AX-2026-042617 · KPV · GGPeps lot GGPE-2511-K8830

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	97.77	% area	≥ 99.0	FAIL
Total impurities	RP-HPLC, sum of reported peaks	2.23	% area	≤ 1.0	FAIL
Largest single impurity	RP-HPLC — acetyl-KPV (+42 Da)	1.31	% area	≤ 1.00	FAIL
Identity — theoretical monoisotopic mass	calculated from molecular formula	342.2267	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, high resolution (ESI-TOF/QTOF)	342.2274	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+2.1	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	83.75	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	81.88	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	22.73	mg	20 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	18.611	mg	20 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	93.1	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	4.66	%	≤ 10.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	10.69	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.90	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	14.67	EU/mg	≤ 5.0	FAIL
Sterility	not ordered on this submission	not determined	—	no growth	NOT TESTED
Appearance	visual, diffuse light, black and white background	White cake, partial shrinkage from vial wall	—	white to off-white intact cake	FAIL
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	5.19	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	5.28	min	5.24 ± 0.20 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.12	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	101,238	—	≥ 20,000	PASS
Resolution to nearest impurity	vs diketopiperazine (−18 Da)	2.20	—	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 101,238, and skew follows the reported asymmetry factor of 1.12. 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 1.31 % impurity against a 97.77 % 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	5.28	4,751,925	97.77	—
2	acetyl-KPV (+42 Da)	5.58	63,670	1.31	+42.011
3	diketopiperazine (−18 Da)	5.43	26,246	0.54	-18.011
4	Pro-Val dipeptide (−128 Da)	4.84	10,693	0.22	-128.095
5	Lys-Pro dipeptide (−99 Da)	4.92	7,776	0.16	-99.068
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 342.2274 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	343.2347	0.0007	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	4.66
Counter-ion (acetate)	ion chromatography	10.69
Residual solvent + inorganic residue	estimated	0.90
Total peptide content	by difference	83.75
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)	98.71	97.77	divergence +0.10 pp vs batch median
Total impurities (% area)	1.29	2.23
Largest single impurity (% area)	not stated	1.31
Water (%)	2.7	4.66
Counter-ion (%)	not stated	10.69
Peptide content (%w/w)	not stated	83.75
Endotoxin (EU/mg)	8.30	14.67
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: Domestic warehouse despatch → submitter (2–8 °C, 6 d) → laboratory (courier, cold pack, 7 d) → assay.
Assay date: 12 Apr 2026
Submitted to the index: 03 May 2026
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.

lal_assay03 May 2026

14.67 EU/mg is above the index screening threshold of 5.0. Two things to keep separate: the index threshold is a screening figure, and a real limit is dose-dependent. The endotoxin dose-limit calculator does that arithmetic. What this record establishes is that the burden is measurable and high relative to the rest of the dataset.

price_per_mg03 May 2026

Endotoxin determined but the LAL method is not stated. Kinetic chromogenic and gel-clot give different results and different sensitivity. The value cannot be interpreted without knowing which.

coa_gap03 May 2026

High endotoxin 14.67 EU/mg on high-purity material vs purity suggests water quality at the fill step. If the lot was lyophilised from non-purified water, this is the expected finding.

repackager03 May 2026

Endotoxin assay but no bacterial viability or total count. The two are independent: dead endotoxin-bearing bacteria contribute to the burden, living ones that produce endotoxins do not.

Section 7

Related records

Same batch — lot GGPE-2511-K8830 n=10

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042616	GGPE-2511-K8830	Medutest	2026-Q2	98.67	5.59	—	Supplier-supplied	1	FAIL
AX-2026-042618	GGPE-2511-K8830	Janoshik	2026-Q2	98.62	5.19	103.1	Supplier-supplied	1	FAIL
AX-2026-042619	GGPE-2511-K8830	Nordanalyt	2026-Q2	98.59	4.57	97.5	Supplier-supplied	2	FAIL
AX-2026-042620	GGPE-2511-K8830	Janoshik	2026-Q2	98.40	4.83	95.9	Supplier-supplied	1	FAIL
AX-2026-042621	GGPE-2511-K8830	Janoshik	2026-Q2	98.74	5.02	99.7	Supplier-supplied	1	FAIL
AX-2026-042622	GGPE-2511-K8830	PeptideMeter	2026-Q2	98.62	5.19	—	Supplier-supplied	1	FAIL
AX-2026-042623	GGPE-2511-K8830	VendorInvestigate	2026-Q2	97.47	5.07	103.3	Buyer-sourced	1	FAIL
AX-2026-042624	GGPE-2511-K8830	Nordanalyt	2026-Q2	98.14	4.25	90.1	Buyer-sourced	0	FAIL
AX-2026-042625	GGPE-2511-K8830	Medutest	2026-Q2	98.78	4.69	—	Supplier-supplied	1	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-2026-042618	GGPeps	GGPE-2511-K8830	Janoshik	2026-Q2	98.62	5.19	103.1	Supplier-supplied	1	FAIL
AX-2026-042624	GGPeps	GGPE-2511-K8830	Nordanalyt	2026-Q2	98.14	4.25	90.1	Buyer-sourced	0	FAIL
AX-2026-042619	GGPeps	GGPE-2511-K8830	Nordanalyt	2026-Q2	98.59	4.57	97.5	Supplier-supplied	2	FAIL
AX-2026-042623	GGPeps	GGPE-2511-K8830	VendorInvestigate	2026-Q2	97.47	5.07	103.3	Buyer-sourced	1	FAIL
AX-2026-042622	GGPeps	GGPE-2511-K8830	PeptideMeter	2026-Q2	98.62	5.19	—	Supplier-supplied	1	FAIL
AX-2026-042616	GGPeps	GGPE-2511-K8830	Medutest	2026-Q2	98.67	5.59	—	Supplier-supplied	1	FAIL
AX-2026-042621	GGPeps	GGPE-2511-K8830	Janoshik	2026-Q2	98.74	5.02	99.7	Supplier-supplied	1	FAIL
AX-2026-042625	GGPeps	GGPE-2511-K8830	Medutest	2026-Q2	98.78	4.69	—	Supplier-supplied	1	FAIL

Other recent GGPeps records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042737	Selank	GGPE-2603-J9708	Janoshik	2026-Q3	98.40	9.14	97.4	Buyer-sourced	0	FAIL
AX-2026-042804	Selank	GGPE-2602-G2056	Janoshik	2026-Q3	98.50	7.97	—	Supplier-supplied	0	FAIL
AX-2026-042803	Selank	GGPE-2602-G2056	Janoshik	2026-Q3	98.48	8.01	—	Laboratory-retained	1	FAIL
AX-2026-042802	Selank	GGPE-2602-G2056	Janoshik	2026-Q3	98.74	7.09	96.0	Supplier-supplied	0	FAIL
AX-2026-042796	Selank	GGPE-2602-G2056	Janoshik	2026-Q3	98.26	7.56	97.5	Buyer-sourced	0	FAIL
AX-2026-042648	Melanotan II	GGPE-2603-P8735	Janoshik	2026-Q3	99.10	6.97	—	Supplier-supplied	4	MARGINAL
AX-2026-042797	Selank	GGPE-2602-G2056	Medutest	2026-Q3	98.46	7.92	—	Buyer-sourced	0	FAIL
AX-2026-042669	CJC-1295 (no DAC)	GGPE-2606-E8495	Medutest	2026-Q3	98.61	4.06	95.5	Supplier-supplied	0	PASS