AssayIndex

MKM-2411-E3058

Survodutide · 5 mg declared · Xi'an Mokemei Biotechnology Co., Ltd. · manufactured 28 Nov 2024

CHARACTERISED
Lot code
MKM-2411-E3058
Supplier
MKM — Xi'an Mokemei Biotechnology Co., Ltd.
Compound
Survodutide
Compound class
Incretin analogues and co-agonists
Declared label claim
5mg
Manufacture date
28 Nov 2024
Index quarter
2025-Q2
Independent assays
8
Laboratories involved
Janoshik, PeptideMeter, Nordanalyt, Medutest, Kestrel
Provenance mix
Supplier-supplied ×8
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 8
Median purity 97.90% n=8
Spread (max − min) 1.18pp n=8
Standard deviation 0.336pp n=8
97.297.798.198.699.199.6100.1This lot (MKM-2411-E3058)This lot (MKM-2411-E3058): Q1 97.75, median 97.90, Q3 97.95, n=8outlier 97.44outlier 98.62n=8All SurvodutideAll Survodutide: Q1 98.09, median 98.69, Q3 99.16, n=68n=68 Purity (% area)
Figure 1. This lot's independent purity results against the whole Survodutide record set in the index. The vertical line is the index acceptance specification for the incretin analogues and co-agonists class, 96.5 % 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 8

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-2025-020316MKM-2411-E3058Janoshik2025-Q297.724.71102.8Supplier-supplied1MARGINAL
AX-2025-020317MKM-2411-E3058PeptideMeter2025-Q297.883.91Supplier-supplied1MARGINAL
AX-2025-020318MKM-2411-E3058Nordanalyt2025-Q297.764.43Supplier-supplied1MARGINAL
AX-2025-020319MKM-2411-E3058Medutest2025-Q297.925.25Supplier-supplied1MARGINAL
AX-2025-020320MKM-2411-E3058Janoshik2025-Q297.994.5695.4Supplier-supplied1MARGINAL
AX-2025-020321MKM-2411-E3058Kestrel2025-Q297.444.17101.6Supplier-supplied1MARGINAL
AX-2025-020322MKM-2411-E3058Janoshik2025-Q298.624.8791.4Supplier-supplied1MARGINAL
AX-2025-020323MKM-2411-E3058PeptideMeter2025-Q297.944.0889.6Supplier-supplied2MARGINAL
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
Janoshik397.72, 97.99, 98.6297.9930min+0.0097.99
PeptideMeter297.88, 97.9497.9128min-0.0597.96
Nordanalyt197.7697.7635min+0.0297.74
Medutest197.9297.9225min+0.0897.84
Kestrel197.4497.4415min+0.2497.20

This lot contributes 10 paired comparisons 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)98.3997.72divergence +0.49 pp vs batch median
Total impurities (% area)1.612.28
Largest single impurity (% area)0.760.97
Water (%)3.44.71
Counter-ion (%)not stated5.82
Peptide content (%w/w)not stated88.72
Endotoxin (EU/mg)not stated0.98
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
survodutide dimer8 / 80.460.28–0.97
truncated (2-39)8 / 80.240.10–0.59
[D-Ser2]-diastereomer8 / 80.920.25–1.76
aspartimide (−18 Da)8 / 80.080.03–0.20
C18 diacid mono-ester8 / 80.040.03–0.05
des-γGlu linker (−129 Da)8 / 80.130.03–0.25
Section 7

What this rollup does not establish