AssayIndex

BCH-2505-Y7571

Semaglutide · 10 mg declared · Bachem Holding (Suzhou) Co., Ltd. · manufactured 25 May 2025

CHARACTERISED
Lot code
BCH-2505-Y7571
Supplier
BCH — Bachem Holding (Suzhou) Co., Ltd.
Compound
Semaglutide
Compound class
Incretin analogues and co-agonists
Declared label claim
10mg
Manufacture date
25 May 2025
Index quarter
2025-Q4
Independent assays
12
Laboratories involved
Medutest, VendorInvestigate, Janoshik, PeptideMeter
Provenance mix
Buyer-sourced ×9 · Supplier-supplied ×1 · 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 12
Median purity 98.11% n=12
Spread (max − min) 0.74pp n=12
Standard deviation 0.241pp n=12
96.597.197.798.398.999.6100.2This lot (BCH-2505-Y7571)This lot (BCH-2505-Y7571): Q1 97.87, median 98.11, Q3 98.23, n=12n=12All SemaglutideAll Semaglutide: Q1 98.38, median 98.86, Q3 99.30, n=844outlier 96.71outlier 96.74outlier 96.77outlier 96.93outlier 96.96outlier 96.98outlier 96.99outlier 96.99n=844 Purity (% area)
Figure 1. This lot's independent purity results against the whole Semaglutide 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-2025-021316BCH-2505-Y7571Medutest2025-Q498.276.57Buyer-sourced0PASS
AX-2025-021317BCH-2505-Y7571VendorInvestigate2025-Q497.875.4893.5Buyer-sourced0PASS
AX-2026-043642BCH-2505-Y7571Janoshik2025-Q498.026.3299.6Buyer-sourced0PASS
AX-2025-021318BCH-2505-Y7571Janoshik2025-Q498.445.9395.6Supplier-supplied0PASS
AX-2025-021319BCH-2505-Y7571Janoshik2025-Q498.206.29Buyer-sourced0PASS
AX-2025-021320BCH-2505-Y7571Janoshik2025-Q497.786.4188.9Laboratory-retained1MARGINAL
AX-2025-021321BCH-2505-Y7571PeptideMeter2025-Q497.706.42Buyer-sourced0PASS
AX-2025-021322BCH-2505-Y7571PeptideMeter2025-Q498.066.31Buyer-sourced0PASS
AX-2025-021323BCH-2505-Y7571PeptideMeter2025-Q497.866.29Buyer-sourced0PASS
AX-2025-021324BCH-2505-Y7571PeptideMeter2025-Q498.156.0592.1Buyer-sourced0PASS
AX-2025-021325BCH-2505-Y7571Janoshik2025-Q498.226.9699.5Buyer-sourced0PASS
AX-2025-021326BCH-2505-Y7571Medutest2025-Q498.406.10Laboratory-retained0PASS
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
Medutest298.27, 98.4098.3425min+0.0898.26
VendorInvestigate197.8797.8732min-0.1197.98
Janoshik598.02, 98.44, 98.20, 97.78, 98.2298.2030min+0.0098.20
PeptideMeter497.70, 98.06, 97.86, 98.1597.9628min-0.0598.01

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)98.2798.27divergence +0.16 pp vs batch median
Total impurities (% area)not stated1.73
Largest single impurity (% area)not stated1.03
Water (%)not stated6.57
Counter-ion (%)not stated11.16
Peptide content (%w/w)not statednot determined
Endotoxin (EU/mg)not stated0.33
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-Aib8]-diastereomer12 / 120.560.06–1.38
C18 diacid mono-ester12 / 120.260.09–0.52
des-AEEA semaglutide (−145 Da)12 / 120.470.18–1.02
deamidated (Asn→Asp, +1 Da)12 / 120.120.03–0.28
des-His1 truncate (−137 Da)12 / 120.220.01–0.62
semaglutide dimer6 / 120.100.09–0.11
Met(O) sulfoxide (+16 Da)6 / 120.070.06–0.08
Section 7

What this rollup does not establish