AX-2025-019362 · LL-37 · TFC lot TFC-2410-N7616

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, 28 min gradient, 214 nm	97.51	% area	≥ 96.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	2.49	% area	≤ 3.5	PASS
Largest single impurity	RP-HPLC — truncated (1-31)	1.03	% area	≤ 1.00	FAIL
Identity — theoretical monoisotopic mass	calculated from molecular formula	4490.4265	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, high resolution (ESI-TOF/QTOF)	4490.4310	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+1.0	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	87.44	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	85.26	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	1.12	mg	1 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	0.955	mg	1 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	95.5	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	4.33	%	≤ 10.0	PASS
Counter-ion (TFA)	anion-exchange ion chromatography	7.41	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.82	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	7.95	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 lyophilised cake, intact	—	white to off-white intact cake	PASS
Reconstitution clarity	reconstituted per submitter procedure	Clear with a single visible fibre	—	clear, no visible particulates	FAIL
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	3.00	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 28 min gradient	13.40	min	13.48 ± 0.40 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.21	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	51,054	—	≥ 20,000	PASS
Resolution to nearest impurity	vs deamidated (+1 Da)	1.00	—	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, 28 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 51,054, and skew follows the reported asymmetry factor of 1.21. 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 1.03 % impurity against a 97.51 % 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	LL-37 — main peak	13.40	4,739,288	97.51	—
2	truncated (1-31)	11.83	50,061	1.03	-709.401
3	deamidated (+1 Da)	13.16	33,050	0.68	+0.984
4	aggregated multimer	16.06	17,983	0.37	0.000
5	trifluoroacetyl adduct (+96 Da)	14.18	11,665	0.24	+95.982
6	des-Leu1 (−113 Da)	13.05	8,263	0.17	-113.084
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 4490.4265 Da, computed from C205H340N60O53. 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 4490.4310 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 (%)
6+	749.4117	749.4124	0.0007	9.3
5+	899.0926	899.0935	0.0009	56.6
4+	1123.6139	1123.6150	0.0011	100.0
3+	1497.8161	1497.8176	0.0015	54.0

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	4.33
Counter-ion (TFA)	ion chromatography	7.41
Residual solvent + inorganic residue	estimated	0.82
Total peptide content	by difference	87.44
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)	98.85	97.51	divergence +0.68 pp vs batch median
Total impurities (% area)	1.15	2.49
Largest single impurity (% area)	0.74	1.03
Water (%)	1.8	4.33
Counter-ion (%)	not stated	7.41
Peptide content (%w/w)	not stated	87.44
Endotoxin (EU/mg)	not stated	7.95
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: Supplier-supplied
Evidentiary weight: Weaker evidence. Read with the caveat below.
Chain of custody: Supplier despatch → laboratory direct (courier, cold pack, 7 d) → assay. Submitter did not handle the vial.
Assay date: 19 Mar 2025
Submitted to the index: 02 Apr 2025
Laboratory: PeptideMeter, Tallinn, Estonia
Method basis: 28 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_assay02 Apr 2025

7.95 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.

quad_unit02 Apr 2025

No endotoxin figure on this record, which is true of roughly three quarters of the index. It is the one measurement that cannot be inferred from any other and the one most often omitted.

amino_mq_nitro02 Apr 2025

High endotoxin 7.95 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.

iso_audit02 Apr 2025

Endotoxin undetectable means below the detection limit of on PeptideMeter's system. That does not mean zero and may not reflect actual endotoxin. The cutoff is useful for screening; the absence of a number is not a guarantee.

Section 7

Related records

Same batch — lot TFC-2410-N7616 n=10

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-019357	TFC-2410-N7616	VendorInvestigate	2025-Q1	98.06	4.09	107.5	Buyer-sourced	1	MARGINAL
AX-2025-019358	TFC-2410-N7616	PeptideMeter	2025-Q1	98.19	3.79	—	Supplier-supplied	1	MARGINAL
AX-2025-019359	TFC-2410-N7616	Nordanalyt	2025-Q1	98.25	3.67	—	Supplier-supplied	2	FAIL
AX-2025-019360	TFC-2410-N7616	PeptideMeter	2025-Q1	98.14	3.86	96.6	Supplier-supplied	1	MARGINAL
AX-2025-019361	TFC-2410-N7616	Janoshik	2025-Q1	98.30	3.98	94.9	Supplier-supplied	1	MARGINAL
AX-2025-019363	TFC-2410-N7616	Janoshik	2025-Q1	98.33	4.18	—	Supplier-supplied	1	MARGINAL
AX-2025-019364	TFC-2410-N7616	Janoshik	2025-Q1	98.03	4.59	104.4	Buyer-sourced	1	MARGINAL
AX-2025-019365	TFC-2410-N7616	Janoshik	2025-Q1	97.99	4.03	92.0	Supplier-supplied	0	PASS
AX-2025-019366	TFC-2410-N7616	Nordanalyt	2025-Q1	98.63	3.62	98.1	Supplier-supplied	1	MARGINAL

Batch rollup and reproducibility assessment →

Cross-sections

Other recent LL-37 records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042216	Homopeptide	HOMO-2602-G1280	Kestrel	2026-Q3	98.97	5.30	93.4	Supplier-supplied	1	MARGINAL
AX-2026-042215	Homopeptide	HOMO-2602-G1280	PeptideMeter	2026-Q3	99.83	5.36	89.9	Supplier-supplied	1	MARGINAL
AX-2026-042217	Homopeptide	HOMO-2602-G1280	Janoshik	2026-Q3	99.43	5.69	105.8	Supplier-supplied	1	MARGINAL
AX-2026-042221	Homopeptide	HOMO-2602-G1280	Janoshik	2026-Q3	99.58	5.62	96.7	Supplier-supplied	1	MARGINAL
AX-2026-042210	Homopeptide	HOMO-2602-G1280	PeptideMeter	2026-Q3	99.36	5.23	—	Supplier-supplied	1	MARGINAL
AX-2026-042211	Homopeptide	HOMO-2602-G1280	Medutest	2026-Q3	99.23	5.76	101.5	Supplier-supplied	1	MARGINAL
AX-2026-042214	Homopeptide	HOMO-2602-G1280	Kestrel	2026-Q3	99.93	5.81	—	Supplier-supplied	0	PASS
AX-2026-042212	Homopeptide	HOMO-2602-G1280	Janoshik	2026-Q3	99.01	5.59	105.5	Supplier-supplied	1	MARGINAL

Other recent TFC records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041932	Semaglutide	TFC-2604-X4301	Janoshik	2026-Q3	98.88	4.31	—	Supplier-supplied	0	PASS
AX-2026-042067	SS-31 (Elamipretide)	TFC-2604-Y7472	Kestrel	2026-Q3	98.66	4.44	—	Supplier-supplied	1	MARGINAL
AX-2026-042057	Sermorelin	TFC-2605-Y6440	Janoshik	2026-Q3	98.68	3.94	98.3	Supplier-supplied	0	PASS
AX-2026-041936	Semaglutide	TFC-2604-X4301	PeptideMeter	2026-Q3	98.62	4.30	—	Buyer-sourced	1	MARGINAL
AX-2026-041973	Humanin (HNG)	TFC-2605-U5564	Janoshik	2026-Q3	99.62	7.03	—	Supplier-supplied	2	FAIL
AX-2026-041980	Humanin (HNG)	TFC-2605-U5564	Janoshik	2026-Q3	99.90	7.01	88.6	Supplier-supplied	2	MARGINAL
AX-2026-041961	Tirzepatide	TFC-2605-G5134	Medutest	2026-Q3	98.25	7.11	—	Supplier-supplied	2	MARGINAL
AX-2026-042068	SS-31 (Elamipretide)	TFC-2604-Y7472	Medutest	2026-Q3	98.71	3.63	92.9	Supplier-supplied	2	MARGINAL