AssayIndex

JEEP-2411-B3841

Liraglutide · 15 mg declared · Guangzhou JEEP Biotechnology Co., Ltd. · manufactured 29 Nov 2024

CHARACTERISED
Lot code
JEEP-2411-B3841
Supplier
JEEP — Guangzhou JEEP Biotechnology Co., Ltd.
Compound
Liraglutide
Compound class
Incretin analogues and co-agonists
Declared label claim
15mg
Manufacture date
29 Nov 2024
Index quarter
2025-Q2
Independent assays
12
Laboratories involved
Kestrel, Janoshik, PeptideMeter, Medutest, VendorInvestigate
Provenance mix
Buyer-sourced ×1 · Supplier-supplied ×11
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 99.48% n=12
Spread (max − min) 1.10pp n=12
Standard deviation 0.356pp n=12
96.296.897.598.298.999.5100.2This lot (JEEP-2411-B3841)This lot (JEEP-2411-B3841): Q1 99.24, median 99.48, Q3 99.66, n=12n=12All 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 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-2025-019059JEEP-2411-B3841Kestrel2025-Q299.934.82Supplier-supplied0PASS
AX-2025-019060JEEP-2411-B3841Janoshik2025-Q299.525.2798.1Supplier-supplied0PASS
AX-2025-019061JEEP-2411-B3841PeptideMeter2025-Q299.925.11104.5Supplier-supplied0PASS
AX-2025-019062JEEP-2411-B3841Janoshik2025-Q299.444.98105.8Supplier-supplied0PASS
AX-2025-019063JEEP-2411-B3841Medutest2025-Q299.535.1996.0Supplier-supplied0PASS
AX-2025-019064JEEP-2411-B3841VendorInvestigate2025-Q298.975.26106.3Buyer-sourced0PASS
AX-2025-019065JEEP-2411-B3841Janoshik2025-Q298.834.94Supplier-supplied0PASS
AX-2025-019066JEEP-2411-B3841Janoshik2025-Q299.614.38Supplier-supplied0PASS
AX-2025-019067JEEP-2411-B3841Janoshik2025-Q299.115.09Supplier-supplied0PASS
AX-2025-019068JEEP-2411-B3841Medutest2025-Q299.444.44Supplier-supplied0PASS
AX-2025-019069JEEP-2411-B3841Janoshik2025-Q299.284.75Supplier-supplied0PASS
AX-2025-019070JEEP-2411-B3841Janoshik2025-Q299.835.2293.7Supplier-supplied0PASS
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
Kestrel199.9399.9315min+0.2499.69
Janoshik799.52, 99.44, 98.83, 99.61, 99.11, 99.28, 99.8399.4430min+0.0099.44
PeptideMeter199.9299.9228min-0.0599.97
Medutest299.53, 99.4499.4825min+0.0899.41
VendorInvestigate198.9798.9732min-0.1199.08

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)99.5799.93divergence +0.09 pp vs batch median
Total impurities (% area)0.430.07
Largest single impurity (% area)0.270.05
Water (%)2.84.82
Counter-ion (%)5.55.57
Peptide content (%w/w)91.1not determined
Endotoxin (EU/mg)not stated0.21
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
deamidated (Asn→Asp, +1 Da)12 / 120.050.04–0.63
γ-Glu regioisomer11 / 120.030.02–0.32
des-palmitoyl liraglutide (−238 Da)10 / 120.100.02–0.19
des-His1 truncate (−137 Da)6 / 120.270.08–0.72
palmitoyl bis-adduct (+238 Da)6 / 120.050.01–0.10
liraglutide dimer3 / 120.040.03–0.05
Section 7

What this rollup does not establish