AX-2025-020518

MOTS-c · 10 mg declared · Shanghai Sigma-Audley New Material Technology Co., Ltd. · lot SSA-2501-M6154

FAILPURITY ONLY

Report ID: AX-2025-020518
Compound: MOTS-c
Compound class: Metabolic and mitochondrial peptides
Supplier: SSA — Shanghai Sigma-Audley New Material Technology Co., Ltd.
Batch / lot: SSA-2501-M6154
Declared label claim: 10mg
Laboratory: Nordanalyt Laboratories
Assay date: 21 Feb 2025
Submitted: 02 Mar 2025
Quarter: 2025-Q1
Submitter: n.brandt
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, 35 min gradient, 214 nm	97.95	% area	≥ 98.0	FAIL
Total impurities	RP-HPLC, sum of reported peaks	2.05	% area	≤ 2.0	FAIL
Largest single impurity	RP-HPLC — bis-sulfoxide (+32 Da)	1.41	% area	≤ 1.00	FAIL
Identity	not ordered on this submission	not determined	—	required for VERIFIED status	NOT TESTED
Total peptide content	by difference from the gravimetric mass balance	90.72	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	88.86	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	11.73	mg	10 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	10.423	mg	10 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	104.2	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	2.77	%	≤ 9.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	5.52	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.99	%	—	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	Off-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	5.09	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 35 min gradient	11.95	min	12.02 ± 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	48,354	—	≥ 20,000	PASS
Resolution to nearest impurity	vs des-Met1 (−131 Da)	1.15	—	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, 35 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 48,354, 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 1.41 % impurity against a 97.95 % 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	11.95	4,760,674	97.95	—
2	bis-sulfoxide (+32 Da)	11.18	68,530	1.41	+31.990
3	deamidated (+1 Da)	11.60	12,637	0.26	+0.984
4	Met1 sulfoxide (+16 Da)	11.51	9,721	0.20	+15.995
5	des-Met1 (−131 Da)	12.21	8,749	0.18	-131.040
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	2.77
Counter-ion (acetate)	ion chromatography	5.52
Residual solvent + inorganic residue	estimated	0.99
Total peptide content	by difference	90.72
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)	98.78	97.95	divergence +0.68 pp vs batch median
Total impurities (% area)	1.22	2.05
Largest single impurity (% area)	not stated	1.41
Water (%)	0.8	2.77
Counter-ion (%)	not stated	5.52
Peptide content (%w/w)	94.4	90.72
Endotoxin (EU/mg)	0.24	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 (−20 °C, 14 d) → laboratory (courier, dry ice, 7 d) → assay.
Assay date: 21 Feb 2025
Submitted to the index: 02 Mar 2025
Laboratory: Nordanalyt Laboratories, Uppsala, Sweden
Method basis: 35 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 2

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.

hplc_ola02 Mar 2025

A longer gradient buys resolution on close-eluting pairs at a linear cost in run time. Nordanalyt ran 35 min here; the reference method runs 30, and the difference is visible in this figure.

plate_count02 Mar 2025

Flow rate is the free variable most operators never touch. Halving it on an isocratic hold across the pair is a fifteen-minute experiment with a definitive answer.

Section 7

Related records

Same batch — lot SSA-2501-M6154 n=12

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2025-020507	SSA-2501-M6154	Janoshik	2025-Q1	97.87	2.48	—	Buyer-sourced	FAIL
AX-2025-020508	SSA-2501-M6154	Medutest	2025-Q1	98.30	3.10	97.1	Supplier-supplied	PASS
AX-2025-020509	SSA-2501-M6154	Janoshik	2025-Q1	98.10	2.53	102.8	Buyer-sourced	PASS
AX-2025-020510	SSA-2501-M6154	Janoshik	2025-Q1	97.95	2.66	106.3	Buyer-sourced	FAIL
AX-2025-020511	SSA-2501-M6154	Nordanalyt	2025-Q1	98.11	2.87	—	Buyer-sourced	PASS
AX-2025-020512	SSA-2501-M6154	VendorInvestigate	2025-Q1	97.92	3.08	100.6	Buyer-sourced	FAIL
AX-2025-020513	SSA-2501-M6154	Medutest	2025-Q1	98.81	2.96	—	Supplier-supplied	PASS
AX-2025-020514	SSA-2501-M6154	Janoshik	2025-Q1	97.91	3.01	95.9	Buyer-sourced	FAIL
AX-2025-020515	SSA-2501-M6154	PeptideMeter	2025-Q1	98.24	3.07	—	Buyer-sourced	PASS
AX-2025-020516	SSA-2501-M6154	PeptideMeter	2025-Q1	98.70	2.52	90.2	Supplier-supplied	PASS
AX-2025-020517	SSA-2501-M6154	VendorInvestigate	2025-Q1	98.21	3.21	103.0	Buyer-sourced	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 SSA records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043135	BPC-157	SSA-2601-N6863	Nordanalyt	2026-Q2	98.16	4.66	92.8	Buyer-sourced	1	MARGINAL
AX-2026-043160	GHK-Cu	SSA-2604-V7731	Janoshik	2026-Q2	98.01	4.02	91.8	Buyer-sourced	0	PASS
AX-2026-043157	GHK-Cu	SSA-2604-V7731	Medutest	2026-Q2	99.19	5.14	—	Supplier-supplied	0	PASS
AX-2026-043141	BPC-157	SSA-2601-N6863	Janoshik	2026-Q2	98.06	4.06	94.6	Buyer-sourced	1	MARGINAL
AX-2026-043154	GHK-Cu	SSA-2604-V7731	PeptideMeter	2026-Q2	97.82	4.82	101.6	Buyer-sourced	0	PASS
AX-2026-043137	BPC-157	SSA-2601-N6863	PeptideMeter	2026-Q2	98.17	4.14	—	Buyer-sourced	1	MARGINAL
AX-2026-043162	GHK-Cu	SSA-2604-V7731	Janoshik	2026-Q2	98.50	4.36	—	Supplier-supplied	0	PASS
AX-2026-043134	BPC-157	SSA-2601-N6863	Medutest	2026-Q2	97.89	4.01	—	Buyer-sourced	1	FAIL