A resolution figure without a stated column and gradient is uninterpretable. Both are on this record, which is why the figure is worth printing at all.
AX-2024-005066
SS-31 (Elamipretide) · 10 mg declared · Shanghai Sigma-Audley New Material Technology Co., Ltd. · lot SSA-2408-G7111
FAILPURITY ONLY
- Report ID
- AX-2024-005066
- Compound
- SS-31 (Elamipretide)
- Compound class
- Metabolic and mitochondrial peptides
- Supplier
- SSA — Shanghai Sigma-Audley New Material Technology Co., Ltd.
- Batch / lot
- SSA-2408-G7111
- Declared label claim
- 10mg
- Laboratory
- PeptideMeter
- Assay date
- 12 Aug 2024
- Submitted
- 30 Aug 2024
- Quarter
- 2024-Q3
- Submitter
- d.perrin
- Sample provenance
- Buyer-sourced
Section 1
Results
Measured against the index acceptance specification for the metabolic and mitochondrial peptides class. A specification is a decision the index made; a result is a measurement. See where each threshold came from.
| Parameter | Method | Result | Unit | Index spec | |
|---|---|---|---|---|---|
| Purity | RP-HPLC, 28 min gradient, 214 nm | 97.83 | % area | ≥ 98.5 | FAIL |
| Total impurities | RP-HPLC, sum of reported peaks | 2.17 | % area | ≤ 1.5 | FAIL |
| Largest single impurity | RP-HPLC — [D-Arg1]-epimer | 1.17 | % area | ≤ 1.00 | FAIL |
| Identity | not ordered on this submission | not determined | — | required for VERIFIED status | NOT TESTED |
| Total peptide content | by difference from the gravimetric mass balance | 87.88 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 85.97 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 10.85 | mg | 10 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 9.328 | mg | 10 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 93.3 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 5.73 | % | ≤ 9.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 5.75 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.64 | % | — | NOT TESTED |
| Endotoxin | not ordered on this submission | not determined | — | ≤ 5.0 | NOT TESTED |
| Sterility | not ordered on this submission | not determined | — | no growth | NOT TESTED |
| Appearance | visual, diffuse light, black and white background | White lyophilised cake, intact | — | white to off-white intact cake | PASS |
| Reconstitution clarity | reconstituted per submitter procedure | Clear, colourless, no visible particulates | — | clear, no visible particulates | PASS |
| pH (reconstituted, 1 mg/mL) | potentiometric, two-point calibration | 5.18 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 28 min gradient | 8.41 | min | 8.39 ± 0.25 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.08 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 67,930 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs [D-Arg1]-epimer | 1.27 | — | no index criterion | REPORTED |
Section 2
Chromatogram and peak integration
The figure is drawn from the table. It is not an independent illustration — if a number in the table changed, the trace would change with it.
| # | Peak | RT | Area (µV·s) | % area | Δ mass (Da) |
|---|---|---|---|---|---|
| 1 | SS-31 (Elamipretide) — main peak | 8.41 | 4,754,841 | 97.83 | — |
| 2 | [D-Arg1]-epimer | 8.24 | 56,866 | 1.17 | 0.000 |
| 3 | acetyl adduct (+42 Da) | 8.91 | 32,078 | 0.66 | +42.011 |
| 4 | C-terminal free acid (+1 Da) | 8.60 | 10,693 | 0.22 | +0.984 |
| 5 | des-Dmt (−193 Da) | 7.74 | 5,832 | 0.12 | -193.110 |
| Closure check — purity + Σ impurities | 100.00 | CLOSES | |||
Reporting threshold 0.05 % area. Peaks below it are not reported and are therefore excluded from the total, which overstates purity by their sum — see peak integration.
Section 4
Gravimetric mass balance
Water, counter-ion, residual and total peptide content are exhaustive and mutually exclusive categories. They must account for 100 % of the cake mass. The index closes this to within 0.02 pp and the build asserts it.
| Component | Determination | %w/w of cake |
|---|---|---|
| Water | Karl Fischer | 5.73 |
| Counter-ion (acetate) | ion chromatography | 5.75 |
| Residual solvent + inorganic residue | estimated | 0.64 |
| Total peptide content | by difference | 87.88 |
| Total | 100.00 CLOSES | |
Supplier certificate, as declared
The supplier's own figures for this lot, beside the independent measurement. Divergence is assessed against the batch median, not against this single report — see rule AX-R05.
| Figure | Supplier COA | This report | Index note |
|---|---|---|---|
| Purity (% area) | 98.41 | 97.83 | divergence +0.44 pp vs batch median |
| Total impurities (% area) | 1.59 | 2.17 | |
| Largest single impurity (% area) | not stated | 1.17 | |
| Water (%) | 5.2 | 5.73 | |
| Counter-ion (%) | not stated | 5.75 | |
| Peptide content (%w/w) | not stated | 87.88 | |
| Endotoxin (EU/mg) | not stated | not determined | |
| Method stated on certificate | NO | — | no method section — the result cannot be reconciled against any other |
Section 5
Provenance and caveats
Where a sample came from changes the weight of the evidence. The index treats it as a first-class field.
- Sample provenance
- Buyer-sourced
- Evidentiary weight
- Strongest available evidence in this index.
- Chain of custody
- Domestic warehouse despatch → submitter (2–8 °C, 26 d) → laboratory (courier, cold pack, 9 d) → assay.
- Assay date
- 12 Aug 2024
- Submitted to the index
- 30 Aug 2024
- Laboratory
- PeptideMeter, Tallinn, Estonia
- Method basis
- 28 min gradient · high-resolution MS
- Verification status
- PURITY ONLY
Section 6
Annotations 2
Signed technical comments from index contributors. Not a discussion forum — annotations question or contextualise the result, and the data team replies where a reply is warranted.
Residual solvent to the ICH limits is a stated requirement in regulated manufacture and an optional extra here. It is the slot most likely to hide something.
Section 7
Related records
Same batch — lot SSA-2408-G7111 n=14
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2024-005067 | SSA-2408-G7111 | Janoshik | 2024-Q3 | 98.11 | 6.02 | 100.5 | Buyer-sourced | 0 | FAIL |
| AX-2024-005068 | SSA-2408-G7111 | PeptideMeter | 2024-Q3 | 97.97 | 5.80 | 89.9 | Buyer-sourced | 1 | FAIL |
| AX-2024-005069 | SSA-2408-G7111 | Janoshik | 2024-Q3 | 98.01 | 6.23 | — | Buyer-sourced | 0 | FAIL |
| AX-2024-005070 | SSA-2408-G7111 | Medutest | 2024-Q3 | 97.64 | 5.96 | — | Buyer-sourced | 0 | FAIL |
| AX-2024-005071 | SSA-2408-G7111 | Medutest | 2024-Q3 | 97.16 | 6.27 | — | Buyer-sourced | 0 | FAIL |
| AX-2024-005072 | SSA-2408-G7111 | Janoshik | 2024-Q3 | 98.03 | 6.58 | 99.5 | Buyer-sourced | 0 | FAIL |
| AX-2024-005073 | SSA-2408-G7111 | PeptideMeter | 2024-Q3 | 98.75 | 6.17 | 93.2 | Supplier-supplied | 0 | PASS |
| AX-2024-005074 | SSA-2408-G7111 | Medutest | 2024-Q3 | 97.90 | 6.13 | 92.0 | Buyer-sourced | 0 | FAIL |
| AX-2024-005075 | SSA-2408-G7111 | Kestrel | 2024-Q3 | 97.75 | 6.41 | 99.9 | Buyer-sourced | 0 | FAIL |
| AX-2024-005076 | SSA-2408-G7111 | VendorInvestigate | 2024-Q3 | 97.68 | 6.25 | — | Buyer-sourced | 0 | FAIL |
| AX-2024-005077 | SSA-2408-G7111 | Janoshik | 2024-Q3 | 97.97 | 6.06 | 101.6 | Buyer-sourced | 0 | FAIL |
| AX-2024-005078 | SSA-2408-G7111 | Janoshik | 2024-Q3 | 97.96 | 6.57 | 90.8 | Buyer-sourced | 0 | FAIL |
| AX-2024-005079 | SSA-2408-G7111 | Kestrel | 2024-Q3 | 98.29 | 6.20 | 103.1 | Buyer-sourced | 0 | FAIL |
Cross-sections
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042222 | TFC | TFC-2607-R9099 | VendorInvestigate | 2026-Q3 | 99.46 | 5.41 | 102.6 | Buyer-sourced | 0 | PASS |
| AX-2026-042492 | Homopeptide | HOMO-2604-D5484 | Medutest | 2026-Q3 | 99.93 | 2.40 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042226 | TFC | TFC-2607-R9099 | Janoshik | 2026-Q3 | 99.62 | 5.47 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042491 | Homopeptide | HOMO-2604-D5484 | Kestrel | 2026-Q3 | 99.93 | 3.24 | — | Supplier-supplied | 0 | PASS |
| AX-2026-042495 | Homopeptide | HOMO-2604-D5484 | PeptideMeter | 2026-Q3 | 99.93 | 3.22 | 105.9 | Supplier-supplied | 0 | PASS |
| AX-2026-042220 | TFC | TFC-2607-R9099 | Janoshik | 2026-Q3 | 99.83 | 4.90 | 105.2 | Buyer-sourced | 0 | PASS |
| AX-2026-042344 | TFC | TFC-2604-Y3208 | Janoshik | 2026-Q3 | 99.68 | 3.43 | 95.9 | Buyer-sourced | 0 | PASS |
| AX-2026-042494 | Homopeptide | HOMO-2604-D5484 | Kestrel | 2026-Q3 | 99.93 | 2.69 | 96.0 | Buyer-sourced | 0 | PASS |
| Report | Compound | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043135 | BPC-157 | SSA-2601-N6863 | Nordanalyt | 2026-Q2 | 98.16 | 4.66 | 92.8 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043160 | GHK-Cu | SSA-2604-V7731 | Janoshik | 2026-Q2 | 98.01 | 4.02 | 91.8 | Buyer-sourced | 0 | PASS |
| AX-2026-043157 | GHK-Cu | SSA-2604-V7731 | Medutest | 2026-Q2 | 99.19 | 5.14 | — | Supplier-supplied | 0 | PASS |
| AX-2026-043141 | BPC-157 | SSA-2601-N6863 | Janoshik | 2026-Q2 | 98.06 | 4.06 | 94.6 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043154 | GHK-Cu | SSA-2604-V7731 | PeptideMeter | 2026-Q2 | 97.82 | 4.82 | 101.6 | Buyer-sourced | 0 | PASS |
| AX-2026-043137 | BPC-157 | SSA-2601-N6863 | PeptideMeter | 2026-Q2 | 98.17 | 4.14 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043162 | GHK-Cu | SSA-2604-V7731 | Janoshik | 2026-Q2 | 98.50 | 4.36 | — | Supplier-supplied | 0 | PASS |
| AX-2026-043134 | BPC-157 | SSA-2601-N6863 | Medutest | 2026-Q2 | 97.89 | 4.01 | — | Buyer-sourced | 1 | FAIL |