AssayIndex

AX-2025-019359

LL-37 · 1 mg declared · Tianjin Finder Chemical Co., Ltd. · lot TFC-2410-N7616

FAILVERIFIED
Report ID
AX-2025-019359
Compound
LL-37
Compound class
Tissue-repair and immunomodulatory peptides
Supplier
TFC — Tianjin Finder Chemical Co., Ltd.
Batch / lot
TFC-2410-N7616
Declared label claim
1mg
Laboratory
Nordanalyt Laboratories
Assay date
28 Mar 2025
Submitted
13 Apr 2025
Quarter
2025-Q1
Submitter
fa.sjoberg
Sample provenance
Supplier-supplied
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.

ParameterMethodResultUnitIndex spec
PurityRP-HPLC, 35 min gradient, 214 nm98.25% area≥ 96.5PASS
Total impuritiesRP-HPLC, sum of reported peaks1.75% area≤ 3.5PASS
Largest single impurityRP-HPLC — deamidated (+1 Da)0.92% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula4490.4265Da—NOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)4490.4481Da—NOT TESTED
Mass accuracyobserved vs theoretical+4.8ppm± 15PASS
Peptide contentnot ordered on this submissionnot determined—required to check label claimNOT TESTED
Water contentKarl Fischer, coulometric, duplicate3.67%≤ 10.0PASS
Counter-ion (TFA)anion-exchange ion chromatography6.64%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.70%—NOT TESTED
Endotoxinkinetic chromogenic LAL10.38EU/mg≤ 5.0FAIL
Sterilitynot ordered on this submissionnot determined—no growthNOT TESTED
Appearancevisual, diffuse light, black and white backgroundOff-white lyophilised cake, intact—white to off-white intact cakePASS
Reconstitution clarityreconstituted per submitter procedureClear, colourless, no visible particulates—clear, no visible particulatesPASS
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration4.30—2.5 – 8.0PASS
Retention time (observed)RP-HPLC, 35 min gradient16.51min16.56 ± 0.40 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.10—0.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²45,935—≥ 20,000PASS
Resolution to nearest impurityvs deamidated (+1 Da)0.96—no index criterionREPORTED
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.

01406281242185624 LL-3716.51 min · 98.25 % 16.2119.84 same trace · ×50 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 0510152025303540 Retention time (min) Response (mAU)
Figure 1. RP-HPLC trace, 35 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 45,935, and skew follows the reported asymmetry factor of 1.10. 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 0.92 % impurity against a 98.25 % main peak is a line two pixels tall; the main peak runs off-scale there by design.
#PeakRTArea (µV·s)% areaΔ mass (Da)
1LL-37 — main peak16.514,775,25598.25—
2deamidated (+1 Da)16.2144,7150.92+0.984
3truncated (1-31)14.5528,6760.59-709.401
4trifluoroacetyl adduct (+96 Da)17.495,8320.12+95.982
5des-Leu1 (−113 Da)16.073,8880.08-113.084
6aggregated multimer19.841,9440.040.000
Closure check — purity + Σ impurities 100.00CLOSES

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.

02550751006508009501100125014001550 [M+4H]4+1123.62[M+5H]5+899.10[M+3H]3+1497.82 m/z Relative abundance (%)
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 4490.4481 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.
ChargeTheoretical m/zObserved m/zΔ m/zRel. abundance (%)
6+749.4117749.41530.00368.4
5+899.0926899.09690.004354.4
4+1123.61391123.61930.0054100.0
3+1497.81611497.82330.007253.2
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.

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.

FigureSupplier COAThis reportIndex note
Purity (% area)98.8598.25divergence +0.68 pp vs batch median
Total impurities (% area)1.151.75
Largest single impurity (% area)0.740.92
Water (%)1.83.67
Counter-ion (%)not stated6.64
Peptide content (%w/w)not statednot determined
Endotoxin (EU/mg)not stated10.38
Method stated on certificateNO—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, 6 d) → assay. Submitter did not handle the vial.
Assay date
28 Mar 2025
Submitted to the index
13 Apr 2025
Laboratory
Nordanalyt Laboratories, Uppsala, Sweden
Method basis
35 min gradient · high-resolution MS
Verification status
VERIFIED
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.

macrolactam
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.
spec_vs_result
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.
gradient_25
High endotoxin 10.38 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.
fill_homogeneity
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 TFC-2410-N7616 n=10

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2025-019357TFC-2410-N7616VendorInvestigate2025-Q198.064.09107.5Buyer-sourced1MARGINAL
AX-2025-019358TFC-2410-N7616PeptideMeter2025-Q198.193.79—Supplier-supplied1MARGINAL
AX-2025-019360TFC-2410-N7616PeptideMeter2025-Q198.143.8696.6Supplier-supplied1MARGINAL
AX-2025-019361TFC-2410-N7616Janoshik2025-Q198.303.9894.9Supplier-supplied1MARGINAL
AX-2025-019362TFC-2410-N7616PeptideMeter2025-Q197.514.3395.5Supplier-supplied2FAIL
AX-2025-019363TFC-2410-N7616Janoshik2025-Q198.334.18—Supplier-supplied1MARGINAL
AX-2025-019364TFC-2410-N7616Janoshik2025-Q198.034.59104.4Buyer-sourced1MARGINAL
AX-2025-019365TFC-2410-N7616Janoshik2025-Q197.994.0392.0Supplier-supplied0PASS
AX-2025-019366TFC-2410-N7616Nordanalyt2025-Q198.633.6298.1Supplier-supplied1MARGINAL

Cross-sections

Other recent LL-37 records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042216HomopeptideHOMO-2602-G1280Kestrel2026-Q398.975.3093.4Supplier-supplied1MARGINAL
AX-2026-042215HomopeptideHOMO-2602-G1280PeptideMeter2026-Q399.835.3689.9Supplier-supplied1MARGINAL
AX-2026-042217HomopeptideHOMO-2602-G1280Janoshik2026-Q399.435.69105.8Supplier-supplied1MARGINAL
AX-2026-042221HomopeptideHOMO-2602-G1280Janoshik2026-Q399.585.6296.7Supplier-supplied1MARGINAL
AX-2026-042210HomopeptideHOMO-2602-G1280PeptideMeter2026-Q399.365.23—Supplier-supplied1MARGINAL
AX-2026-042211HomopeptideHOMO-2602-G1280Medutest2026-Q399.235.76101.5Supplier-supplied1MARGINAL
AX-2026-042214HomopeptideHOMO-2602-G1280Kestrel2026-Q399.935.81—Supplier-supplied0PASS
AX-2026-042212HomopeptideHOMO-2602-G1280Janoshik2026-Q399.015.59105.5Supplier-supplied1MARGINAL
Other recent TFC records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041932SemaglutideTFC-2604-X4301Janoshik2026-Q398.884.31—Supplier-supplied0PASS
AX-2026-042067SS-31 (Elamipretide)TFC-2604-Y7472Kestrel2026-Q398.664.44—Supplier-supplied1MARGINAL
AX-2026-042057SermorelinTFC-2605-Y6440Janoshik2026-Q398.683.9498.3Supplier-supplied0PASS
AX-2026-041936SemaglutideTFC-2604-X4301PeptideMeter2026-Q398.624.30—Buyer-sourced1MARGINAL
AX-2026-041973Humanin (HNG)TFC-2605-U5564Janoshik2026-Q399.627.03—Supplier-supplied2FAIL
AX-2026-041980Humanin (HNG)TFC-2605-U5564Janoshik2026-Q399.907.0188.6Supplier-supplied2MARGINAL
AX-2026-041961TirzepatideTFC-2605-G5134Medutest2026-Q398.257.11—Supplier-supplied2MARGINAL
AX-2026-042068SS-31 (Elamipretide)TFC-2604-Y7472Medutest2026-Q398.713.6392.9Supplier-supplied2MARGINAL