AssayIndex

AX-2025-020479

KPV · 10 mg declared · Zhuhai Kerui Biotechnology Co., Ltd. · lot KP-2509-N5703

FAILPURITY ONLY
Report ID
AX-2025-020479
Compound
KPV
Compound class
Tissue-repair and immunomodulatory peptides
Supplier
KP — Zhuhai Kerui Biotechnology Co., Ltd.
Batch / lot
KP-2509-N5703
Declared label claim
10mg
Laboratory
PeptideMeter
Assay date
05 Oct 2025
Submitted
21 Oct 2025
Quarter
2025-Q4
Submitter
la.boateng
Sample provenance
Buyer-sourced
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, 28 min gradient, 214 nm99.19% area≥ 99.0PASS
Total impuritiesRP-HPLC, sum of reported peaks0.81% area≤ 1.0PASS
Largest single impurityRP-HPLC — Pro-Val dipeptide (−128 Da)0.58% area≤ 1.00PASS
Identitynot ordered on this submissionnot determinedrequired for VERIFIED statusNOT TESTED
Total peptide contentby difference from the gravimetric mass balance83.96%w/wNOT TESTED
Target-compound contenttotal peptide content × purity83.28%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen11.01mg10 mg declaredNOT TESTED
Recovered target peptidegross fill × target content9.169mg10 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim91.7%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate2.44%≤ 10.0PASS
Counter-ion (acetate)anion-exchange ion chromatography13.46%≤ 12.0FAIL
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.14%NOT TESTED
Endotoxinnot ordered on this submissionnot determined≤ 5.0NOT TESTED
Sterilitynot ordered on this submissionnot determinedno growthNOT TESTED
Appearancevisual, diffuse light, black and white backgroundWhite lyophilised cake, intactwhite to off-white intact cakePASS
Reconstitution clarityreconstituted per submitter procedureFaint haze, clearing on standingclear, no visible particulatesFAIL
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration5.522.5 – 8.0PASS
Retention time (observed)RP-HPLC, 28 min gradient4.95min4.92 ± 0.20 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.460.920.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²74,946≥ 20,000PASS
Resolution to nearest impurityvs diketopiperazine (−18 Da)1.89no 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.

06615132291984426459 KPV4.95 min · 99.19 % 4.54 same trace · ×100 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 051015202530 Retention time (min) Response (mAU)
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 74,946, and skew follows the reported asymmetry factor of 0.92. 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 0.58 % impurity against a 99.19 % main peak is a line two pixels tall; the main peak runs off-scale there by design.
#PeakRTArea (µV·s)% areaΔ mass (Da)
1KPV — main peak4.954,820,94199.19
2Pro-Val dipeptide (−128 Da)4.5428,1900.58-128.095
3diketopiperazine (−18 Da)5.095,3460.11-18.011
4Lys-Pro dipeptide (−99 Da)4.613,4020.07-99.068
5acetyl-KPV (+42 Da)5.232,4300.05+42.011
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 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.

ComponentDetermination%w/w of cake
WaterKarl Fischer2.44
Counter-ion (acetate)ion chromatography13.46
Residual solvent + inorganic residueestimated0.14
Total peptide contentby difference83.96
Total100.00 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.

FigureSupplier COAThis reportIndex note
Purity (% area)99.5199.19divergence +0.35 pp vs batch median
Total impurities (% area)0.490.81
Largest single impurity (% area)not stated0.58
Water (%)0.72.44
Counter-ion (%)not stated13.46
Peptide content (%w/w)94.583.96
Endotoxin (EU/mg)0.18not determined
Method stated on certificateNOno 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
Retail purchase → submitter (ambient, 3 d) → laboratory (courier, cold pack, 10 d) → assay.
Assay date
05 Oct 2025
Submitted to the index
21 Oct 2025
Laboratory
PeptideMeter, Tallinn, Estonia
Method basis
28 min gradient · high-resolution MS
Verification status
PURITY ONLY
Section 6

Annotations 3

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.

counterion_mol
Check the stoichiometry: 13.46 % acetate is close to what the number of basic residues in KPV predicts, so this is the expected salt rather than an excess. The arithmetic is on the counter-ion method page.
ash_sulfated
Total inorganic residue, counter-ion and water are the three non-peptide slots. Where all three are measured the balance is closed and the remainder is real peptide. This record has all three.
label_claim
Recovered mass follows from the balance and nothing else. 9.17 mg against 10 mg is 91.7 %, and every term in that is a measured quantity on this record.
Section 7

Related records

Same batch — lot KP-2509-N5703 n=7

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2025-020477KP-2509-N5703Janoshik2025-Q499.051.9999.2Buyer-sourced0PASS
AX-2026-043084KP-2509-N5703Janoshik2025-Q498.892.7396.0Buyer-sourced0FAIL
AX-2025-020478KP-2509-N5703PeptideMeter2025-Q499.252.32Buyer-sourced0FAIL
AX-2025-020480KP-2509-N5703Janoshik2025-Q498.962.31Buyer-sourced0FAIL
AX-2025-020481KP-2509-N5703Janoshik2025-Q499.432.54Buyer-sourced0FAIL
AX-2025-020482KP-2509-N5703Janoshik2025-Q499.162.2699.0Buyer-sourced0PASS
Other recent KPV records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042742GGPepsGGPE-2511-K1569Janoshik2026-Q298.405.09Buyer-sourced0FAIL
AX-2026-042259TFCTFC-2508-M9624Janoshik2026-Q199.933.3889.4Buyer-sourced1FAIL
AX-2026-042078HYBHYB-2511-P7317Nordanalyt2026-Q199.593.9298.8Buyer-sourced0PASS
AX-2026-042262TFCTFC-2508-M9624Janoshik2026-Q199.893.3292.2Buyer-sourced0FAIL
AX-2026-042260TFCTFC-2508-M9624PeptideMeter2026-Q199.932.8999.2Buyer-sourced0FAIL
AX-2026-042079HYBHYB-2511-P7317Janoshik2026-Q199.685.6794.7Buyer-sourced0FAIL
AX-2026-042257TFCTFC-2508-M9624Janoshik2026-Q199.542.8195.6Buyer-sourced0FAIL
AX-2026-042261TFCTFC-2508-M9624Medutest2026-Q199.933.2097.1Buyer-sourced0FAIL
Other recent KP records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043095RetatrutideKP-2607-H5774Janoshik2026-Q395.815.48105.2Buyer-sourced0FAIL
AX-2026-043094RetatrutideKP-2607-H5774PeptideMeter2026-Q396.326.40Buyer-sourced0FAIL
AX-2026-043096RetatrutideKP-2607-H5774VendorInvestigate2026-Q396.486.05104.9Buyer-sourced0FAIL
AX-2026-043090RetatrutideKP-2607-H5774Janoshik2026-Q396.465.81Buyer-sourced0FAIL
AX-2026-043091RetatrutideKP-2607-H5774Janoshik2026-Q396.135.94Buyer-sourced0FAIL
AX-2026-043077TB-500KP-2605-C5214Janoshik2026-Q299.615.6490.2Buyer-sourced0PASS
AX-2026-043093RetatrutideKP-2607-H5774Janoshik2026-Q396.545.54Buyer-sourced0PASS
AX-2026-043092RetatrutideKP-2607-H5774Medutest2026-Q396.646.12Buyer-sourced1FAIL