AssayIndex

HYB-2512-W3093

Tirzepatide · 10 mg declared · Shenzhen Hybio Pharmaceutical Co., Ltd. · manufactured 12 Dec 2025

CHARACTERISED
Lot code
HYB-2512-W3093
Supplier
HYB — Shenzhen Hybio Pharmaceutical Co., Ltd.
Compound
Tirzepatide
Compound class
Incretin analogues and co-agonists
Declared label claim
10mg
Manufacture date
12 Dec 2025
Index quarter
2026-Q2
Independent assays
10
Laboratories involved
Janoshik, Kestrel, PeptideMeter, Medutest
Provenance mix
Buyer-sourced ×8 · Laboratory-retained ×2
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 10
Median purity 98.96% n=10
Spread (max − min) 0.86pp n=10
Standard deviation 0.262pp n=10
96.096.797.498.198.899.5100.2This lot (HYB-2512-W3093)This lot (HYB-2512-W3093): Q1 98.81, median 98.95, Q3 99.08, n=10outlier 99.60n=10All 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 10

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-2026-041826HYB-2512-W3093Janoshik2026-Q299.216.04101.7Buyer-sourced1FAIL
AX-2026-041827HYB-2512-W3093Janoshik2026-Q298.885.90107.1Buyer-sourced0PASS
AX-2026-041828HYB-2512-W3093Janoshik2026-Q299.046.40105.5Buyer-sourced0PASS
AX-2026-041829HYB-2512-W3093Kestrel2026-Q299.606.0696.0Laboratory-retained0PASS
AX-2026-041830HYB-2512-W3093PeptideMeter2026-Q298.846.16Buyer-sourced0PASS
AX-2026-041831HYB-2512-W3093Medutest2026-Q298.776.4194.5Laboratory-retained0PASS
AX-2026-041832HYB-2512-W3093Janoshik2026-Q298.806.0995.4Buyer-sourced0PASS
AX-2026-041833HYB-2512-W3093Janoshik2026-Q299.036.5699.5Buyer-sourced0PASS
AX-2026-041834HYB-2512-W3093Janoshik2026-Q299.106.54106.5Buyer-sourced0PASS
AX-2026-041835HYB-2512-W3093Janoshik2026-Q298.746.15Buyer-sourced1FAIL
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
Janoshik799.21, 98.88, 99.04, 98.80, 99.03, 99.10, 98.7499.0330min+0.0099.03
Kestrel199.6099.6015min+0.2499.36
PeptideMeter198.8498.8428min-0.0598.89
Medutest198.7798.7725min+0.0898.69

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)98.7599.21divergence -0.21 pp vs batch median
Total impurities (% area)1.250.79
Largest single impurity (% area)0.760.52
Water (%)4.36.04
Counter-ion (%)2.98.13
Peptide content (%w/w)92.284.90
Endotoxin (EU/mg)not stated5.06
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-amide10 / 100.080.03–0.18
truncated (3-39)10 / 100.130.02–0.79
Met(O) sulfoxide (+16 Da)9 / 100.040.02–0.07
tirzepatide dimer7 / 100.140.03–0.40
des-Gly deletion (−57 Da)6 / 100.160.03–0.38
[D-Aib13]-diastereomer5 / 100.590.49–0.76
des-Aib2 analogue5 / 100.100.03–0.16
Section 7

What this rollup does not establish