AssayIndex

SGN-2602-Y9898

Afamelanotide · 10 mg declared · Sangon Biotech (Shanghai) Co., Ltd. · manufactured 25 Feb 2026

PARTIALLY CHARACTERISED
Lot code
SGN-2602-Y9898
Supplier
SGN — Sangon Biotech (Shanghai) Co., Ltd.
Compound
Afamelanotide
Compound class
Melanocortin-receptor peptides
Declared label claim
10mg
Manufacture date
25 Feb 2026
Index quarter
2026-Q3
Independent assays
2
Laboratories involved
Janoshik, PeptideMeter
Provenance mix
Supplier-supplied ×2
Section 1

Reproducibility across independent tests

Every report below is an observation of the same physical material. What they disagree about is measurement; what they agree about is the lot. The size of the disagreement is compared against what the contributing laboratories' own repeatability figures predict.

Independent assays 2
Median purity 99.06% n=2
Spread (max − min) 0.27pp n=2
Standard deviation n<3 n=2
96.897.497.998.599.099.6100.2This lot (SGN-2602-Y9898)This lot (SGN-2602-Y9898): Q1 98.99, median 99.06, Q3 99.12, n=2n=2All AfamelanotideAll Afamelanotide: Q1 98.58, median 99.28, Q3 99.87, n=53n=53 Purity (% area)
Figure 1. This lot's independent purity results against the whole Afamelanotide record set in the index. The vertical line is the index acceptance specification for the melanocortin-receptor peptides class, 98.0 % area. A narrow box on the top row against a wide box on the bottom row is the ideal reading: it means the disagreement between lots is much larger than the disagreement within this one.
Section 2

Member reports 2

Every report the index holds on this lot. Each is a page carrying its own chromatogram, mass spectrum, mass balance, provenance and caveats.

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043214SGN-2602-Y9898Janoshik2026-Q399.193.41106.9Supplier-supplied1MARGINAL
AX-2026-043215SGN-2602-Y9898PeptideMeter2026-Q398.923.40Supplier-supplied1MARGINAL
Section 3

By laboratory

Where more than one laboratory assayed this lot, the difference between them is a paired observation of their relative bias — the same material, the same time window, different instruments. Those pairs are what the index's bias estimates are built from.

LaboratoryReportsPurity results (% area)MedianGradientPublished bias (pp)Bias-adjusted
Janoshik199.1999.1930min+0.0099.19
PeptideMeter198.9298.9228min-0.0598.97

This lot contributes 1 paired comparison to the inter-lab analysis.

Section 4

The supplier's certificate for this lot

One number the supplier wrote, beside the median of the numbers other people measured on the same physical material. That comparison is only available because the index groups by lot.

FigureSupplier COAThis reportIndex note
Purity (% area)99.099.19divergence -0.06 pp vs batch median
Total impurities (% area)1.000.81
Largest single impurity (% area)0.510.31
Water (%)not stated3.41
Counter-ion (%)not stated2.67
Peptide content (%w/w)not stated92.97
Endotoxin (EU/mg)not stated0.36
Method stated on certificateYEScolumn, gradient and wavelength given
Section 5

Impurity fingerprint

The named impurities reported across this lot's assays, with how consistently each was seen. A fingerprint is what allows two lot numbers held by different companies to be identified as one bulk.

Named impurityReported inMedian % areaRange
des-acetyl (−42 Da)2 / 20.350.31–0.40
Met sulfoxide (+16 Da)2 / 20.310.28–0.33
oxidised Trp (+16 Da)2 / 20.130.10–0.15
native α-MSH (−32 Da)2 / 20.160.07–0.25
Section 7

What this rollup does not establish