AX-2025-020425 · KPV · MKM lot MKM-2504-N4868

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, 30 min gradient, 214 nm	99.68	% area	≥ 99.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.32	% area	≤ 1.0	PASS
Largest single impurity	RP-HPLC — Lys-Pro dipeptide (−99 Da)	0.18	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	342.2267	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, high resolution (ESI-TOF/QTOF)	342.2280	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+3.9	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	79.82	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	79.56	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	6.64	mg	5 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	5.283	mg	5 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	105.7	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	5.77	%	≤ 10.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	14.25	%	≤ 12.0	FAIL
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.16	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	0.30	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	6.17	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	5.19	min	5.24 ± 0.20 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.23	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	46,773	—	≥ 20,000	PASS
Resolution to nearest impurity	vs diketopiperazine (−18 Da)	1.52	—	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, 30 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 46,773, and skew follows the reported asymmetry factor of 1.23. 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 0.18 % impurity against a 99.68 % 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	5.19	4,844,757	99.68	—
2	Lys-Pro dipeptide (−99 Da)	4.83	8,749	0.18	-99.068
3	Pro-Val dipeptide (−128 Da)	4.75	3,888	0.08	-128.095
4	acetyl-KPV (+42 Da)	5.49	1,458	0.03	+42.011
5	diketopiperazine (−18 Da)	5.34	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, high-resolution instrument. Sticks are placed at m/z = (M + z × 1.007276)/z for the observed neutral mass of 342.2280 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	343.2353	0.0013	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	5.77
Counter-ion (acetate)	ion chromatography	14.25
Residual solvent + inorganic residue	estimated	0.16
Total peptide content	by difference	79.82
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)	99.10	99.68	divergence -0.80 pp vs batch median
Total impurities (% area)	0.90	0.32
Largest single impurity (% area)	0.44	0.18
Water (%)	not stated	5.77
Counter-ion (%)	not stated	14.25
Peptide content (%w/w)	not stated	79.82
Endotoxin (EU/mg)	not stated	0.30
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, 18 d) → laboratory (courier, ambient, 10 d) → assay.
Assay date: 05 May 2025
Submitted to the index: 30 May 2025
Laboratory: Janoshik Analytical, Ostrava, Czechia
Method basis: 30 min gradient · high-resolution MS
Verification status: VERIFIED

What this report does not establish

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.

esi_tof30 May 2025

Mass, retention and impurity profile all agree on this record. Three independent constraints pointing the same way is the strongest identity evidence the index publishes.

ms_confirm30 May 2025

An orthogonal identity method on the same lot would make this the strongest class of record the index holds. Mass plus retention is already better than most.

label_claim30 May 2025

A retail vial is also a test of the label. Declared claim 5 mg against what the gravimetry recovers is a question only a purchased vial can answer honestly.

peak_integrator30 May 2025

Two laboratories with different gradients will resolve a close pair differently and report two honest, different purities. Neither is wrong and the difference is not a disagreement about the material.

Section 7

Related records

Same batch — lot MKM-2504-N4868 n=12

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-020420	MKM-2504-N4868	Janoshik	2025-Q2	99.66	5.08	93.8	Buyer-sourced	0	FAIL
AX-2025-020421	MKM-2504-N4868	Medutest	2025-Q2	99.93	4.41	89.0	Supplier-supplied	1	FAIL
AX-2025-020422	MKM-2504-N4868	Medutest	2025-Q2	99.93	5.28	—	Laboratory-retained	0	FAIL
AX-2025-020423	MKM-2504-N4868	Janoshik	2025-Q2	99.43	5.57	102.2	Buyer-sourced	0	PASS
AX-2025-020424	MKM-2504-N4868	PeptideMeter	2025-Q2	99.93	5.47	—	Buyer-sourced	0	PASS
AX-2025-020426	MKM-2504-N4868	Medutest	2025-Q2	99.93	5.62	97.9	Buyer-sourced	1	FAIL
AX-2025-020427	MKM-2504-N4868	Kestrel	2025-Q2	99.93	5.15	95.4	Buyer-sourced	0	FAIL
AX-2025-020428	MKM-2504-N4868	Nordanalyt	2025-Q2	99.93	6.09	—	Buyer-sourced	0	FAIL
AX-2025-020429	MKM-2504-N4868	PeptideMeter	2025-Q2	99.87	5.26	—	Buyer-sourced	0	PASS
AX-2025-020430	MKM-2504-N4868	PeptideMeter	2025-Q2	99.72	5.44	—	Buyer-sourced	0	PASS
AX-2025-020431	MKM-2504-N4868	PeptideMeter	2025-Q2	99.76	5.50	—	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-2026-042261	TFC	TFC-2508-M9624	Medutest	2026-Q1	99.93	3.20	97.1	Buyer-sourced	0	FAIL

Other recent MKM records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2026-042942	CJC-1295 (no DAC)	MKM-2603-V3346	Janoshik	2026-Q3	99.52	3.43	—	Supplier-supplied	PASS
AX-2026-043019	Adipotide	MKM-2606-K5012	Janoshik	2026-Q3	97.61	5.77	105.1	Buyer-sourced	PASS
AX-2026-042939	CJC-1295 (no DAC)	MKM-2603-V3346	PeptideMeter	2026-Q3	99.44	3.39	—	Buyer-sourced	PASS
AX-2026-043020	Adipotide	MKM-2606-K5012	Medutest	2026-Q3	97.73	5.74	—	Buyer-sourced	PASS
AX-2026-043022	Adipotide	MKM-2606-K5012	Kestrel	2026-Q3	97.69	6.33	106.9	Buyer-sourced	PASS
AX-2026-043023	Adipotide	MKM-2606-K5012	Medutest	2026-Q3	97.48	5.56	103.7	Supplier-supplied	PASS
AX-2026-042945	CJC-1295 (no DAC)	MKM-2603-V3346	PeptideMeter	2026-Q3	99.39	3.54	—	Laboratory-retained	PASS
AX-2026-042938	CJC-1295 (no DAC)	MKM-2603-V3346	Nordanalyt	2026-Q3	99.47	3.67	95.0	Buyer-sourced	PASS