AX-2026-041672

SS-31 (Elamipretide) · 20 mg declared · Thermo Fisher Scientific (China) Co., Ltd. · lot TFS-{CAT}-9733

PASSPURITY ONLY

Report ID: AX-2026-041672
Compound: SS-31 (Elamipretide)
Compound class: Metabolic and mitochondrial peptides
Supplier: TFS — Thermo Fisher Scientific (China) Co., Ltd.
Batch / lot: TFS-{CAT}-9733
Declared label claim: 20mg
Laboratory: Janoshik Analytical
Assay date: 19 Jun 2026
Submitted: 09 Jul 2026
Quarter: 2026-Q2
Submitter: ms_confirm
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, 30 min gradient, 214 nm	99.71	% area	≥ 98.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.29	% area	≤ 1.5	PASS
Largest single impurity	RP-HPLC — C-terminal free acid (+1 Da)	0.12	% area	≤ 1.00	PASS
Identity	not ordered on this submission	not determined	—	required for VERIFIED status	NOT TESTED
Total peptide content	by difference from the gravimetric mass balance	87.68	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	87.43	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	23.49	mg	20 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	20.537	mg	20 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	102.7	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	4.63	%	≤ 9.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	7.34	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.35	%	—	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	3.99	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	9.10	min	8.94 ± 0.25 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.02	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	63,858	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [D-Arg1]-epimer	1.22	—	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 63,858, and skew follows the reported asymmetry factor of 1.02. 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 0.12 % impurity against a 99.71 % 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	9.10	4,846,215	99.71	—
2	C-terminal free acid (+1 Da)	9.30	5,832	0.12	+0.984
3	[D-Arg1]-epimer	8.92	3,402	0.07	0.000
4	des-Dmt (−193 Da)	8.38	3,402	0.07	-193.110
5	acetyl adduct (+42 Da)	9.64	1,458	0.03	+42.011
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	4.63
Counter-ion (acetate)	ion chromatography	7.34
Residual solvent + inorganic residue	estimated	0.35
Total peptide content	by difference	87.68
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)	99.30	99.71	divergence -0.31 pp vs batch median
Total impurities (% area)	0.70	0.29
Largest single impurity (% area)	0.24	0.12
Water (%)	3.7	4.63
Counter-ion (%)	not stated	7.34
Peptide content (%w/w)	not stated	87.68
Endotoxin (EU/mg)	3.79	not determined
Method stated on certificate	YES	—	column, gradient and wavelength given

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, 33 d) → laboratory (courier, cold pack, 12 d) → assay.
Assay date: 19 Jun 2026
Submitted to the index: 09 Jul 2026
Laboratory: Janoshik Analytical, Ostrava, Czechia
Method basis: 30 min gradient · high-resolution MS
Verification status: PURITY ONLY

What this report does not establish

That the compound is the compound named. No identity confirmation was ordered on this submission. A purity figure describes chromatographic homogeneity of whatever eluted; it does not name it.
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.

valley_drop09 Jul 2026

Largest single impurity is C-terminal free acid (+1 Da) at 0.12 % area, and it is the only named peak above 0.1 %. The integration is unambiguous and 99.71 % can be taken at face value.

lot_traceability09 Jul 2026

Lot TFS-{CAT}-9733 decodes to a manufacture date consistent with the custody chain above. Traceability plus 99.71 % is a complete story; either alone is half of one.

buyer_sourced09 Jul 2026

Provenance and purity together are what make a figure like this usable. An independently purchased vial at 99.71 % is worth several supplier-selected ones.

Section 7

Related records

Same batch — lot TFS-{CAT}-9733 n=2

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041673	TFS-{CAT}-9733	Janoshik	2026-Q2	99.51	5.34	100.9	Buyer-sourced	0	PASS

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 TFS records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041681	CJC-1295 with DAC	TFS-{CAT}-9675	PeptideMeter	2026-Q3	98.82	3.67	—	Buyer-sourced	0	PASS
AX-2026-041766	BPC-157	TFS-{CAT}-1156	Janoshik	2026-Q3	99.54	6.34	—	Buyer-sourced	1	MARGINAL
AX-2026-041682	CJC-1295 with DAC	TFS-{CAT}-9675	Nordanalyt	2026-Q3	98.94	3.24	—	Buyer-sourced	0	PASS
AX-2026-041683	CJC-1295 with DAC	TFS-{CAT}-9675	Medutest	2026-Q3	98.68	3.46	97.0	Buyer-sourced	0	PASS
AX-2026-041765	BPC-157	TFS-{CAT}-1156	Janoshik	2026-Q3	99.79	6.01	—	Buyer-sourced	0	PASS
AX-2026-041680	CJC-1295 with DAC	TFS-{CAT}-9675	Medutest	2026-Q3	99.18	2.85	100.4	Buyer-sourced	0	PASS
AX-2026-041691	Semaglutide	TFS-{CAT}-9744	Janoshik	2026-Q2	98.31	6.07	91.4	Buyer-sourced	0	PASS
AX-2026-041700	SS-31 (Elamipretide)	TFS-{CAT}-1142	Medutest	2026-Q2	99.75	2.27	96.3	Buyer-sourced	0	PASS