeter	2026-Q1	99.93	5.28	104.5	Supplier-supplied	0	PASS
AX-2026-042202	Homopeptide	HOMO-2509-K9821	Janoshik	2026-Q1	99.03	5.04	99.1	Supplier-supplied	1	MARGINAL
AX-2026-042200	Homopeptide	HOMO-2509-K9821	Janoshik	2026-Q1	99.12	4.65	95.4	Supplier-supplied	1	MARGINAL
AX-2026-042203	Homopeptide	HOMO-2509-K9821	Janoshik	2026-Q1	99.59	4.60	100.0	Supplier-supplied	2	FAIL

Other recent BCH records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043574	N-Acetyl Semax Amide	BCH-2602-E8253	Janoshik	2026-Q3	97.75	8.85	97.9	Supplier-supplied	1	FAIL
AX-2026-043503	BPC-157	BCH-2603-G6422	Janoshik	2026-Q3	98.46	4.32	—	Supplier-supplied	1	MARGINAL
AX-2026-043575	N-Acetyl Semax Amide	BCH-2602-E8253	Janoshik	2026-Q3	97.44	9.19	104.8	Supplier-supplied	1	FAIL
AX-2026-043539	CJC-1295 with DAC	BCH-2607-H7307	Janoshik	2026-Q3	98.12	5.78	100.6	Supplier-supplied	1	MARGINAL
AX-2026-043504	BPC-157	BCH-2603-G6422	Janoshik	2026-Q3	98.38	4.45	95.5	Supplier-supplied	1	MARGINAL
AX-2026-043502	BPC-157	BCH-2603-G6422	PeptideMeter	2026-Q3	97.72	4.86	—	Buyer-sourced	1	FAIL
AX-2026-043501	BPC-157	BCH-2603-G6422	PeptideMeter	2026-Q3	98.37	4.75	100.8	Supplier-supplied	1	MARGINAL
AX-2026-043573	N-Acetyl Semax Amide	BCH-2602-E8253	Janoshik	2026-Q3	97.47	8.59	—	Supplier-supplied	1	FAIL