AssayIndex

GGPE-2502-J8885

Tirzepatide · 15 mg declared · Nantong Guangyuan Chemical Co., Ltd. · manufactured 22 Feb 2025

CHARACTERISED
Lot code
GGPE-2502-J8885
Supplier
GGPeps — Nantong Guangyuan Chemical Co., Ltd.
Compound
Tirzepatide
Compound class
Incretin analogues and co-agonists
Declared label claim
15mg
Manufacture date
22 Feb 2025
Index quarter
2025-Q3
Independent assays
11
Laboratories involved
Janoshik, VendorInvestigate, Kestrel
Provenance mix
Buyer-sourced ×2 · Supplier-supplied ×8 · 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 97.86% n=11
Spread (max − min) 1.76pp n=11
Standard deviation 0.530pp n=11
95.696.497.197.998.799.5100.3This lot (GGPE-2502-J8885)This lot (GGPE-2502-J8885): Q1 97.73, median 97.86, Q3 98.33, n=11outlier 99.28n=11All 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 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-2025-020109GGPE-2502-J8885Janoshik2025-Q397.546.26103.2Supplier-supplied2MARGINAL
AX-2025-020110GGPE-2502-J8885Janoshik2025-Q398.195.7993.6Supplier-supplied2MARGINAL
AX-2025-020111GGPE-2502-J8885Janoshik2025-Q398.295.48106.3Supplier-supplied2MARGINAL
AX-2025-020112GGPE-2502-J8885Janoshik2025-Q397.866.24Supplier-supplied2MARGINAL
AX-2025-020113GGPE-2502-J8885Janoshik2025-Q397.526.10Laboratory-retained2MARGINAL
AX-2025-020114GGPE-2502-J8885VendorInvestigate2025-Q397.805.92Buyer-sourced2MARGINAL
AX-2025-020115GGPE-2502-J8885VendorInvestigate2025-Q397.675.95Buyer-sourced2MARGINAL
AX-2025-020116GGPE-2502-J8885Janoshik2025-Q398.376.11100.4Supplier-supplied3FAIL
AX-2025-020117GGPE-2502-J8885Janoshik2025-Q398.585.63Supplier-supplied2MARGINAL
AX-2025-020118GGPE-2502-J8885Kestrel2025-Q399.285.6595.9Supplier-supplied2MARGINAL
AX-2025-020119GGPE-2502-J8885Janoshik2025-Q397.805.5095.7Supplier-supplied2MARGINAL
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
Janoshik897.54, 98.19, 98.29, 97.86, 97.52, 98.37, 98.58, 97.8098.0330min+0.0098.03
VendorInvestigate297.80, 97.6797.7332min-0.1197.84
Kestrel199.2899.2815min+0.2499.04

This lot contributes 3 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)98.5397.54divergence +0.67 pp vs batch median
Total impurities (% area)not stated2.46
Largest single impurity (% area)not stated1.64
Water (%)5.36.26
Counter-ion (%)not stated9.45
Peptide content (%w/w)not stated83.80
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
[D-Aib13]-diastereomer11 / 111.160.40–1.65
des-Aib2 analogue11 / 110.300.08–0.33
C20 diacid mono-amide11 / 110.030.01–0.06
tirzepatide dimer10 / 110.030.01–0.04
truncated (3-39)6 / 110.210.13–0.23
des-Gly deletion (−57 Da)6 / 110.150.10–0.17
trifluoroacetyl adduct (+96 Da)5 / 110.450.18–0.55
Met(O) sulfoxide (+16 Da)5 / 110.080.04–0.10
Section 7

What this rollup does not establish