AX-2024-005072 · SS-31 (Elamipretide) · SSA lot SSA-2408-G7111

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, 30 min gradient, 214 nm	98.03	% area	≥ 98.5	FAIL
Total impurities	RP-HPLC, sum of reported peaks	1.97	% area	≤ 1.5	FAIL
Largest single impurity	RP-HPLC — [D-Arg1]-epimer	1.07	% area	≤ 1.00	FAIL
Identity — theoretical monoisotopic mass	calculated from molecular formula	639.3856	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, high resolution (ESI-TOF/QTOF)	639.3832	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	-3.7	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	84.83	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	83.16	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	11.97	mg	10 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	9.954	mg	10 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	99.5	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	6.58	%	≤ 9.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	8.12	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.47	%	—	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 with a single visible fibre	—	clear, no visible particulates	FAIL
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	4.45	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	8.88	min	8.94 ± 0.25 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	0.94	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	52,280	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [D-Arg1]-epimer	1.13	—	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.

Figure 1. RP-HPLC trace, 30 min gradient, 214 nm. Drawn from the peak-integration table below: peak positions are the reported retention times, peak areas are the reported area percentages, peak widths follow the reported plate count of 52,280, and skew follows the reported asymmetry factor of 0.94. Baseline noise is seeded from the report ID and is illustrative. The lower panel is the same trace at a stated vertical expansion with the slow gradient drift subtracted, because at full scale a 1.07 % impurity against a 98.03 % main peak is a line two pixels tall; the main peak runs off-scale there by design.

#	Peak	RT	Area (µV·s)	% area	Δ mass (Da)
1	SS-31 (Elamipretide) — main peak	8.88	4,764,562	98.03	—
2	[D-Arg1]-epimer	8.70	52,005	1.07	0.000
3	acetyl adduct (+42 Da)	9.42	29,162	0.60	+42.011
4	C-terminal free acid (+1 Da)	9.08	9,721	0.20	+0.984
5	des-Dmt (−193 Da)	8.16	4,860	0.10	-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 3

Mass spectrum and identity

Theoretical monoisotopic mass 639.3856 Da, computed from C32H49N9O5. All ppm figures on this site are against monoisotopic values — see why that matters.

Figure 2. ESI charge-state envelope, high-resolution instrument. Sticks are placed at m/z = (M + z × 1.007276)/z for the observed neutral mass of 639.3832 Da. Sodium (+21.982/z) and potassium (+37.956/z) adducts are shown where the parent charge state exceeds 25 % relative abundance; they are adducts of the same molecule and are not impurities.

Charge	Theoretical m/z	Observed m/z	Δ m/z	Rel. abundance (%)
2+	320.7001	320.6989	-0.0012	56.0
1+	640.3929	640.3905	-0.0024	100.0

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	6.58
Counter-ion (acetate)	ion chromatography	8.12
Residual solvent + inorganic residue	estimated	0.47
Total peptide content	by difference	84.83
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	98.03	divergence +0.44 pp vs batch median
Total impurities (% area)	1.59	1.97
Largest single impurity (% area)	not stated	1.07
Water (%)	5.2	6.58
Counter-ion (%)	not stated	8.12
Peptide content (%w/w)	not stated	84.83
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, 7 d) → laboratory (courier, cold pack, 7 d) → assay.
Assay date: 22 Sep 2024
Submitted to the index: 30 Sep 2024
Laboratory: Janoshik Analytical, Ostrava, Czechia
Method basis: 30 min gradient · high-resolution MS
Verification status: VERIFIED

What this report does not establish

That the material is free of bacterial endotoxin. Endotoxin was not measured. No chromatographic result bears on it.
That the material is sterile. Sterility was not tested.
That any other vial in the same lot has the same composition. One vial was tested. Within-lot vial-to-vial variation in this index has a median of 0.28 pp and a 90th percentile of 0.74 pp.
That any other lot from the same supplier has the same composition. Batch-to-batch variation is larger than within-batch variation for every supplier here.
That the material is suitable for administration to a human or an animal. These are research compounds. No result on this site is a safety assessment and the index takes no position on use.
That the material was manufactured by the supplier that sold it. Contract synthesis is normal in this market and twenty-nine batches in the index fingerprint to a bulk from a different company than the one named on the label.

Section 6

Annotations 3

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.

iqr_watcher30 Sep 2024

One low result does not characterise a supplier and one high one does not either. The question is whether this lot sits in the left tail of a tight distribution or in the middle of a wide one, and the scorecard's IQR answers it.

isotope_cluster30 Sep 2024

Nothing here rules out a positional isomer with the same formula. Mass cannot; only chromatography can, and the gradient length on this record is the relevant fact for that.

mass_defect30 Sep 2024

Identity confirmed, purity 98.03 %, mass balance closed. This record is complete against the index definition of complete and there is nothing outstanding on it.

Section 7

Related records

Same batch — lot SSA-2408-G7111 n=14

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2024-005066	SSA-2408-G7111	PeptideMeter	2024-Q3	97.83	5.73	93.3	Buyer-sourced	0	FAIL
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-2024-005073	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

Batch rollup and reproducibility assessment →

Cross-sections

Other recent SS-31 (Elamipretide) records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2026-042222	TFC	TFC-2607-R9099	VendorInvestigate	2026-Q3	99.46	5.41	102.6	Buyer-sourced	PASS
AX-2026-042492	Homopeptide	HOMO-2604-D5484	Medutest	2026-Q3	99.93	2.40	—	Buyer-sourced	PASS
AX-2026-042226	TFC	TFC-2607-R9099	Janoshik	2026-Q3	99.62	5.47	—	Buyer-sourced	PASS
AX-2026-042491	Homopeptide	HOMO-2604-D5484	Kestrel	2026-Q3	99.93	3.24	—	Supplier-supplied	PASS
AX-2026-042495	Homopeptide	HOMO-2604-D5484	PeptideMeter	2026-Q3	99.93	3.22	105.9	Supplier-supplied	PASS
AX-2026-042220	TFC	TFC-2607-R9099	Janoshik	2026-Q3	99.83	4.90	105.2	Buyer-sourced	PASS
AX-2026-042344	TFC	TFC-2604-Y3208	Janoshik	2026-Q3	99.68	3.43	95.9	Buyer-sourced	PASS
AX-2026-042494	Homopeptide	HOMO-2604-D5484	Kestrel	2026-Q3	99.93	2.69	96.0	Buyer-sourced	PASS

Other recent SSA records in the index.
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