AssayIndex

SSA-2508-P6978

Tirzepatide · 60 mg declared · Shanghai Sigma-Audley New Material Technology Co., Ltd. · manufactured 25 Aug 2025

CHARACTERISED
Lot code
SSA-2508-P6978
Supplier
SSA — Shanghai Sigma-Audley New Material Technology Co., Ltd.
Compound
Tirzepatide
Compound class
Incretin analogues and co-agonists
Declared label claim
60mg
Manufacture date
25 Aug 2025
Index quarter
2026-Q1
Independent assays
4
Laboratories involved
VendorInvestigate, Nordanalyt, PeptideMeter, Janoshik
Provenance mix
Buyer-sourced ×4
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 4
Median purity 97.53% n=4
Spread (max − min) 0.18pp n=4
Standard deviation 0.083pp n=4
95.796.597.298.098.799.5100.2This lot (SSA-2508-P6978)This lot (SSA-2508-P6978): Q1 97.52, median 97.53, Q3 97.57, n=4outlier 97.68n=4All 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 4

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-2026-043261SSA-2508-P6978VendorInvestigate2026-Q197.535.36101.8Buyer-sourced0PASS
AX-2026-043262SSA-2508-P6978Nordanalyt2026-Q197.685.46—Buyer-sourced0PASS
AX-2026-043263SSA-2508-P6978PeptideMeter2026-Q197.525.50—Buyer-sourced0PASS
AX-2026-043264SSA-2508-P6978Janoshik2026-Q197.505.58101.6Buyer-sourced0PASS
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
VendorInvestigate197.5397.5332min-0.1197.64
Nordanalyt197.6897.6835min+0.0297.66
PeptideMeter197.5297.5228min-0.0597.57
Janoshik197.5097.5030min+0.0097.50

This lot contributes 6 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)98.2097.53divergence +0.67 pp vs batch median
Total impurities (% area)1.802.47
Largest single impurity (% area)1.040.96
Water (%)not stated5.36
Counter-ion (%)not stated9.64
Peptide content (%w/w)not stated84.15
Endotoxin (EU/mg)not statednot determined
Method stated on certificateYES—column, 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-Aib2 analogue4 / 40.660.33–0.97
[D-Aib13]-diastereomer4 / 41.060.88–1.34
truncated (3-39)4 / 40.260.11–0.41
trifluoroacetyl adduct (+96 Da)4 / 40.070.04–0.08
C20 diacid mono-amide2 / 40.110.11–0.11
tirzepatide dimer2 / 40.040.03–0.04
des-Gly deletion (−57 Da)2 / 40.570.55–0.59
Met(O) sulfoxide (+16 Da)2 / 40.050.05–0.05
Section 7

What this rollup does not establish