AssayIndex

CPC-2504-E2084

SS-31 (Elamipretide) · 50 mg declared · Chinese Peptide Company Co., Ltd. · manufactured 12 Apr 2025

CHARACTERISED
Lot code
CPC-2504-E2084
Supplier
CPC — Chinese Peptide Company Co., Ltd.
Compound
SS-31 (Elamipretide)
Compound class
Metabolic and mitochondrial peptides
Declared label claim
50mg
Manufacture date
12 Apr 2025
Index quarter
2025-Q3
Independent assays
12
Laboratories involved
PeptideMeter, Kestrel, VendorInvestigate, Janoshik, Medutest, Nordanalyt
Provenance mix
Buyer-sourced ×10 · 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 12
Median purity 99.74% n=12
Spread (max − min) 1.02pp n=12
Standard deviation 0.300pp n=12
96.797.397.998.499.099.6100.2This lot (CPC-2504-E2084)This lot (CPC-2504-E2084): Q1 99.53, median 99.73, Q3 99.91, n=12outlier 98.91n=12All SS-31 (Elamipretide)All SS-31 (Elamipretide): Q1 98.70, median 99.40, Q3 99.72, n=99outlier 96.93outlier 96.97outlier 97.08n=99 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 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-2025-020958CPC-2504-E2084PeptideMeter2025-Q399.424.88Buyer-sourced0PASS
AX-2025-020959CPC-2504-E2084Kestrel2025-Q399.934.30104.6Buyer-sourced0PASS
AX-2025-020960CPC-2504-E2084VendorInvestigate2025-Q398.915.00103.1Buyer-sourced0PASS
AX-2025-020961CPC-2504-E2084Janoshik2025-Q399.464.64103.1Buyer-sourced0PASS
AX-2025-020962CPC-2504-E2084Medutest2025-Q399.935.18Buyer-sourced0PASS
AX-2025-020963CPC-2504-E2084Medutest2025-Q399.784.29106.2Buyer-sourced0PASS
AX-2025-020964CPC-2504-E2084PeptideMeter2025-Q399.904.42Buyer-sourced0PASS
AX-2025-020965CPC-2504-E2084Nordanalyt2025-Q399.934.31Supplier-supplied0PASS
AX-2025-020966CPC-2504-E2084Janoshik2025-Q399.554.3889.5Buyer-sourced1MARGINAL
AX-2025-020967CPC-2504-E2084Medutest2025-Q399.613.98Buyer-sourced0PASS
AX-2025-020968CPC-2504-E2084Medutest2025-Q399.824.60Supplier-supplied0PASS
AX-2025-020969CPC-2504-E2084Janoshik2025-Q399.695.3993.5Buyer-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
PeptideMeter299.42, 99.9099.6628min-0.0599.71
Kestrel199.9399.9315min+0.2499.69
VendorInvestigate198.9198.9132min-0.1199.02
Janoshik399.46, 99.55, 99.6999.5530min+0.0099.55
Medutest499.93, 99.78, 99.61, 99.8299.8025min+0.0899.72
Nordanalyt199.9399.9335min+0.0299.91

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)99.9099.42divergence +0.16 pp vs batch median
Total impurities (% area)0.100.58
Largest single impurity (% area)0.060.24
Water (%)3.44.88
Counter-ion (%)7.65.46
Peptide content (%w/w)88.4not determined
Endotoxin (EU/mg)not stated0.92
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
[D-Arg1]-epimer12 / 120.130.02–0.44
des-Dmt (−193 Da)12 / 120.080.03–0.40
acetyl adduct (+42 Da)8 / 120.040.02–0.14
C-terminal free acid (+1 Da)7 / 120.050.02–0.11
Section 7

What this rollup does not establish