AssayIndex

SSA-2403-V6258

LL-37 · 10 mg declared · Shanghai Sigma-Audley New Material Technology Co., Ltd. · manufactured 12 Mar 2024

CHARACTERISED
Lot code
SSA-2403-V6258
Supplier
SSA — Shanghai Sigma-Audley New Material Technology Co., Ltd.
Compound
LL-37
Compound class
Tissue-repair and immunomodulatory peptides
Declared label claim
10mg
Manufacture date
12 Mar 2024
Index quarter
2024-Q2
Independent assays
12
Laboratories involved
Janoshik, VendorInvestigate, Medutest, Nordanalyt, PeptideMeter
Provenance mix
Buyer-sourced ×3 · 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 12
Median purity 98.31% n=12
Spread (max − min) 1.33pp n=12
Standard deviation 0.432pp n=12
97.397.898.398.799.299.7100.1This lot (SSA-2403-V6258)This lot (SSA-2403-V6258): Q1 97.97, median 98.31, Q3 98.66, n=12n=12All LL-37All LL-37: Q1 98.18, median 98.61, Q3 99.17, n=36n=36 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 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-2024-005174SSA-2403-V6258Janoshik2024-Q297.982.11102.6Buyer-sourced1MARGINAL
AX-2024-005175SSA-2403-V6258VendorInvestigate2024-Q297.682.54Buyer-sourced0PASS
AX-2024-005176SSA-2403-V6258Medutest2024-Q298.821.96Supplier-supplied1MARGINAL
AX-2024-005177SSA-2403-V6258Janoshik2024-Q298.272.61Supplier-supplied0PASS
AX-2024-005178SSA-2403-V6258Janoshik2024-Q297.952.2995.7Supplier-supplied0PASS
AX-2024-005179SSA-2403-V6258Nordanalyt2024-Q298.922.8198.6Supplier-supplied1MARGINAL
AX-2024-005180SSA-2403-V6258Janoshik2024-Q299.012.48106.5Supplier-supplied1MARGINAL
AX-2024-005181SSA-2403-V6258Janoshik2024-Q298.601.92Supplier-supplied0PASS
AX-2024-005182SSA-2403-V6258PeptideMeter2024-Q297.862.2995.4Buyer-sourced1MARGINAL
AX-2024-005183SSA-2403-V6258Janoshik2024-Q298.332.50Supplier-supplied1MARGINAL
AX-2024-005184SSA-2403-V6258Janoshik2024-Q298.462.31Supplier-supplied1MARGINAL
AX-2024-005185SSA-2403-V6258Janoshik2024-Q298.282.11Supplier-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
Janoshik897.98, 98.27, 97.95, 99.01, 98.60, 98.33, 98.46, 98.2898.3130min+0.0098.31
VendorInvestigate197.6897.6832min-0.1197.79
Medutest198.8298.8225min+0.0898.74
Nordanalyt198.9298.9235min+0.0298.90
PeptideMeter197.8697.8628min-0.0597.91

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)98.7497.98divergence +0.43 pp vs batch median
Total impurities (% area)not stated2.02
Largest single impurity (% area)not stated1.18
Water (%)not stated2.11
Counter-ion (%)not stated6.88
Peptide content (%w/w)not stated90.81
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
truncated (1-31)12 / 120.520.21–1.25
aggregated multimer12 / 120.560.22–1.40
des-Leu1 (−113 Da)12 / 120.100.05–0.20
deamidated (+1 Da)12 / 120.120.06–0.17
trifluoroacetyl adduct (+96 Da)12 / 120.080.03–0.19
Section 7

What this rollup does not establish