AX-2026-041645

SS-31 (Elamipretide) · 20 mg declared · Flourishglobal Peptide Biotech (Chengdu) Co., Ltd. · lot FGP-2601-R8955

FAILIDENTITY CONSISTENT

Report ID: AX-2026-041645
Compound: SS-31 (Elamipretide)
Compound class: Metabolic and mitochondrial peptides
Supplier: FGP — Flourishglobal Peptide Biotech (Chengdu) Co., Ltd.
Batch / lot: FGP-2601-R8955
Declared label claim: 20mg
Laboratory: Janoshik Analytical
Assay date: 15 Jun 2026
Submitted: 25 Jun 2026
Quarter: 2026-Q2
Submitter: ne.achebe
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	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 — acetyl adduct (+42 Da)	0.89	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	639.3856	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, high resolution (ESI-TOF/QTOF)	639.3617	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	-37.4	ppm	± 15	FAIL
Peptide content	not ordered on this submission	not determined	—	required to check label claim	NOT TESTED
Water content	Karl Fischer, coulometric, duplicate	4.05	%	≤ 9.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	9.56	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.46	%	—	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	5.12	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	8.77	min	8.94 ± 0.25 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	0.87	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	59,305	—	≥ 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 59,305, and skew follows the reported asymmetry factor of 0.87. 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 0.89 % impurity against a 97.83 % 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	8.77	4,754,841	97.83	—
2	acetyl adduct (+42 Da)	9.31	43,257	0.89	+42.011
3	C-terminal free acid (+1 Da)	8.97	34,022	0.70	+0.984
4	des-Dmt (−193 Da)	8.05	17,011	0.35	-193.110
5	[D-Arg1]-epimer	8.59	11,179	0.23	0.000
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 639.3617 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	320.6881	-0.0120	50.1
1+	640.3929	640.3690	-0.0239	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.

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)	97.74	97.83	divergence -0.70 pp vs batch median
Total impurities (% area)	2.26	2.17
Largest single impurity (% area)	not stated	0.89
Water (%)	2.5	4.05
Counter-ion (%)	not stated	9.56
Peptide content (%w/w)	not stated	not determined
Endotoxin (EU/mg)	0.22	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: Retail purchase → submitter (ambient, 8 d) → laboratory (courier, cold pack, 12 d) → assay.
Assay date: 15 Jun 2026
Submitted to the index: 25 Jun 2026
Laboratory: Janoshik Analytical, Ostrava, Czechia
Method basis: 30 min gradient · high-resolution MS
Verification status: IDENTITY CONSISTENT

What this report does not establish

How much of the named compound is in the vial. Peptide content was not determined, so recovered mass cannot be calculated and the label claim cannot be checked.
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 4

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_watcher25 Jun 2026

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.

pt141_one_da25 Jun 2026

On compounds with a one-dalton neighbour, a mass error of this size is genuinely consequential and not merely untidy. This is not one of the ambiguous pairs, but the principle is why the index caps status rather than passing the record.

ms_confirm25 Jun 2026

Identity confirmation needs a reference standard and the record does not say whose was used. Where the deviation is small this is the first ambiguity to remove.

buyer_sourced25 Jun 2026

Buyer-sourced through an ordinary retail order, so the supplier had no opportunity to select the vial. This is the provenance class the index weights and it is roughly 87 % of the dataset.

Section 7

Related records

Same batch — lot FGP-2601-R8955 n=5

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041646	FGP-2601-R8955	Janoshik	2026-Q2	98.27	3.45	90.7	Buyer-sourced	1	FAIL
AX-2026-041647	FGP-2601-R8955	Janoshik	2026-Q2	98.44	4.08	90.9	Buyer-sourced	1	FAIL
AX-2026-041648	FGP-2601-R8955	Janoshik	2026-Q2	98.45	3.95	—	Buyer-sourced	1	FAIL
AX-2026-041649	FGP-2601-R8955	Janoshik	2026-Q2	98.53	4.12	103.8	Buyer-sourced	1	MARGINAL

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 FGP records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2026-041643	Semaglutide	FGP-2602-M8547	Janoshik	2026-Q3	99.31	2.79	100.7	Buyer-sourced	PASS
AX-2026-041638	Semaglutide	FGP-2602-M8547	Janoshik	2026-Q3	99.40	2.75	105.8	Buyer-sourced	PASS
AX-2026-041641	Semaglutide	FGP-2602-M8547	PeptideMeter	2026-Q3	98.98	2.38	105.0	Buyer-sourced	PASS
AX-2026-041610	Tirzepatide	FGP-2603-L7753	Janoshik	2026-Q3	98.81	2.45	101.0	Buyer-sourced	PASS
AX-2026-041637	Semaglutide	FGP-2602-M8547	PeptideMeter	2026-Q3	99.40	2.83	—	Laboratory-retained	PASS
AX-2026-041642	Semaglutide	FGP-2602-M8547	PeptideMeter	2026-Q3	98.78	2.24	—	Buyer-sourced	PASS
AX-2026-041609	Tirzepatide	FGP-2603-L7753	Janoshik	2026-Q3	98.52	2.00	98.0	Buyer-sourced	PASS
AX-2026-041636	Semaglutide	FGP-2602-M8547	Nordanalyt	2026-Q3	99.39	2.17	—	Buyer-sourced	PASS