AssayIndex

BCH-2407-F6722

Tirzepatide · 60 mg declared · Bachem Holding (Suzhou) Co., Ltd. · manufactured 14 Jul 2024

CHARACTERISED
Lot code
BCH-2407-F6722
Supplier
BCH — Bachem Holding (Suzhou) Co., Ltd.
Compound
Tirzepatide
Compound class
Incretin analogues and co-agonists
Declared label claim
60mg
Manufacture date
14 Jul 2024
Index quarter
2024-Q4
Independent assays
10
Laboratories involved
Medutest, Kestrel, Janoshik, PeptideMeter, VendorInvestigate
Provenance mix
Buyer-sourced ×4 · 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 10
Median purity 97.04% n=10
Spread (max − min) 1.43pp n=10
Standard deviation 0.443pp n=10
95.696.497.197.998.799.5100.3This lot (BCH-2407-F6722)This lot (BCH-2407-F6722): Q1 96.86, median 97.03, Q3 97.40, n=10n=10All 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 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-2024-005476BCH-2407-F6722Medutest2024-Q497.515.19103.1Supplier-supplied2MARGINAL
AX-2024-005477BCH-2407-F6722Kestrel2024-Q498.084.94102.7Supplier-supplied2MARGINAL
AX-2024-005478BCH-2407-F6722Janoshik2024-Q496.845.12Laboratory-retained2FAIL
AX-2024-005479BCH-2407-F6722Janoshik2024-Q497.145.14104.9Buyer-sourced2MARGINAL
AX-2024-005480BCH-2407-F6722PeptideMeter2024-Q497.314.9790.0Supplier-supplied2MARGINAL
AX-2024-005481BCH-2407-F6722Janoshik2024-Q496.655.44103.9Buyer-sourced2FAIL
AX-2024-005482BCH-2407-F6722VendorInvestigate2024-Q496.914.69Laboratory-retained2FAIL
AX-2024-005483BCH-2407-F6722Janoshik2024-Q497.435.06Supplier-supplied2MARGINAL
AX-2024-005484BCH-2407-F6722PeptideMeter2024-Q496.695.2389.8Buyer-sourced3FAIL
AX-2024-005485BCH-2407-F6722Janoshik2024-Q496.935.0291.3Buyer-sourced2FAIL
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
Medutest197.5197.5125min+0.0897.43
Kestrel198.0898.0815min+0.2497.84
Janoshik596.84, 97.14, 96.65, 97.43, 96.9396.9330min+0.0096.93
PeptideMeter297.31, 96.6997.0028min-0.0597.05
VendorInvestigate196.9196.9132min-0.1197.02

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)97.5297.51divergence +0.48 pp vs batch median
Total impurities (% area)2.482.49
Largest single impurity (% area)1.081.20
Water (%)not stated5.19
Counter-ion (%)not stated6.86
Peptide content (%w/w)not stated87.23
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
C20 diacid mono-amide10 / 101.330.86–1.60
[D-Aib13]-diastereomer10 / 100.690.33–1.05
des-Aib2 analogue10 / 100.200.05–0.38
trifluoroacetyl adduct (+96 Da)10 / 100.100.07–0.11
des-Gly deletion (−57 Da)5 / 100.110.09–0.12
Met(O) sulfoxide (+16 Da)5 / 100.050.04–0.06
truncated (3-39)5 / 100.700.47–0.83
tirzepatide dimer5 / 100.220.14–0.25
Section 7

What this rollup does not establish