AX-2026-042261 · KPV · TFC lot TFC-2508-M9624

Section 1

Results

Measured against the index acceptance specification for the tissue-repair and immunomodulatory 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, 25 min gradient, 214 nm	99.93	% area	≥ 99.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.07	% area	≤ 1.0	PASS
Largest single impurity	RP-HPLC — acetyl-KPV (+42 Da)	0.04	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	342.2267	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, unit resolution (single quadrupole)	342.2277	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+2.9	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	82.55	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	82.49	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	23.55	mg	20 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	19.426	mg	20 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	97.1	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	3.20	%	≤ 10.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	13.83	%	≤ 12.0	FAIL
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.42	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	0.32	EU/mg	≤ 5.0	PASS
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	4.88	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 25 min gradient	4.51	min	4.44 ± 0.20 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	0.96	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	72,722	—	≥ 20,000	PASS
Resolution to nearest impurity	vs diketopiperazine (−18 Da)	1.82	—	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, 25 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 72,722, and skew follows the reported asymmetry factor of 0.96. 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 0.04 % impurity against a 99.93 % 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	KPV — main peak	4.51	4,856,908	99.93	—
2	acetyl-KPV (+42 Da)	4.76	1,944	0.04	+42.011
3	diketopiperazine (−18 Da)	4.63	1,458	0.03	-18.011
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 342.2267 Da, computed from C16H30N4O4. 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 342.2277 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 (%)
1+	343.2340	343.2350	0.0010	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.

Component	Determination	%w/w of cake
Water	Karl Fischer	3.20
Counter-ion (acetate)	ion chromatography	13.83
Residual solvent + inorganic residue	estimated	0.42
Total peptide content	by difference	82.55
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)	99.90	99.93	divergence -0.03 pp vs batch median
Total impurities (% area)	0.10	0.07
Largest single impurity (% area)	not stated	0.04
Water (%)	2.6	3.20
Counter-ion (%)	not stated	13.83
Peptide content (%w/w)	not stated	82.55
Endotoxin (EU/mg)	not stated	0.32
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, 9 d) → laboratory (courier, dry ice, 4 d) → assay.
Assay date: 21 Jan 2026
Submitted to the index: 11 Feb 2026
Laboratory: Medutest, Ljubljana, Slovenia
Method basis: 25 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 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.

c18_2p611 Feb 2026

Column chemistry flatters or punishes a figure like this. A core-shell column at this gradient resolves the close-eluting family that a fully porous 5 µm bed merges, so 99.93 % here is a harder number than the same figure from a coarser column.

quarter_over_quarter11 Feb 2026

Single records do not establish trends. Where this supplier's quarterly medians are stable across four quarters, a result like this reads as the process rather than the draw — and the timeline page is where to check that.

esi_tof11 Feb 2026

Identity confirmed and purity at 99.93 %. The two answer different questions — what it is, and how much else is in it — and a record carrying both is the version worth citing.

survodutide_mixup11 Feb 2026

Where two compounds elute within a third of a minute, a mass at this accuracy is what separates them. Retention alone would not have.

Section 7

Related records

Same batch — lot TFC-2508-M9624 n=7

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042257	TFC-2508-M9624	Janoshik	2026-Q1	99.54	2.81	95.6	Buyer-sourced	0	FAIL
AX-2026-042258	TFC-2508-M9624	Janoshik	2026-Q1	99.60	2.58	93.1	Buyer-sourced	0	PASS
AX-2026-042259	TFC-2508-M9624	Janoshik	2026-Q1	99.93	3.38	89.4	Buyer-sourced	1	FAIL
AX-2026-042260	TFC-2508-M9624	PeptideMeter	2026-Q1	99.93	2.89	99.2	Buyer-sourced	0	FAIL
AX-2026-042262	TFC-2508-M9624	Janoshik	2026-Q1	99.89	3.32	92.2	Buyer-sourced	0	FAIL
AX-2026-042263	TFC-2508-M9624	Kestrel	2026-Q1	99.93	2.93	—	Buyer-sourced	0	FAIL

Batch rollup and reproducibility assessment →

Cross-sections

Other recent KPV records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042742	GGPeps	GGPE-2511-K1569	Janoshik	2026-Q2	98.40	5.09	—	Buyer-sourced	0	FAIL
AX-2026-042259	TFC	TFC-2508-M9624	Janoshik	2026-Q1	99.93	3.38	89.4	Buyer-sourced	1	FAIL
AX-2026-042078	HYB	HYB-2511-P7317	Nordanalyt	2026-Q1	99.59	3.92	98.8	Buyer-sourced	0	PASS
AX-2026-042262	TFC	TFC-2508-M9624	Janoshik	2026-Q1	99.89	3.32	92.2	Buyer-sourced	0	FAIL
AX-2026-042260	TFC	TFC-2508-M9624	PeptideMeter	2026-Q1	99.93	2.89	99.2	Buyer-sourced	0	FAIL
AX-2026-042079	HYB	HYB-2511-P7317	Janoshik	2026-Q1	99.68	5.67	94.7	Buyer-sourced	0	FAIL
AX-2026-042257	TFC	TFC-2508-M9624	Janoshik	2026-Q1	99.54	2.81	95.6	Buyer-sourced	0	FAIL
AX-2026-042258	TFC	TFC-2508-M9624	Janoshik	2026-Q1	99.60	2.58	93.1	Buyer-sourced	0	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