AssayIndex

ERP-2509-K8008

TB-500 · 10 mg declared · Shanghai ERP Biotechnology Co., Ltd. · manufactured 10 Sep 2025

CHARACTERISED
Lot code
ERP-2509-K8008
Supplier
ERP — Shanghai ERP Biotechnology Co., Ltd.
Compound
TB-500
Compound class
Tissue-repair and immunomodulatory peptides
Declared label claim
10mg
Manufacture date
10 Sep 2025
Index quarter
2025-Q4
Independent assays
11
Laboratories involved
Kestrel, Nordanalyt, PeptideMeter, Janoshik, VendorInvestigate, Medutest
Provenance mix
Buyer-sourced ×9 · Supplier-supplied ×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 11
Median purity 99.49% n=11
Spread (max − min) 0.84pp n=11
Standard deviation 0.213pp n=11
97.597.998.498.899.299.7100.1This lot (ERP-2509-K8008)This lot (ERP-2509-K8008): Q1 99.41, median 99.49, Q3 99.53, n=11outlier 99.09outlier 99.73outlier 99.93n=11All TB-500All TB-500: Q1 99.10, median 99.52, Q3 99.79, n=317outlier 97.67outlier 97.68outlier 97.75outlier 97.76outlier 97.82outlier 97.85outlier 97.86outlier 97.99outlier 98.02outlier 98.04outlier 98.05n=317 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-2025-020120ERP-2509-K8008Kestrel2025-Q499.401.93—Buyer-sourced0PASS
AX-2025-020121ERP-2509-K8008Nordanalyt2025-Q499.732.6897.2Buyer-sourced0PASS
AX-2025-020122ERP-2509-K8008PeptideMeter2025-Q499.522.31101.6Supplier-supplied0PASS
AX-2025-020123ERP-2509-K8008Janoshik2025-Q499.342.0694.7Buyer-sourced0PASS
AX-2025-020124ERP-2509-K8008Janoshik2025-Q499.522.32—Buyer-sourced0PASS
AX-2025-020125ERP-2509-K8008Janoshik2025-Q499.442.36—Buyer-sourced0PASS
AX-2026-042674ERP-2509-K8008PeptideMeter2025-Q499.932.54106.7Supplier-supplied0PASS
AX-2026-042675ERP-2509-K8008VendorInvestigate2025-Q499.091.76—Buyer-sourced0PASS
AX-2025-020126ERP-2509-K8008Janoshik2025-Q499.422.38—Buyer-sourced0PASS
AX-2025-020127ERP-2509-K8008Medutest2025-Q499.532.5089.2Buyer-sourced1MARGINAL
AX-2025-020128ERP-2509-K8008Janoshik2025-Q499.492.6598.3Buyer-sourced0PASS
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
Kestrel199.4099.4015min+0.2499.16
Nordanalyt199.7399.7335min+0.0299.71
PeptideMeter299.52, 99.9399.7228min-0.0599.77
Janoshik599.34, 99.52, 99.44, 99.42, 99.4999.4430min+0.0099.44
VendorInvestigate199.0999.0932min-0.1199.20
Medutest199.5399.5325min+0.0899.45

This lot contributes 15 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)99.5599.40divergence +0.06 pp vs batch median
Total impurities (% area)0.450.60
Largest single impurity (% area)0.260.40
Water (%)not stated1.93
Counter-ion (%)not stated4.16
Peptide content (%w/w)not statednot determined
Endotoxin (EU/mg)0.160.24
Method stated on certificateYES—column, 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
[D-Thr]-diastereomer11 / 110.320.03–0.49
des-acetyl TB-500 (−42 Da)11 / 110.090.04–0.17
C-terminal amide (−1 Da)10 / 110.050.04–0.17
des-Gln truncate (−128 Da)10 / 110.040.02–0.08
Section 7

What this rollup does not establish