AssayIndex

AX-2024-004183

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

MARGINALVERIFIED
Report ID
AX-2024-004183
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
VendorInvestigate
Assay date
20 Jun 2024
Submitted
15 Jul 2024
Quarter
2024-Q2
Submitter
b.espinoza
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, 32 min gradient, 214 nm98.96% area≥ 98.5PASS
Total impuritiesRP-HPLC, sum of reported peaks1.04% area≤ 1.5PASS
Largest single impurityRP-HPLC — des-Tyr (−163 Da)0.69% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula1301.6300DaNOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)1301.6261DaNOT TESTED
Mass accuracyobserved vs theoretical-3.0ppm± 15PASS
Total peptide contentby difference from the gravimetric mass balance89.02%w/wNOT TESTED
Target-compound contenttotal peptide content × purity88.09%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen5.55mg5 mg declaredNOT TESTED
Recovered target peptidegross fill × target content4.889mg5 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim97.8%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate6.32%≤ 8.0PASS
Counter-ion (acetate)anion-exchange ion chromatography4.21%≤ 10.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.45%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 cake, partial shrinkage from vial wallwhite to off-white intact cakeFAIL
Reconstitution clarityreconstituted per submitter procedureFaint haze, clearing on standingclear, no visible particulatesFAIL
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration5.862.5 – 8.0PASS
Retention time (observed)RP-HPLC, 32 min gradient9.61min9.70 ± 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)²75,343≥ 20,000PASS
Resolution to nearest impurityvs [D-Trp]-epimer0.89no 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.

0333966771001613355 Kisspeptin-109.61 min · 98.96 % 9.01 same trace · ×50 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 05101520253035 Retention time (min) Response (mAU)
Figure 1. RP-HPLC trace, 32 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 75,343, 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 0.69 % impurity against a 98.96 % 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 peak9.614,809,76398.96
2des-Tyr (−163 Da)9.0133,5360.69-163.063
3C-terminal free acid (+1 Da)9.8011,1790.23+0.984
4oxidised Trp (+16 Da)9.253,4020.07+15.995
5[D-Trp]-epimer9.482,4300.050.000
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, high-resolution instrument. Sticks are placed at m/z = (M + z × 1.007276)/z for the observed neutral mass of 1301.6261 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+434.8839434.8826-0.00137.8
2+651.8223651.8203-0.002058.7
1+1302.63731302.6334-0.0039100.0
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.

ComponentDetermination%w/w of cake
WaterKarl Fischer6.32
Counter-ion (acetate)ion chromatography4.21
Residual solvent + inorganic residueestimated0.45
Total peptide contentby difference89.02
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)99.8898.96divergence +0.02 pp vs batch median
Total impurities (% area)0.121.04
Largest single impurity (% area)0.080.69
Water (%)not stated6.32
Counter-ion (%)not stated4.21
Peptide content (%w/w)91.789.02
Endotoxin (EU/mg)0.10not 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
Domestic warehouse despatch → submitter (2–8 °C, 11 d) → laboratory (courier, cold pack, 4 d) → assay.
Assay date
20 Jun 2024
Submitted to the index
15 Jul 2024
Laboratory
VendorInvestigate, Riga, Latvia
Method basis
32 min gradient · high-resolution MS
Verification status
VERIFIED
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-2024-004184WWB-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-2024-004188WWB-2311-T3203Medutest2024-Q299.935.93Supplier-supplied1MARGINAL
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