AssayIndex

SGN-2506-J8941

Tirzepatide · 20 mg declared · Sangon Biotech (Shanghai) Co., Ltd. · manufactured 15 Jun 2025

CHARACTERISEDSHARED BULK
Lot code
SGN-2506-J8941
Supplier
SGN — Sangon Biotech (Shanghai) Co., Ltd.
Compound
Tirzepatide
Compound class
Incretin analogues and co-agonists
Declared label claim
20mg
Manufacture date
15 Jun 2025
Index quarter
2025-Q3
Independent assays
8
Laboratories involved
Janoshik, Medutest, Nordanalyt, PeptideMeter
Provenance mix
Buyer-sourced ×1 · Supplier-supplied ×7
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 97.12% n=8
Spread (max − min) 1.55pp n=8
Standard deviation 0.513pp n=8
95.696.497.197.998.799.5100.3This lot (SGN-2506-J8941)This lot (SGN-2506-J8941): Q1 96.81, median 97.12, Q3 97.45, n=8n=8All TirzepatideAll Tirzepatide: Q1 97.85, median 98.44, Q3 99.08, n=576outlier 95.92n=576 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 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-2025-020729SGN-2506-J8941Janoshik2025-Q397.461.92Supplier-supplied3MARGINAL
AX-2025-020730SGN-2506-J8941Janoshik2025-Q397.162.15101.8Supplier-supplied3MARGINAL
AX-2025-020731SGN-2506-J8941Janoshik2025-Q397.452.1793.0Supplier-supplied3MARGINAL
AX-2025-020732SGN-2506-J8941Medutest2025-Q397.852.21Supplier-supplied3MARGINAL
AX-2025-020733SGN-2506-J8941Janoshik2025-Q396.512.52Supplier-supplied3FAIL
AX-2025-020734SGN-2506-J8941Medutest2025-Q396.302.22Buyer-sourced2FAIL
AX-2025-020735SGN-2506-J8941Nordanalyt2025-Q397.082.0599.2Supplier-supplied3MARGINAL
AX-2025-020736SGN-2506-J8941PeptideMeter2025-Q396.912.06101.1Supplier-supplied3FAIL
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
Janoshik497.46, 97.16, 97.45, 96.5197.3130min+0.0097.31
Medutest297.85, 96.3097.0725min+0.0896.99
Nordanalyt197.0897.0835min+0.0297.06
PeptideMeter196.9196.9128min-0.0596.96

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)97.7697.46divergence +0.64 pp vs batch median
Total impurities (% area)2.242.54
Largest single impurity (% area)1.381.21
Water (%)not stated1.92
Counter-ion (%)not stated5.67
Peptide content (%w/w)99.3not determined
Endotoxin (EU/mg)1.45not 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
C20 diacid mono-amide8 / 80.660.07–1.66
trifluoroacetyl adduct (+96 Da)8 / 80.430.08–0.99
Met(O) sulfoxide (+16 Da)8 / 80.120.04–0.21
[D-Aib13]-diastereomer8 / 80.760.12–2.31
des-Gly deletion (−57 Da)8 / 80.170.06–0.45
des-Aib2 analogue4 / 80.290.27–0.37
truncated (3-39)4 / 80.500.36–0.62
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-N7925GL Biochemparent bulk397.05
SGN-2506-J8941SGNthis lot897.12
Section 7

What this rollup does not establish