AssayIndex

AX-2024-005193

Kisspeptin-10 · 5 mg declared · Chinese Peptide Company Co., Ltd. · lot CPC-2411-W9644

MARGINALMETHOD LIMITED
Report ID
AX-2024-005193
Compound
Kisspeptin-10
Compound class
Melanocortin-receptor peptides
Supplier
CPC — Chinese Peptide Company Co., Ltd.
Batch / lot
CPC-2411-W9644
Declared label claim
5mg
Laboratory
Kestrel Bioanalytical
Assay date
26 Nov 2024
Submitted
28 Nov 2024
Quarter
2024-Q4
Submitter
m.asante
Sample provenance
Buyer-sourced
Section 1

Results

Measured against the index acceptance specification for the melanocortin-receptor 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, 15 min gradient, 214 nm99.53% area≥ 98.5PASS
Total impuritiesRP-HPLC, sum of reported peaks0.47% area≤ 1.5PASS
Largest single impurityRP-HPLC — [D-Trp]-epimer0.26% area≤ 1.00PASS
Identitynot ordered on this submissionnot determinedrequired for VERIFIED statusNOT TESTED
Total peptide contentby difference from the gravimetric mass balance91.06%w/wNOT TESTED
Target-compound contenttotal peptide content × purity90.63%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen5.81mg5 mg declaredNOT TESTED
Recovered target peptidegross fill × target content5.266mg5 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim105.3%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate3.93%≤ 8.0PASS
Counter-ion (acetate)anion-exchange ion chromatography4.21%≤ 10.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.80%NOT TESTED
Endotoxinnot ordered on this submissionnot determined≤ 5.0NOT TESTED
Sterilitymembrane filtration, USP <71>, 14 dNo growth at 14 dno growthPASS
Appearancevisual, diffuse light, black and white backgroundWhite to pale-yellow cake, intactwhite to off-white intact cakePASS
Reconstitution clarityreconstituted per submitter procedureClear with a single visible fibreclear, no visible particulatesFAIL
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration5.062.5 – 8.0PASS
Retention time (observed)RP-HPLC, 15 min gradient4.06min4.94 ± 0.25 (normalised)FAIL
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.030.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²57,222≥ 20,000PASS
Resolution to nearest impurityvs [D-Trp]-epimer0.86no 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.

06688133762006426752 Kisspeptin-104.06 min · 99.53 % 4.00 same trace · ×200 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 048121620 Retention time (min) Response (mAU)
Figure 1. RP-HPLC trace, 15 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 57,222, and skew follows the reported asymmetry factor of 1.03. 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 0.26 % impurity against a 99.53 % main peak is a line two pixels tall; the main peak runs off-scale there by design.
#PeakRTArea (µV·s)% areaΔ mass (Da)
1Kisspeptin-10 — main peak4.064,837,46799.53
2[D-Trp]-epimer4.0012,6370.260.000
3C-terminal free acid (+1 Da)4.154,3740.09+0.984
4oxidised Trp (+16 Da)3.893,8880.08+15.995
5des-Tyr (−163 Da)3.781,9440.04-163.063
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 Fischer3.93
Counter-ion (acetate)ion chromatography4.21
Residual solvent + inorganic residueestimated0.80
Total peptide contentby difference91.06
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)99.1599.53divergence +0.49 pp vs batch median
Total impurities (% area)0.850.47
Largest single impurity (% area)0.570.26
Water (%)not stated3.93
Counter-ion (%)not stated4.21
Peptide content (%w/w)not stated91.06
Endotoxin (EU/mg)0.73not determined
Method stated on certificateYEScolumn, 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
Retail purchase → submitter (ambient, 24 d) → laboratory (courier, cold pack, 4 d) → assay.
Assay date
26 Nov 2024
Submitted to the index
28 Nov 2024
Laboratory
Kestrel Bioanalytical, Melbourne, Australia
Method basis
15 min gradient · unit-resolution MS
Verification status
METHOD LIMITED
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.

prep_hplc_cut
0.47 % total impurities on Kisspeptin-10 means the preparative fraction was cut narrow. That trades yield for purity, and the trade was made in the buyer's favour on this lot.
Alkylation artefacts from a scavenger-poor cleavage would appear as a +58 or +76 family here. Absent, which says the cleavage was run properly.
price_per_mg
The index cannot verify that the vial assayed is representative of the lot it came from, and says so on every record. Provenance narrows that gap; it does not close it.
plate_count
Efficiency is the lever that does not change selectivity, so it improves resolution without moving anything else. Longer column, smaller particle, or lower flow, in that order of cost.
Section 7

Related records

Same batch — lot CPC-2411-W9644 n=8

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2024-005188CPC-2411-W9644PeptideMeter2024-Q499.284.10Supplier-supplied0PASS
AX-2024-005189CPC-2411-W9644Janoshik2024-Q498.703.73Buyer-sourced0PASS
AX-2024-005190CPC-2411-W9644Janoshik2024-Q498.603.69Buyer-sourced0PASS
AX-2024-005191CPC-2411-W9644Janoshik2024-Q498.373.82100.4Buyer-sourced0FAIL
AX-2024-005192CPC-2411-W9644Janoshik2024-Q498.763.76Buyer-sourced0PASS
AX-2025-020793CPC-2411-W9644Nordanalyt2024-Q498.623.7391.8Buyer-sourced0PASS
AX-2024-005194CPC-2411-W9644Nordanalyt2024-Q498.553.8499.4Buyer-sourced0PASS
Other recent Kisspeptin-10 records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043179GL BiochemGLBI-2608-N7715Medutest2026-Q398.974.37Buyer-sourced1MARGINAL
AX-2026-043178GL BiochemGLBI-2608-N7715Janoshik2026-Q398.504.55Buyer-sourced1MARGINAL
AX-2026-043184GL BiochemGLBI-2608-N7715Janoshik2026-Q398.993.63100.6Supplier-supplied1MARGINAL
AX-2026-043185GL BiochemGLBI-2608-N7715Medutest2026-Q398.713.71107.0Buyer-sourced1MARGINAL
AX-2026-043182GL BiochemGLBI-2608-N7715Janoshik2026-Q398.933.8695.7Buyer-sourced1MARGINAL
AX-2026-043183GL BiochemGLBI-2608-N7715PeptideMeter2026-Q398.544.17102.2Buyer-sourced1MARGINAL
AX-2026-043186GL BiochemGLBI-2608-N7715Janoshik2026-Q398.563.6096.8Buyer-sourced1MARGINAL
AX-2026-043181GL BiochemGLBI-2608-N7715Janoshik2026-Q398.774.0695.2Buyer-sourced1MARGINAL
Other recent CPC records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043319BPC-157CPC-2602-W1610Medutest2026-Q398.822.88103.5Buyer-sourced2MARGINAL
AX-2026-043295LiraglutideCPC-2602-G9942Janoshik2026-Q397.345.17106.3Buyer-sourced0FAIL
AX-2026-043288TirzepatideCPC-2607-L1516Janoshik2026-Q396.895.11101.1Laboratory-retained0FAIL
AX-2026-043327N-Acetyl Semax AmideCPC-2602-D1905Nordanalyt2026-Q399.055.6790.6Buyer-sourced1FAIL
AX-2026-043328N-Acetyl Semax AmideCPC-2602-D1905Janoshik2026-Q399.496.83100.9Supplier-supplied0PASS
AX-2026-043257L-CarnosineCPC-2603-G9615VendorInvestigate2026-Q398.2010.41102.2Buyer-sourced0FAIL
AX-2026-043297LiraglutideCPC-2602-G9942Janoshik2026-Q397.014.95103.5Buyer-sourced0FAIL
AX-2026-043331N-Acetyl Semax AmideCPC-2602-D1905Janoshik2026-Q399.466.22Supplier-supplied0PASS