AX-2024-004349 · MOTS-c · FGP lot FGP-2411-A8499

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	99.81	% area	≥ 98.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.19	% area	≤ 2.0	PASS
Largest single impurity	RP-HPLC — bis-sulfoxide (+32 Da)	0.09	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	2173.0918	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, unit resolution (single quadrupole)	2173.0988	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+3.2	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	90.31	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	90.14	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	5.41	mg	5 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	4.877	mg	5 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	97.5	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	5.36	%	≤ 9.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	3.41	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.92	%	—	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	5.68	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 15 min gradient	5.78	min	5.63 ± 0.30 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.01	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	52,621	—	≥ 20,000	PASS
Resolution to nearest impurity	vs deamidated (+1 Da)	1.45	—	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 52,621, and skew follows the reported asymmetry factor of 1.01. 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 0.09 % impurity against a 99.81 % 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	MOTS-c — main peak	5.78	4,851,075	99.81	—
2	bis-sulfoxide (+32 Da)	5.45	4,374	0.09	+31.990
3	deamidated (+1 Da)	5.63	2,916	0.06	+0.984
4	Met1 sulfoxide (+16 Da)	5.59	1,944	0.04	+15.995
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 2173.0918 Da, computed from C101H152N28O22S2. 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 2173.0988 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+	544.2802	544.2820	0.0018	8.8
3+	725.3712	725.3735	0.0023	57.4
2+	1087.5532	1087.5567	0.0035	100.0
1+	2174.0991	2174.1061	0.0070	54.8

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	5.36
Counter-ion (acetate)	ion chromatography	3.41
Residual solvent + inorganic residue	estimated	0.92
Total peptide content	by difference	90.31
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)	99.62	99.81	divergence -0.19 pp vs batch median
Total impurities (% area)	0.38	0.19
Largest single impurity (% area)	not stated	0.09
Water (%)	4.8	5.36
Counter-ion (%)	not stated	3.41
Peptide content (%w/w)	not stated	90.31
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: Retail purchase → submitter (2–8 °C, 5 d) → laboratory (courier, ambient, 2 d) → assay.
Assay date: 29 Oct 2024
Submitted to the index: 22 Nov 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 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.

sig_figs22 Nov 2024

Two decimal places on 99.81 % implies repeatability better than 0.01 pp, which no laboratory here claims. The number is sound; the printed precision is more than the method carries.

Index data team

Two decimal places are retained because the source reports carry them and truncating would discard information where a laboratory genuinely reports it. The uncertainty budget on /methods/uncertainty-budget/ is the right thing to read alongside any purity figure on this site.

aib_coupling22 Nov 2024

Hindered couplings are where a synthesis loses purity, and the deletion products they leave are the first thing to look for. On this record they are not there in quantity.

esi_tof22 Nov 2024

Deconvolution over a full charge-state envelope with an internal calibrant is what makes +3.2 ppm mean something. All three conditions look satisfied on this record.

Section 7

Related records

Same batch — lot FGP-2411-A8499 n=5

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-018833	FGP-2411-A8499	Medutest	2024-Q4	99.73	5.10	—	Buyer-sourced	0	PASS
AX-2024-004350	FGP-2411-A8499	Janoshik	2024-Q4	99.73	5.10	—	Buyer-sourced	1	MARGINAL
AX-2024-004351	FGP-2411-A8499	Janoshik	2024-Q4	99.91	5.08	—	Buyer-sourced	0	PASS
AX-2024-004352	FGP-2411-A8499	Janoshik	2024-Q4	99.85	5.38	—	Buyer-sourced	0	PASS

Batch rollup and reproducibility assessment →

Cross-sections

Other recent MOTS-c records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042083	HYB	HYB-2606-D7858	Medutest	2026-Q3	99.93	2.02	—	Buyer-sourced	0	PASS
AX-2026-042090	HYB	HYB-2606-D7858	Janoshik	2026-Q3	99.57	2.36	—	Buyer-sourced	1	FAIL
AX-2026-042084	HYB	HYB-2606-D7858	Janoshik	2026-Q3	99.28	2.79	107.3	Buyer-sourced	0	PASS
AX-2026-042087	HYB	HYB-2606-D7858	Janoshik	2026-Q3	99.54	3.05	—	Buyer-sourced	0	PASS
AX-2026-042085	HYB	HYB-2606-D7858	Janoshik	2026-Q3	99.51	2.31	—	Buyer-sourced	0	PASS
AX-2026-042088	HYB	HYB-2606-D7858	PeptideMeter	2026-Q3	99.22	2.21	—	Buyer-sourced	0	PASS
AX-2026-042086	HYB	HYB-2606-D7858	Janoshik	2026-Q3	99.93	3.02	—	Buyer-sourced	1	MARGINAL
AX-2026-042081	HYB	HYB-2606-D7858	Nordanalyt	2026-Q3	99.68	3.31	96.5	Laboratory-retained	0	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