AssayIndex

HJ-2501-P2892

Tirzepatide · 30 mg declared · Hubei Jianxiang Bioscience Co., Ltd. · manufactured 21 Jan 2025

CHARACTERISED
Lot code
HJ-2501-P2892
Supplier
HJ — Hubei Jianxiang Bioscience Co., Ltd.
Compound
Tirzepatide
Compound class
Incretin analogues and co-agonists
Declared label claim
30mg
Manufacture date
21 Jan 2025
Index quarter
2025-Q1
Independent assays
12
Laboratories involved
Kestrel, Janoshik, Medutest, Nordanalyt, PeptideMeter, VendorInvestigate
Provenance mix
Buyer-sourced ×3 · Supplier-supplied ×9
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 98.16% n=12
Spread (max − min) 1.88pp n=12
Standard deviation 0.558pp n=12
95.696.497.197.998.799.5100.3This lot (HJ-2501-P2892)This lot (HJ-2501-P2892): Q1 97.92, median 98.16, Q3 98.51, n=12outlier 99.41n=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-2025-019701HJ-2501-P2892Kestrel2025-Q199.412.13Supplier-supplied3FAIL
AX-2025-019702HJ-2501-P2892Janoshik2025-Q198.163.0094.2Supplier-supplied2MARGINAL
AX-2025-019703HJ-2501-P2892Janoshik2025-Q198.302.6398.6Supplier-supplied2MARGINAL
AX-2025-019704HJ-2501-P2892Medutest2025-Q197.532.16Supplier-supplied2MARGINAL
AX-2025-019705HJ-2501-P2892Nordanalyt2025-Q198.142.52Supplier-supplied2MARGINAL
AX-2025-019706HJ-2501-P2892Janoshik2025-Q197.852.52Buyer-sourced2MARGINAL
AX-2025-019707HJ-2501-P2892Janoshik2025-Q198.442.2589.7Supplier-supplied3MARGINAL
AX-2025-019708HJ-2501-P2892PeptideMeter2025-Q197.692.24Supplier-supplied2MARGINAL
AX-2025-019709HJ-2501-P2892Janoshik2025-Q198.722.26102.4Supplier-supplied2MARGINAL
AX-2025-019710HJ-2501-P2892VendorInvestigate2025-Q198.152.78Buyer-sourced2MARGINAL
AX-2025-019711HJ-2501-P2892VendorInvestigate2025-Q197.952.4990.5Buyer-sourced2MARGINAL
AX-2025-019712HJ-2501-P2892Janoshik2025-Q199.102.41Supplier-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
Kestrel199.4199.4115min+0.2499.17
Janoshik698.16, 98.30, 97.85, 98.44, 98.72, 99.1098.3730min+0.0098.37
Medutest197.5397.5325min+0.0897.45
Nordanalyt198.1498.1435min+0.0298.12
PeptideMeter197.6997.6928min-0.0597.74
VendorInvestigate298.15, 97.9598.0532min-0.1198.16

This lot contributes 15 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)99.0499.41divergence +0.88 pp vs batch median
Total impurities (% area)0.960.59
Largest single impurity (% area)not stated0.36
Water (%)0.42.13
Counter-ion (%)3.26.42
Peptide content (%w/w)96.5not determined
Endotoxin (EU/mg)0.27not 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
[D-Aib13]-diastereomer12 / 120.210.05–1.44
des-Aib2 analogue12 / 120.300.15–0.72
truncated (3-39)12 / 120.110.06–0.20
des-Gly deletion (−57 Da)11 / 120.360.01–1.06
tirzepatide dimer6 / 120.050.02–0.06
C20 diacid mono-amide6 / 120.340.15–0.42
Met(O) sulfoxide (+16 Da)5 / 120.080.06–0.08
trifluoroacetyl adduct (+96 Da)5 / 120.010.01–0.01
Section 7

What this rollup does not establish