AssayIndex

HJ-2508-P3416

Tirzepatide · 15 mg declared · Hubei Jianxiang Bioscience Co., Ltd. · manufactured 30 Aug 2025

CHARACTERISED
Lot code
HJ-2508-P3416
Supplier
HJ — Hubei Jianxiang Bioscience Co., Ltd.
Compound
Tirzepatide
Compound class
Incretin analogues and co-agonists
Declared label claim
15mg
Manufacture date
30 Aug 2025
Index quarter
2026-Q1
Independent assays
12
Laboratories involved
Janoshik, Medutest, PeptideMeter, Kestrel
Provenance mix
Supplier-supplied ×11 · 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 12
Median purity 98.55% n=12
Spread (max − min) 1.41pp n=12
Standard deviation 0.388pp n=12
95.696.497.197.998.799.5100.3This lot (HJ-2508-P3416)This lot (HJ-2508-P3416): Q1 98.31, median 98.55, Q3 98.78, n=12n=12All 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 12

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-2026-042304HJ-2508-P3416Janoshik2026-Q198.364.16Laboratory-retained3MARGINAL
AX-2026-042305HJ-2508-P3416Janoshik2026-Q198.184.2290.2Supplier-supplied3MARGINAL
AX-2026-042306HJ-2508-P3416Janoshik2026-Q197.793.6690.1Supplier-supplied3MARGINAL
AX-2026-042307HJ-2508-P3416Janoshik2026-Q198.504.1188.9Supplier-supplied4MARGINAL
AX-2026-042308HJ-2508-P3416Medutest2026-Q198.774.06Supplier-supplied3MARGINAL
AX-2026-042309HJ-2508-P3416PeptideMeter2026-Q198.834.5389.9Supplier-supplied4MARGINAL
AX-2026-042310HJ-2508-P3416Janoshik2026-Q198.804.50Supplier-supplied3MARGINAL
AX-2026-042311HJ-2508-P3416Kestrel2026-Q199.203.86105.7Supplier-supplied3MARGINAL
AX-2026-042312HJ-2508-P3416Medutest2026-Q198.044.86100.1Supplier-supplied3MARGINAL
AX-2026-042313HJ-2508-P3416Medutest2026-Q198.753.74102.0Supplier-supplied3MARGINAL
AX-2026-042314HJ-2508-P3416PeptideMeter2026-Q198.554.67100.5Supplier-supplied3MARGINAL
AX-2026-042315HJ-2508-P3416PeptideMeter2026-Q198.544.03107.0Supplier-supplied3MARGINAL
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
Janoshik598.36, 98.18, 97.79, 98.50, 98.8098.3630min+0.0098.36
Medutest398.77, 98.04, 98.7598.7525min+0.0898.67
PeptideMeter398.83, 98.55, 98.5498.5528min-0.0598.60
Kestrel199.2099.2015min+0.2498.96

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)99.098.36divergence +0.45 pp vs batch median
Total impurities (% area)not stated1.64
Largest single impurity (% area)not stated0.84
Water (%)3.14.16
Counter-ion (%)9.48.82
Peptide content (%w/w)96.6not 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
truncated (3-39)12 / 120.200.07–0.45
[D-Aib13]-diastereomer12 / 120.140.05–0.33
Met(O) sulfoxide (+16 Da)12 / 120.080.02–0.19
trifluoroacetyl adduct (+96 Da)12 / 120.110.02–0.49
des-Aib2 analogue10 / 120.040.01–0.07
des-Gly deletion (−57 Da)6 / 120.790.61–1.13
C20 diacid mono-amide6 / 120.930.31–1.25
Section 7

What this rollup does not establish