AssayIndex

SSA-2408-G7111

SS-31 (Elamipretide) · 10 mg declared · Shanghai Sigma-Audley New Material Technology Co., Ltd. · manufactured 02 Aug 2024

CHARACTERISED
Lot code
SSA-2408-G7111
Supplier
SSA — Shanghai Sigma-Audley New Material Technology Co., Ltd.
Compound
SS-31 (Elamipretide)
Compound class
Metabolic and mitochondrial peptides
Declared label claim
10mg
Manufacture date
02 Aug 2024
Index quarter
2024-Q3
Independent assays
14
Laboratories involved
PeptideMeter, Janoshik, Medutest, Kestrel, VendorInvestigate
Provenance mix
Buyer-sourced ×13 · 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 14
Median purity 97.97% n=14
Spread (max − min) 1.59pp n=14
Standard deviation 0.355pp n=14
96.997.598.098.599.199.6100.2This lot (SSA-2408-G7111)This lot (SSA-2408-G7111): Q1 97.77, median 97.97, Q3 98.03, n=14outlier 97.16outlier 98.75n=14All 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 14

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-2024-005066SSA-2408-G7111PeptideMeter2024-Q397.835.7393.3Buyer-sourced0FAIL
AX-2024-005067SSA-2408-G7111Janoshik2024-Q398.116.02100.5Buyer-sourced0FAIL
AX-2024-005068SSA-2408-G7111PeptideMeter2024-Q397.975.8089.9Buyer-sourced1FAIL
AX-2024-005069SSA-2408-G7111Janoshik2024-Q398.016.23Buyer-sourced0FAIL
AX-2024-005070SSA-2408-G7111Medutest2024-Q397.645.96Buyer-sourced0FAIL
AX-2024-005071SSA-2408-G7111Medutest2024-Q397.166.27Buyer-sourced0FAIL
AX-2024-005072SSA-2408-G7111Janoshik2024-Q398.036.5899.5Buyer-sourced0FAIL
AX-2024-005073SSA-2408-G7111PeptideMeter2024-Q398.756.1793.2Supplier-supplied0PASS
AX-2024-005074SSA-2408-G7111Medutest2024-Q397.906.1392.0Buyer-sourced0FAIL
AX-2024-005075SSA-2408-G7111Kestrel2024-Q397.756.4199.9Buyer-sourced0FAIL
AX-2024-005076SSA-2408-G7111VendorInvestigate2024-Q397.686.25Buyer-sourced0FAIL
AX-2024-005077SSA-2408-G7111Janoshik2024-Q397.976.06101.6Buyer-sourced0FAIL
AX-2024-005078SSA-2408-G7111Janoshik2024-Q397.966.5790.8Buyer-sourced0FAIL
AX-2024-005079SSA-2408-G7111Kestrel2024-Q398.296.20103.1Buyer-sourced0FAIL
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
PeptideMeter397.83, 97.97, 98.7597.9728min-0.0598.02
Janoshik598.11, 98.01, 98.03, 97.97, 97.9698.0130min+0.0098.01
Medutest397.64, 97.16, 97.9097.6425min+0.0897.56
Kestrel297.75, 98.2998.0215min+0.2497.78
VendorInvestigate197.6897.6832min-0.1197.79

This lot contributes 10 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)98.4197.83divergence +0.44 pp vs batch median
Total impurities (% area)1.592.17
Largest single impurity (% area)not stated1.17
Water (%)5.25.73
Counter-ion (%)not stated5.75
Peptide content (%w/w)not stated87.88
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
[D-Arg1]-epimer14 / 140.740.18–1.27
acetyl adduct (+42 Da)14 / 140.710.60–1.59
C-terminal free acid (+1 Da)14 / 140.220.14–0.33
des-Dmt (−193 Da)14 / 140.170.10–0.51
Section 7

What this rollup does not establish