AssayIndex

CPC-2504-E9752

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

PARTIALLY CHARACTERISED
Lot code
CPC-2504-E9752
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
2
Laboratories involved
Medutest, PeptideMeter
Provenance mix
Buyer-sourced ×1 · 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 2
Median purity 99.88% n=2
Spread (max − min) 0.11pp n=2
Standard deviation n<3 n=2
96.997.598.098.599.199.6100.2This lot (CPC-2504-E9752)This lot (CPC-2504-E9752): Q1 99.85, median 99.88, Q3 99.90, n=2n=2All 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 2

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-2025-020776CPC-2504-E9752Medutest2025-Q399.825.2793.2Buyer-sourced0PASS
AX-2025-020777CPC-2504-E9752PeptideMeter2025-Q399.934.23Supplier-supplied0PASS
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
Medutest199.8299.8225min+0.0899.74
PeptideMeter199.9399.9328min-0.0599.98

This lot contributes 1 paired comparison 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)99.9099.82divergence +0.02 pp vs batch median
Total impurities (% area)0.100.18
Largest single impurity (% area)0.070.11
Water (%)not stated5.27
Counter-ion (%)not stated6.34
Peptide content (%w/w)not stated88.02
Endotoxin (EU/mg)not statednot 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)2 / 20.070.03–0.11
[D-Arg1]-epimer2 / 20.040.03–0.04
acetyl adduct (+42 Da)1 / 20.04
Section 7

What this rollup does not establish