AssayIndex

HYB-2408-R4018

Tirzepatide · 15 mg declared · Shenzhen Hybio Pharmaceutical Co., Ltd. · manufactured 06 Aug 2024

CHARACTERISED
Lot code
HYB-2408-R4018
Supplier
HYB — Shenzhen Hybio Pharmaceutical Co., Ltd.
Compound
Tirzepatide
Compound class
Incretin analogues and co-agonists
Declared label claim
15mg
Manufacture date
06 Aug 2024
Index quarter
2025-Q1
Independent assays
11
Laboratories involved
VendorInvestigate, Janoshik, Kestrel, PeptideMeter, Medutest
Provenance mix
Buyer-sourced ×10 · 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 98.30% n=11
Spread (max − min) 0.83pp n=11
Standard deviation 0.251pp n=11
95.796.597.298.098.799.5100.2This lot (HYB-2408-R4018)This lot (HYB-2408-R4018): Q1 98.16, median 98.30, Q3 98.50, n=11n=11All TirzepatideAll Tirzepatide: Q1 97.99, median 98.54, Q3 98.98, n=706outlier 96.03outlier 96.21outlier 96.46outlier 96.47n=706 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-2025-019109HYB-2408-R4018VendorInvestigate2025-Q198.554.9689.9Buyer-sourced1MARGINAL
AX-2025-019110HYB-2408-R4018Janoshik2025-Q198.305.55Buyer-sourced0PASS
AX-2025-019111HYB-2408-R4018Kestrel2025-Q198.915.82Buyer-sourced0PASS
AX-2025-019112HYB-2408-R4018Janoshik2025-Q198.275.75103.7Laboratory-retained0PASS
AX-2025-019113HYB-2408-R4018Janoshik2025-Q198.465.6690.0Buyer-sourced0PASS
AX-2025-019114HYB-2408-R4018Janoshik2025-Q198.085.4588.6Buyer-sourced1MARGINAL
AX-2025-019115HYB-2408-R4018Janoshik2025-Q198.195.4290.6Buyer-sourced0PASS
AX-2025-019116HYB-2408-R4018PeptideMeter2025-Q198.135.3089.7Buyer-sourced1MARGINAL
AX-2025-019117HYB-2408-R4018Janoshik2025-Q198.545.6393.5Buyer-sourced0PASS
AX-2025-019118HYB-2408-R4018Medutest2025-Q198.084.9398.4Buyer-sourced0PASS
AX-2025-019119HYB-2408-R4018PeptideMeter2025-Q198.345.48Buyer-sourced0PASS
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
VendorInvestigate198.5598.5532min-0.1198.66
Janoshik698.30, 98.27, 98.46, 98.08, 98.19, 98.5498.2830min+0.0098.28
Kestrel198.9198.9115min+0.2498.67
PeptideMeter298.13, 98.3498.2328min-0.0598.28
Medutest198.0898.0825min+0.0898.00

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)98.8498.55divergence +0.54 pp vs batch median
Total impurities (% area)1.161.45
Largest single impurity (% area)0.670.56
Water (%)3.14.96
Counter-ion (%)4.39.21
Peptide content (%w/w)92.085.56
Endotoxin (EU/mg)not stated0.38
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 / 110.210.11–0.68
trifluoroacetyl adduct (+96 Da)11 / 110.060.05–0.07
truncated (3-39)11 / 110.030.03–1.34
tirzepatide dimer10 / 110.160.03–0.33
C20 diacid mono-amide6 / 110.600.56–0.70
Met(O) sulfoxide (+16 Da)6 / 110.240.17–0.29
des-Aib2 analogue5 / 110.040.03–0.04
des-Gly deletion (−57 Da)5 / 110.030.03–0.03
Section 7

What this rollup does not establish