AssayIndex

SSA-2511-N7633

Tirzepatide · 5 mg declared · Shanghai Sigma-Audley New Material Technology Co., Ltd. · manufactured 04 Nov 2025

CHARACTERISEDSHARED BULK
Lot code
SSA-2511-N7633
Supplier
SSA — Shanghai Sigma-Audley New Material Technology Co., Ltd.
Compound
Tirzepatide
Compound class
Incretin analogues and co-agonists
Declared label claim
5mg
Manufacture date
04 Nov 2025
Index quarter
2026-Q2
Independent assays
13
Laboratories involved
Nordanalyt, Janoshik, PeptideMeter, VendorInvestigate, Medutest
Provenance mix
Buyer-sourced ×12 · Supplier-supplied ×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 13
Median purity 97.27% n=13
Spread (max − min) 0.98pp n=13
Standard deviation 0.278pp n=13
96.096.797.498.198.899.5100.2This lot (SSA-2511-N7633)This lot (SSA-2511-N7633): Q1 97.14, median 97.27, Q3 97.43, n=13outlier 97.90n=13All TirzepatideAll Tirzepatide: Q1 97.93, median 98.47, Q3 98.93, n=573outlier 96.33n=573 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 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-2026-043208SSA-2511-N7633Nordanalyt2026-Q297.725.52Buyer-sourced1MARGINAL
AX-2026-043209SSA-2511-N7633Janoshik2026-Q297.085.04Buyer-sourced1MARGINAL
AX-2026-043210SSA-2511-N7633PeptideMeter2026-Q297.285.67Buyer-sourced1MARGINAL
AX-2026-043211SSA-2511-N7633Janoshik2026-Q297.435.02Buyer-sourced2MARGINAL
AX-2026-043212SSA-2511-N7633VendorInvestigate2026-Q296.925.38Buyer-sourced1FAIL
AX-2026-043213SSA-2511-N7633PeptideMeter2026-Q297.355.57102.5Buyer-sourced1MARGINAL
AX-2026-043214SSA-2511-N7633VendorInvestigate2026-Q297.185.1298.1Buyer-sourced1MARGINAL
AX-2026-043215SSA-2511-N7633Janoshik2026-Q297.275.7499.9Buyer-sourced1MARGINAL
AX-2026-043216SSA-2511-N7633Medutest2026-Q297.905.5890.4Supplier-supplied1MARGINAL
AX-2026-043217SSA-2511-N7633Nordanalyt2026-Q297.106.1091.4Buyer-sourced1MARGINAL
AX-2026-043218SSA-2511-N7633VendorInvestigate2026-Q297.275.47100.9Buyer-sourced1MARGINAL
AX-2026-043219SSA-2511-N7633Medutest2026-Q297.145.11102.8Buyer-sourced2MARGINAL
AX-2026-043220SSA-2511-N7633PeptideMeter2026-Q297.635.29Buyer-sourced1MARGINAL
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
Nordanalyt297.72, 97.1097.4135min+0.0297.39
Janoshik397.08, 97.43, 97.2797.2730min+0.0097.27
PeptideMeter397.28, 97.35, 97.6397.3528min-0.0597.40
VendorInvestigate396.92, 97.18, 97.2797.1832min-0.1197.29
Medutest297.90, 97.1497.5225min+0.0897.44

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)97.5297.72divergence +0.25 pp vs batch median
Total impurities (% area)2.482.28
Largest single impurity (% area)1.281.09
Water (%)3.95.52
Counter-ion (%)2.59.24
Peptide content (%w/w)93.0not determined
Endotoxin (EU/mg)not statednot determined
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
C20 diacid mono-amide13 / 131.010.08–1.47
trifluoroacetyl adduct (+96 Da)13 / 130.590.10–0.87
Met(O) sulfoxide (+16 Da)13 / 130.130.05–0.19
[D-Aib13]-diastereomer13 / 130.150.10–1.82
des-Gly deletion (−57 Da)13 / 130.070.05–0.36
des-Aib2 analogue7 / 130.290.22–0.33
truncated (3-39)6 / 130.470.43–0.49
Section 6

Shared-bulk links

Rule AX-R09. Where impurity fingerprints and latent composition match across companies, the index treats the material as one bulk and counts it once in aggregates.

LotSold byRoleReportsMedian purity
GLBI-2510-N8332GL Biochemparent bulk397.24
SSA-2511-N7633SSAthis lot1397.27
Section 7

What this rollup does not establish