AssayIndex

WXT-2502-A5571

TB-500 · 5 mg declared · WuXi TIDES (WuXi AppTec Testing Division) · manufactured 05 Feb 2025

CHARACTERISED
Lot code
WXT-2502-A5571
Supplier
WXT — WuXi TIDES (WuXi AppTec Testing Division)
Compound
TB-500
Compound class
Tissue-repair and immunomodulatory peptides
Declared label claim
5mg
Manufacture date
05 Feb 2025
Index quarter
2025-Q3
Independent assays
11
Laboratories involved
PeptideMeter, Janoshik, Kestrel, Nordanalyt
Provenance mix
Buyer-sourced ×2 · Supplier-supplied ×9
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 11
Median purity 98.29% n=11
Spread (max − min) 1.65pp n=11
Standard deviation 0.532pp n=11
97.297.798.298.799.299.6100.1This lot (WXT-2502-A5571)This lot (WXT-2502-A5571): Q1 97.98, median 98.29, Q3 98.72, n=11n=11All TB-500All TB-500: Q1 98.99, median 99.47, Q3 99.81, n=356outlier 97.40outlier 97.48outlier 97.52outlier 97.62outlier 97.75outlier 97.75n=356 Purity (% area)
Figure 1. This lot's independent purity results against the whole TB-500 record set in the index. The vertical line is the index acceptance specification for the tissue-repair and immunomodulatory peptides class, 98.5 % 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 11

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-2025-021152WXT-2502-A5571PeptideMeter2025-Q397.522.50102.4Supplier-supplied2FAIL
AX-2025-021153WXT-2502-A5571Janoshik2025-Q397.852.4791.5Buyer-sourced1FAIL
AX-2025-021154WXT-2502-A5571Janoshik2025-Q398.213.31Supplier-supplied1FAIL
AX-2025-021155WXT-2502-A5571Janoshik2025-Q398.302.70102.5Supplier-supplied2FAIL
AX-2025-021156WXT-2502-A5571PeptideMeter2025-Q398.462.7994.2Supplier-supplied2FAIL
AX-2025-021157WXT-2502-A5571Kestrel2025-Q398.062.92103.5Buyer-sourced1FAIL
AX-2025-021158WXT-2502-A5571Nordanalyt2025-Q398.292.6698.5Supplier-supplied1FAIL
AX-2025-021159WXT-2502-A5571Kestrel2025-Q399.072.87Supplier-supplied1MARGINAL
AX-2025-021160WXT-2502-A5571Janoshik2025-Q399.172.90107.1Supplier-supplied1MARGINAL
AX-2025-021161WXT-2502-A5571Janoshik2025-Q397.912.7194.0Supplier-supplied1FAIL
AX-2025-021162WXT-2502-A5571Kestrel2025-Q398.972.9190.3Supplier-supplied2FAIL
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
PeptideMeter297.52, 98.4697.9928min-0.0598.04
Janoshik597.85, 98.21, 98.30, 99.17, 97.9198.2130min+0.0098.21
Kestrel398.06, 99.07, 98.9798.9715min+0.2498.73
Nordanalyt198.2998.2935min+0.0298.27

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)98.5897.52divergence +0.29 pp vs batch median
Total impurities (% area)1.422.48
Largest single impurity (% area)0.541.06
Water (%)0.92.50
Counter-ion (%)not stated4.68
Peptide content (%w/w)not stated92.30
Endotoxin (EU/mg)0.36not 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
des-Gln truncate (−128 Da)11 / 110.720.34–1.06
C-terminal amide (−1 Da)11 / 110.570.25–0.97
des-acetyl TB-500 (−42 Da)11 / 110.190.08–0.44
[D-Thr]-diastereomer11 / 110.160.07–0.33
Section 7

What this rollup does not establish