AssayIndex

TFC-2406-V7696

Liraglutide · 5 mg declared · Tianjin Finder Chemical Co., Ltd. · manufactured 30 Jun 2024

CHARACTERISED
Lot code
TFC-2406-V7696
Supplier
TFC — Tianjin Finder Chemical Co., Ltd.
Compound
Liraglutide
Compound class
Incretin analogues and co-agonists
Declared label claim
5mg
Manufacture date
30 Jun 2024
Index quarter
2024-Q3
Independent assays
14
Laboratories involved
VendorInvestigate, PeptideMeter, Kestrel, Medutest, Janoshik
Provenance mix
Buyer-sourced ×1 · Supplier-supplied ×11 · 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 14
Median purity 99.57% n=14
Spread (max − min) 0.93pp n=14
Standard deviation 0.308pp n=14
96.296.897.598.298.999.5100.2This lot (TFC-2406-V7696)This lot (TFC-2406-V7696): Q1 99.23, median 99.57, Q3 99.69, n=14n=14All 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 14

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-2024-004694TFC-2406-V7696VendorInvestigate2024-Q399.725.42101.0Laboratory-retained2MARGINAL
AX-2024-004695TFC-2406-V7696PeptideMeter2024-Q399.615.16Supplier-supplied2MARGINAL
AX-2024-004696TFC-2406-V7696PeptideMeter2024-Q399.334.68Supplier-supplied1MARGINAL
AX-2024-004697TFC-2406-V7696PeptideMeter2024-Q399.425.43Supplier-supplied2MARGINAL
AX-2024-004698TFC-2406-V7696Kestrel2024-Q399.935.60103.0Supplier-supplied1MARGINAL
AX-2024-004699TFC-2406-V7696Medutest2024-Q399.015.2492.3Supplier-supplied2FAIL
AX-2024-004700TFC-2406-V7696Janoshik2024-Q399.585.6999.5Supplier-supplied1FAIL
AX-2024-004701TFC-2406-V7696Medutest2024-Q399.565.40101.6Laboratory-retained1MARGINAL
AX-2024-004702TFC-2406-V7696PeptideMeter2024-Q399.005.50101.6Supplier-supplied1MARGINAL
AX-2024-004703TFC-2406-V7696Janoshik2024-Q399.895.33Supplier-supplied1MARGINAL
AX-2024-004704TFC-2406-V7696Janoshik2024-Q399.844.70Supplier-supplied1MARGINAL
AX-2024-004705TFC-2406-V7696Janoshik2024-Q399.595.43102.0Supplier-supplied1MARGINAL
AX-2024-004706TFC-2406-V7696Medutest2024-Q399.205.12106.7Buyer-sourced1MARGINAL
AX-2024-004707TFC-2406-V7696Janoshik2024-Q399.205.41107.0Supplier-supplied1MARGINAL
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
VendorInvestigate199.7299.7232min-0.1199.83
PeptideMeter499.61, 99.33, 99.42, 99.0099.3828min-0.0599.42
Kestrel199.9399.9315min+0.2499.69
Medutest399.01, 99.56, 99.2099.2025min+0.0899.12
Janoshik599.58, 99.89, 99.84, 99.59, 99.2099.5930min+0.0099.59

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)100.099.72divergence +0.43 pp vs batch median
Total impurities (% area)0.000.28
Largest single impurity (% area)0.000.20
Water (%)not stated5.42
Counter-ion (%)not stated10.44
Peptide content (%w/w)not stated83.60
Endotoxin (EU/mg)not stated0.32
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)14 / 140.070.02–0.33
γ-Glu regioisomer13 / 140.040.01–0.18
palmitoyl bis-adduct (+238 Da)11 / 140.040.01–0.09
liraglutide dimer9 / 140.200.04–0.41
des-palmitoyl liraglutide (−238 Da)7 / 140.300.08–0.46
des-His1 truncate (−137 Da)3 / 140.020.02–0.03
Section 7

What this rollup does not establish