AssayIndex

WWB-2507-X4677

SS-31 (Elamipretide) · 20 mg declared · Wuhan Wansheng Biotechnology Co., Ltd. · manufactured 01 Jul 2025

SINGLE TEST
Lot code
WWB-2507-X4677
Supplier
WWB — Wuhan Wansheng Biotechnology Co., Ltd.
Compound
SS-31 (Elamipretide)
Compound class
Metabolic and mitochondrial peptides
Declared label claim
20mg
Manufacture date
01 Jul 2025
Index quarter
2025-Q3
Independent assays
1
Laboratories involved
Janoshik
Provenance mix
Supplier-supplied ×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 1
Median purity 99.71% n=1
Spread (max − min) n<2 n=1
Standard deviation n<3 n=1
96.597.197.798.399.099.6100.2All SS-31 (Elamipretide)All SS-31 (Elamipretide): Q1 98.57, median 99.42, Q3 99.93, n=97n=97 Purity (% area)
Figure 1. This lot's independent purity results against the whole SS-31 (Elamipretide) record set in the index. The vertical line is the index acceptance specification for the metabolic and mitochondrial 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 1

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-2025-018559WWB-2507-X4677Janoshik2025-Q399.714.61Supplier-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
Janoshik199.7199.7130min+0.0099.71

A single laboratory assayed this lot, so it contributes no paired comparison and the bias-adjusted column is a subtraction rather than a measurement.

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)99.9099.71divergence +0.19 pp vs batch median
Total impurities (% area)not stated0.29
Largest single impurity (% area)not stated0.11
Water (%)not stated4.61
Counter-ion (%)3.28.81
Peptide content (%w/w)92.7not determined
Endotoxin (EU/mg)0.33not determined
Method stated on certificateNOno method section — the result cannot be reconciled against any other
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-Dmt (−193 Da)1 / 10.11
acetyl adduct (+42 Da)1 / 10.10
C-terminal free acid (+1 Da)1 / 10.05
[D-Arg1]-epimer1 / 10.03
Section 7

What this rollup does not establish