AX-2025-020995

SS-31 (Elamipretide) · 10 mg declared · Chinese Peptide Company Co., Ltd. · lot CPC-2508-F3666

FAILIDENTITY CONSISTENT

Report ID: AX-2025-020995
Compound: SS-31 (Elamipretide)
Compound class: Metabolic and mitochondrial peptides
Supplier: CPC — Chinese Peptide Company Co., Ltd.
Batch / lot: CPC-2508-F3666
Declared label claim: 10mg
Laboratory: PeptideMeter
Assay date: 28 Jul 2025
Submitted: 15 Aug 2025
Quarter: 2025-Q3
Submitter: ka.castellanos
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	97.87	% area	≥ 98.5	FAIL
Total impurities	RP-HPLC, sum of reported peaks	2.13	% area	≤ 1.5	FAIL
Largest single impurity	RP-HPLC — [D-Arg1]-epimer	0.82	% 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)	639.3868	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+1.8	ppm	± 15	PASS
Peptide content	not ordered on this submission	not determined	—	required to check label claim	NOT TESTED
Water content	Karl Fischer, coulometric, duplicate	3.58	%	≤ 9.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	6.52	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.32	%	—	NOT TESTED
Endotoxin	not ordered on this submission	not determined	—	≤ 5.0	NOT TESTED
Sterility	membrane filtration, USP <71>, 14 d	No growth at 14 d	—	no growth	PASS
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 after 90 s gentle swirling, no particulates	—	clear, no visible particulates	PASS
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	4.98	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 28 min gradient	8.55	min	8.39 ± 0.25 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.13	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	62,073	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [D-Arg1]-epimer	1.19	—	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, 28 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 62,073, and skew follows the reported asymmetry factor of 1.13. 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 0.82 % impurity against a 97.87 % 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	8.55	4,756,785	97.87	—
2	[D-Arg1]-epimer	8.38	39,855	0.82	0.000
3	C-terminal free acid (+1 Da)	8.74	29,648	0.61	+0.984
4	acetyl adduct (+42 Da)	9.05	17,983	0.37	+42.011
5	des-Dmt (−193 Da)	7.88	16,039	0.33	-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 639.3868 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	320.7007	0.0006	56.8
1+	640.3929	640.3941	0.0012	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)	99.0	97.87	divergence +1.13 pp vs batch median
Total impurities (% area)	not stated	2.13
Largest single impurity (% area)	not stated	0.82
Water (%)	not stated	3.58
Counter-ion (%)	not stated	6.52
Peptide content (%w/w)	not stated	not determined
Endotoxin (EU/mg)	not stated	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 (2–8 °C, 9 d) → laboratory (courier, ambient, 10 d) → assay.
Assay date: 28 Jul 2025
Submitted to the index: 15 Aug 2025
Laboratory: PeptideMeter, Tallinn, Estonia
Method basis: 28 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 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

No annotations on this record. Annotations are short signed technical comments from index contributors; see how to contribute.

Section 7

Related records

Same batch — lot CPC-2508-F3666 n=1

This is the only report on this lot. One report is not a batch characterisation.

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	Flags	Result
AX-2026-042067	TFC	TFC-2604-Y7472	Kestrel	2026-Q3	98.66	4.44	—	Supplier-supplied	1	MARGINAL
AX-2026-042068	TFC	TFC-2604-Y7472	Medutest	2026-Q3	98.71	3.63	92.9	Supplier-supplied	2	MARGINAL
AX-2026-042069	TFC	TFC-2604-Y7472	Janoshik	2026-Q3	98.16	3.65	—	Supplier-supplied	2	FAIL
AX-2026-042070	TFC	TFC-2604-Y7472	PeptideMeter	2026-Q3	98.09	3.60	97.9	Supplier-supplied	1	FAIL
AX-2026-042072	TFC	TFC-2604-Y7472	VendorInvestigate	2026-Q3	97.88	3.47	89.5	Buyer-sourced	2	FAIL
AX-2026-042236	Homopeptide	HOMO-2604-D1599	PeptideMeter	2026-Q3	99.61	2.79	—	Supplier-supplied	0	PASS
AX-2026-041951	TFC	TFC-2607-R4363	Medutest	2026-Q3	99.56	5.16	—	Buyer-sourced	0	PASS
AX-2026-042071	TFC	TFC-2604-Y7472	PeptideMeter	2026-Q3	97.71	3.47	93.0	Laboratory-retained	2	FAIL

Other recent CPC records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043368	N-Acetyl Semax Amide	CPC-2602-D2941	Medutest	2026-Q3	98.79	6.05	102.1	Supplier-supplied	0	PASS
AX-2026-043335	Liraglutide	CPC-2602-G1978	Janoshik	2026-Q3	97.29	4.91	—	Laboratory-retained	1	FAIL
AX-2026-043283	L-Carnosine	CPC-2603-G1651	Medutest	2026-Q3	98.10	10.12	91.8	Supplier-supplied	1	FAIL
AX-2026-043365	BPC-157	CPC-2602-W2646	Medutest	2026-Q3	98.56	2.80	—	Supplier-supplied	1	MARGINAL
AX-2026-043332	Liraglutide	CPC-2602-G1978	Janoshik	2026-Q3	97.16	4.88	91.3	Supplier-supplied	1	FAIL
AX-2026-043289	L-Carnosine	CPC-2603-G1651	Janoshik	2026-Q3	98.01	10.52	—	Buyer-sourced	1	FAIL
AX-2026-043287	L-Carnosine	CPC-2603-G1651	Janoshik	2026-Q3	98.35	9.89	93.2	Supplier-supplied	2	FAIL
AX-2026-043367	N-Acetyl Semax Amide	CPC-2602-D2941	Nordanalyt	2026-Q3	99.39	6.16	92.4	Supplier-supplied	0	PASS