AssayIndex

TFC-2312-P9824

Tirzepatide · 30 mg declared · Tianjin Finder Chemical Co., Ltd. · manufactured 12 Dec 2023

CHARACTERISED
Lot code
TFC-2312-P9824
Supplier
TFC — Tianjin Finder Chemical Co., Ltd.
Compound
Tirzepatide
Compound class
Incretin analogues and co-agonists
Declared label claim
30mg
Manufacture date
12 Dec 2023
Index quarter
2024-Q2
Independent assays
11
Laboratories involved
Kestrel, Medutest, Janoshik, VendorInvestigate, Nordanalyt, PeptideMeter
Provenance mix
Buyer-sourced ×10 · Laboratory-retained ×1
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 11
Median purity 98.45% n=11
Spread (max − min) 1.47pp n=11
Standard deviation 0.368pp n=11
95.796.597.298.098.799.5100.2This lot (TFC-2312-P9824)This lot (TFC-2312-P9824): Q1 98.32, median 98.45, Q3 98.62, n=11outlier 97.88outlier 99.35n=11All TirzepatideAll Tirzepatide: Q1 97.99, median 98.54, Q3 98.98, n=706outlier 96.03outlier 96.21outlier 96.46outlier 96.47n=706 Purity (% area)
Figure 1. This lot's independent purity results against the whole Tirzepatide record set in the index. The vertical line is the index acceptance specification for the incretin analogues and co-agonists class, 97.0 % 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 11

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-2024-004798TFC-2312-P9824Kestrel2024-Q299.353.13Buyer-sourced0PASS
AX-2024-004799TFC-2312-P9824Medutest2024-Q298.773.52103.4Buyer-sourced0PASS
AX-2024-004800TFC-2312-P9824Janoshik2024-Q298.272.20101.3Buyer-sourced0PASS
AX-2024-004801TFC-2312-P9824VendorInvestigate2024-Q298.233.5696.6Buyer-sourced0PASS
AX-2024-004802TFC-2312-P9824Nordanalyt2024-Q298.422.8498.2Buyer-sourced0PASS
AX-2024-004803TFC-2312-P9824Janoshik2024-Q298.613.84Buyer-sourced0PASS
AX-2024-004804TFC-2312-P9824Medutest2024-Q298.383.2889.2Buyer-sourced1MARGINAL
AX-2024-004805TFC-2312-P9824PeptideMeter2024-Q298.633.14104.3Buyer-sourced0PASS
AX-2024-004806TFC-2312-P9824Janoshik2024-Q298.452.9794.7Buyer-sourced0PASS
AX-2024-004807TFC-2312-P9824PeptideMeter2024-Q297.883.3389.1Buyer-sourced1MARGINAL
AX-2024-004808TFC-2312-P9824Janoshik2024-Q298.503.3994.2Laboratory-retained0PASS
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
Kestrel199.3599.3515min+0.2499.11
Medutest298.77, 98.3898.5725min+0.0898.49
Janoshik498.27, 98.61, 98.45, 98.5098.4730min+0.0098.47
VendorInvestigate198.2398.2332min-0.1198.34
Nordanalyt198.4298.4235min+0.0298.40
PeptideMeter298.63, 97.8898.2528min-0.0598.30

This lot contributes 15 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)98.0599.35divergence -0.40 pp vs batch median
Total impurities (% area)1.950.65
Largest single impurity (% area)0.950.35
Water (%)1.83.13
Counter-ion (%)not stated9.45
Peptide content (%w/w)93.4not determined
Endotoxin (EU/mg)not stated1.52
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 (3-39)11 / 110.610.35–0.80
[D-Aib13]-diastereomer11 / 110.090.02–0.26
Met(O) sulfoxide (+16 Da)11 / 110.050.04–1.02
trifluoroacetyl adduct (+96 Da)11 / 110.040.02–0.08
tirzepatide dimer10 / 110.100.02–0.31
des-Aib2 analogue6 / 110.510.15–0.56
C20 diacid mono-amide5 / 110.040.03–0.06
Section 7

What this rollup does not establish