AssayIndex

TFC-2409-Y6260

Survodutide · 15 mg declared · Tianjin Finder Chemical Co., Ltd. · manufactured 18 Sep 2024

CHARACTERISED
Lot code
TFC-2409-Y6260
Supplier
TFC — Tianjin Finder Chemical Co., Ltd.
Compound
Survodutide
Compound class
Incretin analogues and co-agonists
Declared label claim
15mg
Manufacture date
18 Sep 2024
Index quarter
2025-Q1
Independent assays
13
Laboratories involved
PeptideMeter, VendorInvestigate, Janoshik, Medutest, Kestrel
Provenance mix
Buyer-sourced ×3 · Supplier-supplied ×10
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 13
Median purity 98.97% n=13
Spread (max − min) 1.48pp n=13
Standard deviation 0.412pp n=13
97.297.798.198.699.199.6100.1This lot (TFC-2409-Y6260)This lot (TFC-2409-Y6260): Q1 98.57, median 98.97, Q3 99.15, n=13n=13All 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 13

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-2025-019268TFC-2409-Y6260PeptideMeter2025-Q198.976.31Supplier-supplied1MARGINAL
AX-2025-019269TFC-2409-Y6260VendorInvestigate2025-Q198.126.8297.9Buyer-sourced1MARGINAL
AX-2025-019270TFC-2409-Y6260VendorInvestigate2025-Q198.576.5892.0Buyer-sourced2MARGINAL
AX-2025-019271TFC-2409-Y6260PeptideMeter2025-Q199.606.27104.3Supplier-supplied2FAIL
AX-2025-019272TFC-2409-Y6260PeptideMeter2025-Q199.115.9591.9Supplier-supplied1MARGINAL
AX-2025-019273TFC-2409-Y6260Janoshik2025-Q198.666.3299.2Supplier-supplied1MARGINAL
AX-2025-019274TFC-2409-Y6260Janoshik2025-Q199.056.36Supplier-supplied1MARGINAL
AX-2025-019275TFC-2409-Y6260Janoshik2025-Q199.276.5792.1Supplier-supplied2FAIL
AX-2025-019276TFC-2409-Y6260VendorInvestigate2025-Q198.415.8990.7Buyer-sourced1MARGINAL
AX-2025-019277TFC-2409-Y6260Medutest2025-Q198.866.17103.6Supplier-supplied1MARGINAL
AX-2025-019278TFC-2409-Y6260Janoshik2025-Q199.156.30Supplier-supplied1MARGINAL
AX-2025-019279TFC-2409-Y6260Janoshik2025-Q199.176.84Supplier-supplied1MARGINAL
AX-2025-019280TFC-2409-Y6260Kestrel2025-Q198.466.84Supplier-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
PeptideMeter398.97, 99.60, 99.1199.1128min-0.0599.16
VendorInvestigate398.12, 98.57, 98.4198.4132min-0.1198.52
Janoshik598.66, 99.05, 99.27, 99.15, 99.1799.1530min+0.0099.15
Medutest198.8698.8625min+0.0898.78
Kestrel198.4698.4615min+0.2498.22

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)99.8298.97divergence +0.85 pp vs batch median
Total impurities (% area)0.181.03
Largest single impurity (% area)0.100.70
Water (%)5.06.31
Counter-ion (%)not stated9.68
Peptide content (%w/w)not statednot determined
Endotoxin (EU/mg)0.21not determined
Method stated on certificateNOno method section — the result cannot be reconciled against any other
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
truncated (2-39)13 / 130.600.11–0.79
[D-Ser2]-diastereomer13 / 130.470.14–0.81
C18 diacid mono-ester13 / 130.070.03–0.17
des-γGlu linker (−129 Da)12 / 130.020.02–0.06
aspartimide (−18 Da)9 / 130.090.04–0.21
survodutide dimer9 / 130.020.02–0.10
Section 7

What this rollup does not establish