AssayIndex

BCH-2404-N7401

Tirzepatide · 15 mg declared · Bachem Holding (Suzhou) Co., Ltd. · manufactured 30 Apr 2024

CHARACTERISED
Lot code
BCH-2404-N7401
Supplier
BCH — Bachem Holding (Suzhou) Co., Ltd.
Compound
Tirzepatide
Compound class
Incretin analogues and co-agonists
Declared label claim
15mg
Manufacture date
30 Apr 2024
Index quarter
2024-Q3
Independent assays
16
Laboratories involved
Janoshik, Nordanalyt, Medutest, Kestrel, PeptideMeter
Provenance mix
Buyer-sourced ×10 · Supplier-supplied ×4 · 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 16
Median purity 97.95% n=16
Spread (max − min) 1.64pp n=16
Standard deviation 0.391pp n=16
96.096.797.498.198.899.5100.2This lot (BCH-2404-N7401)This lot (BCH-2404-N7401): Q1 97.76, median 97.95, Q3 98.06, n=16outlier 99.00n=16All 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 16

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-2024-005508BCH-2404-N7401Janoshik2024-Q398.033.2895.9Laboratory-retained0PASS
AX-2024-005509BCH-2404-N7401Janoshik2024-Q397.992.92Buyer-sourced0PASS
AX-2024-005510BCH-2404-N7401Janoshik2024-Q398.073.8789.9Buyer-sourced1MARGINAL
AX-2024-005511BCH-2404-N7401Nordanalyt2024-Q397.363.24Buyer-sourced0PASS
AX-2024-005512BCH-2404-N7401Janoshik2024-Q397.942.89106.7Buyer-sourced0PASS
AX-2024-005513BCH-2404-N7401Nordanalyt2024-Q397.503.66Buyer-sourced0PASS
AX-2024-005514BCH-2404-N7401Medutest2024-Q398.353.07Buyer-sourced0PASS
AX-2024-005515BCH-2404-N7401Kestrel2024-Q397.963.34Buyer-sourced1FAIL
AX-2024-005516BCH-2404-N7401Nordanalyt2024-Q397.933.86107.3Supplier-supplied0PASS
AX-2024-005517BCH-2404-N7401Kestrel2024-Q397.933.08105.9Laboratory-retained1FAIL
AX-2024-005518BCH-2404-N7401Janoshik2024-Q397.763.6897.4Supplier-supplied0PASS
AX-2024-005519BCH-2404-N7401Kestrel2024-Q399.003.5098.1Supplier-supplied0PASS
AX-2024-005520BCH-2404-N7401Janoshik2024-Q397.763.50106.9Buyer-sourced0PASS
AX-2024-005521BCH-2404-N7401PeptideMeter2024-Q398.283.1289.7Supplier-supplied1MARGINAL
AX-2024-005522BCH-2404-N7401Janoshik2024-Q398.063.42Buyer-sourced0PASS
AX-2024-005523BCH-2404-N7401Medutest2024-Q397.443.6497.8Buyer-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
Janoshik798.03, 97.99, 98.07, 97.94, 97.76, 97.76, 98.0697.9930min+0.0097.99
Nordanalyt397.36, 97.50, 97.9397.5035min+0.0297.48
Medutest298.35, 97.4497.8925min+0.0897.81
Kestrel397.96, 97.93, 99.0097.9615min+0.2497.72
PeptideMeter198.2898.2828min-0.0598.33

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)98.0198.03divergence +0.06 pp vs batch median
Total impurities (% area)not stated1.97
Largest single impurity (% area)not stated1.16
Water (%)1.93.28
Counter-ion (%)not stated7.49
Peptide content (%w/w)not stated88.64
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
Met(O) sulfoxide (+16 Da)16 / 160.530.02–1.31
[D-Aib13]-diastereomer16 / 160.180.03–0.41
des-Aib2 analogue16 / 160.110.08–0.14
trifluoroacetyl adduct (+96 Da)15 / 160.020.01–0.03
truncated (3-39)8 / 160.320.26–0.36
tirzepatide dimer8 / 160.030.02–0.03
C20 diacid mono-amide8 / 161.220.57–1.57
des-Gly deletion (−57 Da)8 / 160.580.26–0.75
Section 7

What this rollup does not establish