AssayIndex

GSP-2410-U3278

LL-37 · 10 mg declared · GenScript Biotech Corporation · manufactured 03 Oct 2024

CHARACTERISED
Lot code
GSP-2410-U3278
Supplier
GSP — GenScript Biotech Corporation
Compound
LL-37
Compound class
Tissue-repair and immunomodulatory peptides
Declared label claim
10mg
Manufacture date
03 Oct 2024
Index quarter
2024-Q4
Independent assays
8
Laboratories involved
Janoshik, Kestrel, Medutest, PeptideMeter
Provenance mix
Buyer-sourced ×7 · 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 8
Median purity 98.12% n=8
Spread (max − min) 0.56pp n=8
Standard deviation 0.197pp n=8
97.697.998.298.698.999.399.6This lot (GSP-2410-U3278)This lot (GSP-2410-U3278): Q1 97.99, median 98.12, Q3 98.30, n=8n=8All LL-37All LL-37: Q1 98.08, median 98.29, Q3 98.50, n=35outlier 99.17outlier 99.33outlier 99.47n=35 Purity (% area)
Figure 1. This lot's independent purity results against the whole LL-37 record set in the index. The vertical line is the index acceptance specification for the tissue-repair and immunomodulatory peptides class, 96.5 % 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 8

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-2024-004573GSP-2410-U3278Janoshik2024-Q498.365.3588.8Buyer-sourced1MARGINAL
AX-2024-004574GSP-2410-U3278Janoshik2024-Q497.955.3794.5Buyer-sourced0PASS
AX-2024-004575GSP-2410-U3278Kestrel2024-Q498.306.01Buyer-sourced1FAIL
AX-2024-004576GSP-2410-U3278Kestrel2024-Q498.315.58Buyer-sourced1FAIL
AX-2024-004577GSP-2410-U3278Janoshik2024-Q498.005.87Buyer-sourced0PASS
AX-2024-004578GSP-2410-U3278Medutest2024-Q498.145.9991.8Buyer-sourced0PASS
AX-2024-004579GSP-2410-U3278PeptideMeter2024-Q498.104.8491.6Laboratory-retained0PASS
AX-2024-004580GSP-2410-U3278PeptideMeter2024-Q497.805.75103.5Buyer-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
Janoshik398.36, 97.95, 98.0098.0030min+0.0098.00
Kestrel298.30, 98.3198.3115min+0.2498.07
Medutest198.1498.1425min+0.0898.06
PeptideMeter298.10, 97.8097.9528min-0.0598.00

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)97.9398.36divergence -0.19 pp vs batch median
Total impurities (% area)2.071.64
Largest single impurity (% area)not stated0.86
Water (%)4.35.35
Counter-ion (%)8.87.05
Peptide content (%w/w)86.386.99
Endotoxin (EU/mg)not statednot 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-Leu1 (−113 Da)8 / 80.560.20–1.04
aggregated multimer8 / 80.230.07–0.43
deamidated (+1 Da)8 / 80.140.03–0.30
trifluoroacetyl adduct (+96 Da)8 / 80.560.10–1.30
truncated (1-31)8 / 80.250.08–0.51
Section 7

What this rollup does not establish