AX-2024-004636 · AOD-9604 · TFC lot TFC-2402-L2242

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, 15 min gradient, 214 nm	99.77	% area	≥ 98.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.23	% area	≤ 2.0	PASS
Largest single impurity	RP-HPLC — AOD dimer	0.14	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	1815.8672	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, unit resolution (single quadrupole)	1815.8716	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+2.4	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	89.38	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	89.17	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	9.95	mg	10 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	8.872	mg	10 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	88.7	%	90.0 – 110.0	FAIL
Water content	Karl Fischer, coulometric, duplicate	5.69	%	≤ 9.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	4.78	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.15	%	—	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	5.30	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 15 min gradient	6.06	min	6.09 ± 0.30 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	0.92	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	54,771	—	≥ 20,000	PASS
Resolution to nearest impurity	vs open-chain (reduced disulfide, +2 Da)	2.87	—	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, 15 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 54,771, and skew follows the reported asymmetry factor of 0.92. 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 0.14 % impurity against a 99.77 % 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	AOD-9604 — main peak	6.06	4,849,131	99.77	—
2	AOD dimer	7.11	6,804	0.14	+1813.852
3	des-Tyr AOD (−163 Da)	5.64	2,430	0.05	-163.063
4	open-chain (reduced disulfide, +2 Da)	5.75	1,944	0.04	+2.016
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 1815.8672 Da, computed from C78H123N23O23S2. All ppm figures on this site are against monoisotopic values — see why that matters.

Figure 2. ESI charge-state envelope, unit-resolution instrument. Sticks are placed at m/z = (M + z × 1.007276)/z for the observed neutral mass of 1815.8716 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 (%)
4+	454.9741	454.9752	0.0011	8.4
3+	606.2963	606.2978	0.0015	56.9
2+	908.9409	908.9431	0.0022	100.0
1+	1816.8745	1816.8789	0.0044	50.2

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	5.69
Counter-ion (acetate)	ion chromatography	4.78
Residual solvent + inorganic residue	estimated	0.15
Total peptide content	by difference	89.38
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)	98.77	99.77	divergence -0.42 pp vs batch median
Total impurities (% area)	1.23	0.23
Largest single impurity (% area)	0.47	0.14
Water (%)	3.2	5.69
Counter-ion (%)	4.9	4.78
Peptide content (%w/w)	91.3	89.38
Endotoxin (EU/mg)	0.20	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: Retail purchase → submitter (ambient, 20 d) → laboratory (courier, cold pack, 2 d) → assay.
Assay date: 24 Jun 2024
Submitted to the index: 20 Jul 2024
Laboratory: Kestrel Bioanalytical, Melbourne, Australia
Method basis: 15 min gradient · unit-resolution MS
Verification status: IDENTITY CONSISTENT

What this report does not establish

That the compound is not a near-isobaric alternative. Identity was confirmed at unit mass resolution, which cannot exclude species differing by 1 or 2 Da. The specific alternatives not excluded are named in the identity block above.
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.

ms_confirm20 Jul 2024

+2.4 ppm at this mass is a clean identity confirmation. With retention at 6.06 min, AOD-9604 is established as the species measured. Note what it does not exclude: a mass-identical diastereomer, which no mass measurement of any resolution can.

tbu_residual20 Jul 2024

No +56 Da satellite in the envelope, which is the residual-protection signature. Its absence is worth as much as the parent mass being right.

charge_envelope20 Jul 2024

Base peak lands where the charge-state arithmetic says it should for a species of this mass. That agreement is a check on the deconvolution rather than on the material, and it passes.

Section 7

Related records

Same batch — lot TFC-2402-L2242 n=5

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2024-004634	TFC-2402-L2242	Janoshik	2024-Q2	99.11	5.36	—	Buyer-sourced	0	PASS
AX-2024-004635	TFC-2402-L2242	Janoshik	2024-Q2	99.27	5.62	—	Buyer-sourced	0	PASS
AX-2024-004637	TFC-2402-L2242	Janoshik	2024-Q2	99.19	5.09	—	Buyer-sourced	1	MARGINAL
AX-2024-004638	TFC-2402-L2242	VendorInvestigate	2024-Q2	99.19	5.89	100.1	Buyer-sourced	0	PASS

Batch rollup and reproducibility assessment →

Cross-sections

Other recent AOD-9604 records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2026-043668	PPG	PPG-2602-W8018	PeptideMeter	2026-Q2	99.47	3.06	—	Buyer-sourced	PASS
AX-2026-043670	PPG	PPG-2602-W8018	PeptideMeter	2026-Q2	99.56	2.71	104.5	Buyer-sourced	PASS
AX-2026-042545	HJ	HJ-2601-N5554	Nordanalyt	2026-Q2	98.84	5.56	90.8	Buyer-sourced	PASS
AX-2026-042540	HJ	HJ-2601-N5554	Janoshik	2026-Q2	99.08	5.58	93.6	Buyer-sourced	PASS
AX-2026-043669	PPG	PPG-2602-W8018	Janoshik	2026-Q2	99.63	2.43	97.0	Buyer-sourced	PASS
AX-2026-043671	PPG	PPG-2602-W8018	PeptideMeter	2026-Q2	98.75	2.10	93.4	Buyer-sourced	PASS
AX-2026-042544	HJ	HJ-2601-N5554	Janoshik	2026-Q2	99.36	5.12	93.2	Supplier-supplied	PASS
AX-2026-042543	HJ	HJ-2601-N5554	PeptideMeter	2026-Q2	98.93	5.67	104.5	Laboratory-retained	PASS

Other recent TFC records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042265	Humanin (HNG)	TFC-2605-U1300	PeptideMeter	2026-Q3	99.52	6.31	—	Buyer-sourced	0	PASS
AX-2026-042222	SS-31 (Elamipretide)	TFC-2607-R9099	VendorInvestigate	2026-Q3	99.46	5.41	102.6	Buyer-sourced	0	PASS
AX-2026-042236	Humanin (HNG)	TFC-2608-S9940	Nordanalyt	2026-Q3	98.64	1.80	—	Buyer-sourced	0	PASS
AX-2026-042282	Retatrutide	TFC-2608-J1156	Janoshik	2026-Q3	98.54	4.27	—	Buyer-sourced	0	PASS
AX-2026-042226	SS-31 (Elamipretide)	TFC-2607-R9099	Janoshik	2026-Q3	99.62	5.47	—	Buyer-sourced	0	PASS
AX-2026-042217	Semaglutide	TFC-2604-X9037	PeptideMeter	2026-Q3	98.95	4.61	96.9	Buyer-sourced	0	PASS
AX-2026-042339	Sermorelin	TFC-2605-Y2176	Kestrel	2026-Q3	99.93	4.14	—	Supplier-supplied	1	FAIL
AX-2026-042214	Semaglutide	TFC-2604-X9037	Kestrel	2026-Q3	99.87	4.66	103.1	Laboratory-retained	0	PASS