AssayIndex

CPC-2504-E1788

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

SINGLE TESTSHARED BULK
Lot code
CPC-2504-E1788
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
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 98.18% 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-2025-020848CPC-2504-E1788Janoshik2025-Q398.184.51Supplier-supplied3FAIL
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
Janoshik198.1898.1830min+0.0098.18

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)98.598.18divergence +0.32 pp vs batch median
Total impurities (% area)1.501.82
Largest single impurity (% area)not stated0.75
Water (%)2.24.51
Counter-ion (%)not stated9.22
Peptide content (%w/w)93.0not determined
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
acetyl adduct (+42 Da)1 / 10.75
C-terminal free acid (+1 Da)1 / 10.59
des-Dmt (−193 Da)1 / 10.29
[D-Arg1]-epimer1 / 10.19
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
GLBI-2507-R8450GL Biochemparent bulk698.18
CPC-2504-E1788CPCthis lot198.18
Section 7

What this rollup does not establish