AssayIndex

WXT-2504-L4924

Liraglutide · 15 mg declared · WuXi TIDES (WuXi AppTec Testing Division) · manufactured 28 Apr 2025

CHARACTERISED
Lot code
WXT-2504-L4924
Supplier
WXT — WuXi TIDES (WuXi AppTec Testing Division)
Compound
Liraglutide
Compound class
Incretin analogues and co-agonists
Declared label claim
15mg
Manufacture date
28 Apr 2025
Index quarter
2025-Q3
Independent assays
9
Laboratories involved
Medutest, Janoshik, Kestrel, Nordanalyt
Provenance mix
Buyer-sourced ×3 · Supplier-supplied ×5 · 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 9
Median purity 96.78% n=9
Spread (max − min) 0.74pp n=9
Standard deviation 0.273pp n=9
96.296.897.598.298.999.5100.2This lot (WXT-2504-L4924)This lot (WXT-2504-L4924): Q1 96.70, median 96.78, Q3 97.17, n=9n=9All LiraglutideAll Liraglutide: Q1 98.45, median 99.02, Q3 99.53, n=154outlier 96.45outlier 96.59outlier 96.70outlier 96.74outlier 96.78outlier 96.78n=154 Purity (% area)
Figure 1. This lot's independent purity results against the whole Liraglutide record set in the index. The vertical line is the index acceptance specification for the incretin analogues and co-agonists class, 97.5 % 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 9

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-2025-021059WXT-2504-L4924Medutest2025-Q396.705.85Supplier-supplied1FAIL
AX-2025-021060WXT-2504-L4924Janoshik2025-Q396.786.07Buyer-sourced1FAIL
AX-2025-021061WXT-2504-L4924Janoshik2025-Q396.456.76Buyer-sourced2FAIL
AX-2025-021062WXT-2504-L4924Janoshik2025-Q397.196.2698.8Supplier-supplied2FAIL
AX-2025-021063WXT-2504-L4924Janoshik2025-Q397.176.30Supplier-supplied1FAIL
AX-2025-021064WXT-2504-L4924Kestrel2025-Q397.186.6096.1Supplier-supplied1FAIL
AX-2025-021065WXT-2504-L4924Nordanalyt2025-Q396.745.91103.8Laboratory-retained1FAIL
AX-2025-021066WXT-2504-L4924Janoshik2025-Q396.785.60107.0Buyer-sourced1FAIL
AX-2025-021067WXT-2504-L4924Janoshik2025-Q396.596.5798.0Supplier-supplied1FAIL
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
Medutest196.7096.7025min+0.0896.62
Janoshik696.78, 96.45, 97.19, 97.17, 96.78, 96.5996.7830min+0.0096.78
Kestrel197.1897.1815min+0.2496.94
Nordanalyt196.7496.7435min+0.0296.72

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)97.596.70divergence +0.72 pp vs batch median
Total impurities (% area)2.503.30
Largest single impurity (% area)1.811.19
Water (%)not stated5.85
Counter-ion (%)not stated4.45
Peptide content (%w/w)not statednot determined
Endotoxin (EU/mg)not statednot 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
des-His1 truncate (−137 Da)9 / 91.281.02–1.93
γ-Glu regioisomer9 / 90.740.03–0.93
des-palmitoyl liraglutide (−238 Da)9 / 90.640.51–0.82
deamidated (Asn→Asp, +1 Da)9 / 90.350.06–0.43
liraglutide dimer9 / 90.160.12–0.33
palmitoyl bis-adduct (+238 Da)9 / 90.090.04–0.11
Section 7

What this rollup does not establish