AX-2025-020849 · KPV · CPC lot CPC-2502-M2176

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	98.49	% area	≥ 99.0	FAIL
Total impurities	RP-HPLC, sum of reported peaks	1.51	% area	≤ 1.0	FAIL
Largest single impurity	RP-HPLC — Lys-Pro dipeptide (−99 Da)	0.96	% 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)	342.2270	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+0.9	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	83.55	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	82.29	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	25.52	mg	20 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	21.000	mg	20 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	105.0	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	2.77	%	≤ 10.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	13.46	%	≤ 12.0	FAIL
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.22	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	0.94	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	5.04	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 25 min gradient	3.58	min	4.44 ± 0.20 (normalised)	FAIL
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	59,789	—	≥ 20,000	PASS
Resolution to nearest impurity	vs diketopiperazine (−18 Da)	2.08	—	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 59,789, 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 0.96 % impurity against a 98.49 % 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	3.58	4,786,919	98.49	—
2	Lys-Pro dipeptide (−99 Da)	3.28	46,659	0.96	-99.068
3	acetyl-KPV (+42 Da)	3.83	17,983	0.37	+42.011
4	Pro-Val dipeptide (−128 Da)	3.21	5,346	0.11	-128.095
5	diketopiperazine (−18 Da)	3.71	3,402	0.07	-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 342.2270 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	343.2343	0.0003	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	2.77
Counter-ion (acetate)	ion chromatography	13.46
Residual solvent + inorganic residue	estimated	0.22
Total peptide content	by difference	83.55
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)	98.44	98.49	divergence +0.13 pp vs batch median
Total impurities (% area)	not stated	1.51
Largest single impurity (% area)	not stated	0.96
Water (%)	2.3	2.77
Counter-ion (%)	not stated	13.46
Peptide content (%w/w)	not stated	83.55
Endotoxin (EU/mg)	not stated	0.94
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: Domestic warehouse despatch → submitter (2–8 °C, 4 d) → laboratory (courier, cold pack, 10 d) → assay.
Assay date: 13 Aug 2025
Submitted to the index: 04 Sep 2025
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.

gradient_2504 Sep 2025

Before treating 98.49 % as a process finding, check what it is being compared against. The index specification assumes the reference gradient; a figure taken on a different method is not automatically comparable to it.

spec_vs_result04 Sep 2025

The index specification is a threshold the index chose. A result below it is a measurement below a decision, not a regulatory status and not a safety statement. What it does establish is that this vial is not what the class specification describes.

lipidation_step04 Sep 2025

On an acylated compound the mono-ester by-product of the side-chain step is the impurity that most often carries a result into this band, and it is regiochemistry rather than sloppiness. The named table above will say whether that is what happened here.

nmr_qnmr04 Sep 2025

Mass at +0.9 ppm establishes identity but not content. Absolute content needs a standard or an orthogonal quantitative method, and neither is a mass spectrometer.

Section 7

Related records

Same batch — lot CPC-2502-M2176 n=11

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-020839	CPC-2502-M2176	Nordanalyt	2025-Q3	98.14	2.79	—	Buyer-sourced	0	FAIL
AX-2025-020840	CPC-2502-M2176	Janoshik	2025-Q3	98.19	3.10	—	Buyer-sourced	0	FAIL
AX-2025-020841	CPC-2502-M2176	Janoshik	2025-Q3	98.31	3.20	91.1	Buyer-sourced	0	FAIL
AX-2025-020842	CPC-2502-M2176	Medutest	2025-Q3	98.83	3.64	—	Supplier-supplied	1	FAIL
AX-2025-020843	CPC-2502-M2176	Janoshik	2025-Q3	98.08	3.15	—	Buyer-sourced	0	FAIL
AX-2025-020844	CPC-2502-M2176	Medutest	2025-Q3	98.60	3.40	—	Buyer-sourced	0	FAIL
AX-2025-020845	CPC-2502-M2176	VendorInvestigate	2025-Q3	98.58	3.63	—	Buyer-sourced	0	FAIL
AX-2025-020846	CPC-2502-M2176	PeptideMeter	2025-Q3	98.23	2.96	—	Buyer-sourced	0	FAIL
AX-2025-020847	CPC-2502-M2176	Janoshik	2025-Q3	99.25	3.41	102.8	Supplier-supplied	1	FAIL
AX-2025-020848	CPC-2502-M2176	Medutest	2025-Q3	98.13	3.32	97.4	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 CPC records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043319	BPC-157	CPC-2602-W1610	Medutest	2026-Q3	98.82	2.88	103.5	Buyer-sourced	2	MARGINAL
AX-2026-043295	Liraglutide	CPC-2602-G9942	Janoshik	2026-Q3	97.34	5.17	106.3	Buyer-sourced	0	FAIL
AX-2026-043288	Tirzepatide	CPC-2607-L1516	Janoshik	2026-Q3	96.89	5.11	101.1	Laboratory-retained	0	FAIL
AX-2026-043327	N-Acetyl Semax Amide	CPC-2602-D1905	Nordanalyt	2026-Q3	99.05	5.67	90.6	Buyer-sourced	1	FAIL
AX-2026-043328	N-Acetyl Semax Amide	CPC-2602-D1905	Janoshik	2026-Q3	99.49	6.83	100.9	Supplier-supplied	0	PASS
AX-2026-043257	L-Carnosine	CPC-2603-G9615	VendorInvestigate	2026-Q3	98.20	10.41	102.2	Buyer-sourced	0	FAIL
AX-2026-043297	Liraglutide	CPC-2602-G9942	Janoshik	2026-Q3	97.01	4.95	103.5	Buyer-sourced	0	FAIL
AX-2026-043331	N-Acetyl Semax Amide	CPC-2602-D1905	Janoshik	2026-Q3	99.46	6.22	—	Supplier-supplied	0	PASS