AssayIndex

AX-2024-004188

Kisspeptin-10 · 5 mg declared · Wuhan Wansheng Biotechnology Co., Ltd. · lot WWB-2311-T3203

MARGINALIDENTITY CONSISTENT
Report ID
AX-2024-004188
Compound
Kisspeptin-10
Compound class
Melanocortin-receptor peptides
Supplier
WWB — Wuhan Wansheng Biotechnology Co., Ltd.
Batch / lot
WWB-2311-T3203
Declared label claim
5mg
Laboratory
Medutest
Assay date
17 Jun 2024
Submitted
19 Jun 2024
Quarter
2024-Q2
Submitter
r.ferrari
Sample provenance
Supplier-supplied
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, 25 min gradient, 214 nm99.93% area≥ 98.5PASS
Total impuritiesRP-HPLC, sum of reported peaks0.07% area≤ 1.5PASS
Largest single impurityRP-HPLC — oxidised Trp (+16 Da)0.05% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula1301.6300DaNOT TESTED
Identity — observed monoisotopic massLC-MS, unit resolution (single quadrupole)1301.6197DaNOT TESTED
Mass accuracyobserved vs theoretical-7.9ppm± 15PASS
Peptide contentnot ordered on this submissionnot determinedrequired to check label claimNOT TESTED
Water contentKarl Fischer, coulometric, duplicate5.93%≤ 8.0PASS
Counter-ion (acetate)anion-exchange ion chromatography3.54%≤ 10.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.82%NOT TESTED
Endotoxinkinetic chromogenic LAL0.14EU/mg≤ 5.0PASS
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 procedureClear, colourless, no visible particulatesclear, no visible particulatesPASS
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration4.402.5 – 8.0PASS
Retention time (observed)RP-HPLC, 25 min gradient7.71min7.74 ± 0.25 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.460.960.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²78,249≥ 20,000PASS
Resolution to nearest impurityvs [D-Trp]-epimer0.88no 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.

0428385651284817130 Kisspeptin-107.71 min · 99.93 % 7.43 same trace · ×200 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 0481216202428 Retention time (min) Response (mAU)
Figure 1. RP-HPLC trace, 25 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 78,249, and skew follows the reported asymmetry factor of 0.96. 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 0.05 % impurity against a 99.93 % 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 peak7.714,856,90899.93
2oxidised Trp (+16 Da)7.432,4300.05+15.995
3[D-Trp]-epimer7.619720.020.000
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 1301.6300 Da, computed from C63H83N17O14. All ppm figures on this site are against monoisotopic values — see why that matters.

025507510032552572592511251325 [M+1H]1+1302.63[M+2H]2+651.82 m/z Relative abundance (%)
Figure 2. ESI charge-state envelope, unit-resolution instrument. Sticks are placed at m/z = (M + z × 1.007276)/z for the observed neutral mass of 1301.6197 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 (%)
3+434.8839434.8805-0.00347.6
2+651.8223651.8171-0.005253.6
1+1302.63731302.6270-0.0103100.0
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.

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)99.8899.93divergence +0.02 pp vs batch median
Total impurities (% area)0.120.07
Largest single impurity (% area)0.080.05
Water (%)not stated5.93
Counter-ion (%)not stated3.54
Peptide content (%w/w)91.7not determined
Endotoxin (EU/mg)0.100.14
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
Supplier-supplied
Evidentiary weight
Weaker evidence. Read with the caveat below.
Chain of custody
Supplier despatch → laboratory direct (courier, cold pack, 8 d) → assay. Submitter did not handle the vial.
Assay date
17 Jun 2024
Submitted to the index
19 Jun 2024
Laboratory
Medutest, Ljubljana, Slovenia
Method basis
25 min gradient · unit-resolution MS
Verification status
IDENTITY CONSISTENT
Section 6

Annotations

No annotations on this record. Annotations are short signed technical comments from index contributors; see how to contribute.

Section 7

Related records

Same batch — lot WWB-2311-T3203 n=13

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2024-004183WWB-2311-T3203VendorInvestigate2024-Q298.966.3297.8Buyer-sourced1MARGINAL
AX-2024-004184WWB-2311-T3203Janoshik2024-Q299.935.57Supplier-supplied1MARGINAL
AX-2024-004185WWB-2311-T3203Janoshik2024-Q299.246.1796.5Laboratory-retained1MARGINAL
AX-2024-004186WWB-2311-T3203Medutest2024-Q299.506.55Supplier-supplied2FAIL
AX-2024-004187WWB-2311-T3203VendorInvestigate2024-Q299.266.0792.9Buyer-sourced1MARGINAL
AX-2024-004189WWB-2311-T3203Janoshik2024-Q299.756.06Supplier-supplied1MARGINAL
AX-2024-004190WWB-2311-T3203Janoshik2024-Q299.936.05Supplier-supplied1MARGINAL
AX-2024-004191WWB-2311-T3203PeptideMeter2024-Q299.936.5197.4Supplier-supplied0PASS
AX-2024-004192WWB-2311-T3203Janoshik2024-Q299.936.30Supplier-supplied1MARGINAL
AX-2024-004193WWB-2311-T3203VendorInvestigate2024-Q299.555.8794.7Buyer-sourced1MARGINAL
AX-2024-004194WWB-2311-T3203Janoshik2024-Q299.866.4497.4Supplier-supplied1MARGINAL
AX-2024-004195WWB-2311-T3203Janoshik2024-Q299.866.45101.7Supplier-supplied1MARGINAL
Other recent Kisspeptin-10 records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042461SWBSWB-2603-D6238Janoshik2026-Q398.354.6596.5Supplier-supplied3FAIL
AX-2026-043176GL BiochemGLBI-2608-N8085Medutest2026-Q398.223.3092.5Buyer-sourced2FAIL
AX-2026-043180GL BiochemGLBI-2608-N8085Janoshik2026-Q398.693.37103.8Supplier-supplied2MARGINAL
AX-2026-042460SWBSWB-2603-D6238Kestrel2026-Q399.554.2190.8Supplier-supplied3MARGINAL
AX-2026-042458SWBSWB-2603-D6238Kestrel2026-Q398.514.71102.4Supplier-supplied3MARGINAL
AX-2026-043178GL BiochemGLBI-2608-N8085Janoshik2026-Q398.244.4496.0Supplier-supplied2FAIL
AX-2026-042463SWBSWB-2603-D6238Nordanalyt2026-Q398.354.9398.6Supplier-supplied3FAIL
AX-2026-042465SWBSWB-2603-D6238Kestrel2026-Q399.034.8396.4Supplier-supplied3MARGINAL
Other recent WWB records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041275LiraglutideWWB-2607-X2189Nordanalyt2026-Q399.615.0397.3Supplier-supplied0PASS
AX-2026-041387BPC-157WWB-2606-H3906Janoshik2026-Q398.954.64Laboratory-retained1MARGINAL
AX-2026-041334SemaglutideWWB-2606-N3192Janoshik2026-Q398.835.04Supplier-supplied1MARGINAL
AX-2026-041337SemaglutideWWB-2606-N3192Nordanalyt2026-Q398.964.81Supplier-supplied1MARGINAL
AX-2026-041385BPC-157WWB-2606-H3906Medutest2026-Q399.314.31Supplier-supplied1MARGINAL
AX-2026-041390BPC-157WWB-2606-H3906Medutest2026-Q399.474.8499.3Supplier-supplied1MARGINAL
AX-2026-041386BPC-157WWB-2606-H3906VendorInvestigate2026-Q399.324.8899.2Buyer-sourced1MARGINAL
AX-2026-041335SemaglutideWWB-2606-N3192Janoshik2026-Q399.554.55100.5Supplier-supplied1MARGINAL