AssayIndex

GLBI-2507-R8080

SS-31 (Elamipretide) · 20 mg declared · GL Biochem (Shanghai) Ltd. · manufactured 04 Jul 2025

CHARACTERISEDSHARED BULK
Lot code
GLBI-2507-R8080
Supplier
GL Biochem — GL Biochem (Shanghai) Ltd.
Compound
SS-31 (Elamipretide)
Compound class
Metabolic and mitochondrial peptides
Declared label claim
20mg
Manufacture date
04 Jul 2025
Index quarter
2025-Q3
Independent assays
5
Laboratories involved
VendorInvestigate, Janoshik, PeptideMeter
Provenance mix
Buyer-sourced ×5
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 5
Median purity 98.33% n=5
Spread (max − min) 0.45pp n=5
Standard deviation 0.187pp n=5
96.997.598.098.599.199.6100.2This lot (GLBI-2507-R8080)This lot (GLBI-2507-R8080): Q1 98.23, median 98.33, Q3 98.50, n=5n=5All SS-31 (Elamipretide)All SS-31 (Elamipretide): Q1 98.81, median 99.53, Q3 99.80, n=124outlier 97.16n=124 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 5

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-2025-020613GLBI-2507-R8080VendorInvestigate2025-Q398.093.16100.8Buyer-sourced1FAIL
AX-2025-020614GLBI-2507-R8080Janoshik2025-Q398.332.81Buyer-sourced1FAIL
AX-2025-020615GLBI-2507-R8080PeptideMeter2025-Q398.503.11Buyer-sourced1MARGINAL
AX-2025-020616GLBI-2507-R8080Janoshik2025-Q398.232.40Buyer-sourced1FAIL
AX-2025-020617GLBI-2507-R8080Janoshik2025-Q398.542.7289.9Buyer-sourced2MARGINAL
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
VendorInvestigate198.0998.0932min-0.1198.20
Janoshik398.33, 98.23, 98.5498.3330min+0.0098.33
PeptideMeter198.5098.5028min-0.0598.55

This lot contributes 3 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)98.6198.09divergence +0.28 pp vs batch median
Total impurities (% area)not stated1.91
Largest single impurity (% area)not stated0.79
Water (%)not stated3.16
Counter-ion (%)8.26.40
Peptide content (%w/w)87.789.55
Endotoxin (EU/mg)1.00not 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
acetyl adduct (+42 Da)5 / 50.610.37–0.79
C-terminal free acid (+1 Da)5 / 50.620.47–1.05
des-Dmt (−193 Da)5 / 50.230.14–0.30
[D-Arg1]-epimer5 / 50.170.15–0.20
Section 6

Shared-bulk links

Rule AX-R09. Where impurity fingerprints and latent composition match across companies, the index treats the material as one bulk and counts it once in aggregates.

LotSold byRoleReportsMedian purity
QSC-2502-M6829QSClinked child898.30
FGP-2601-R8955FGPlinked child598.44
GLBI-2507-R8080GL Biochemthis lot598.33
Section 7

What this rollup does not establish