AX-2024-004189

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

PASSVERIFIED

Report ID: AX-2024-004189
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: Janoshik Analytical
Assay date: 11 Jun 2024
Submitted: 02 Jul 2024
Quarter: 2024-Q2
Submitter: c.kuipers
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.

Parameter	Method	Result	Unit	Index spec
Purity	RP-HPLC, 30 min gradient, 214 nm	99.92	% area	≥ 98.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.08	% area	≤ 1.5	PASS
Largest single impurity	RP-HPLC — des-Tyr (−163 Da)	0.05	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	1301.6300	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, high resolution (ESI-TOF/QTOF)	1301.6305	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+0.4	ppm	± 15	PASS
Peptide content	not ordered on this submission	not determined	—	required to check label claim	NOT TESTED
Water content	Karl Fischer, coulometric, duplicate	6.38	%	≤ 8.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	3.91	%	≤ 10.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.23	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	0.24	EU/mg	≤ 5.0	PASS
Sterility	not ordered on this submission	not determined	—	no growth	NOT TESTED
Appearance	visual, diffuse light, black and white background	Off-white lyophilised cake, intact	—	white to off-white intact cake	PASS
Reconstitution clarity	reconstituted per submitter procedure	Faint haze, clearing on standing	—	clear, no visible particulates	FAIL
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	5.31	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	9.07	min	9.14 ± 0.25 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	0.94	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	52,990	—	≥ 20,000	PASS
Resolution to nearest impurity	vs C-terminal free acid (+1 Da)	1.11	—	no index criterion	REPORTED

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.

Figure 1. RP-HPLC trace, 30 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 52,990, and skew follows the reported asymmetry factor of 0.94. 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 99.92 % main peak is a line two pixels tall; the main peak runs off-scale there by design.

#	Peak	RT	Area (µV·s)	% area	Δ mass (Da)
1	Kisspeptin-10 — main peak	9.07	4,856,422	99.92	—
2	des-Tyr (−163 Da)	8.51	2,430	0.05	-163.063
3	C-terminal free acid (+1 Da)	9.25	972	0.02	+0.984
4	oxidised Trp (+16 Da)	8.73	486	0.01	+15.995
Closure check — purity + Σ impurities				100.00	CLOSES

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.

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 1301.6305 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.

Charge	Theoretical m/z	Observed m/z	Δ m/z	Rel. abundance (%)
3+	434.8839	434.8841	0.0002	8.8
2+	651.8223	651.8225	0.0002	54.4
1+	1302.6373	1302.6378	0.0005	100.0

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.

Figure	Supplier COA	This report	Index note
Purity (% area)	99.33	99.92	divergence -0.59 pp vs batch median
Total impurities (% area)	0.67	0.08
Largest single impurity (% area)	not stated	0.05
Water (%)	3.9	6.38
Counter-ion (%)	not stated	3.91
Peptide content (%w/w)	91.3	not determined
Endotoxin (EU/mg)	0.10	0.24
Method stated on certificate	YES	—	column, 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, 5 d) → laboratory (courier, cold pack, 11 d) → assay.
Assay date: 11 Jun 2024
Submitted to the index: 02 Jul 2024
Laboratory: Janoshik Analytical, Ostrava, Czechia
Method basis: 30 min gradient · high-resolution MS
Verification status: VERIFIED

What this report does not establish

How much of the named compound is in the vial. Peptide content was not determined, so recovered mass cannot be calculated and the label claim cannot be checked.
That the material is sterile. Sterility was not tested.
That any other vial in the same lot has the same composition. One vial was tested. Within-lot vial-to-vial variation in this index has a median of 0.28 pp and a 90th percentile of 0.74 pp.
That any other lot from the same supplier has the same composition. Batch-to-batch variation is larger than within-batch variation for every supplier here.
That the material is suitable for administration to a human or an animal. These are research compounds. No result on this site is a safety assessment and the index takes no position on use.
That the material was manufactured by the supplier that sold it. Contract synthesis is normal in this market and twenty-nine batches in the index fingerprint to a bulk from a different company than the one named on the label.

Section 6

Annotations 2

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.

racemisation_ala02 Jul 2024

Epimerisation during activation produces a diastereomer that is mass-identical and only chromatographically separable. At this gradient length the separation exists, and 99.92 % is net of it.

ppm_error02 Jul 2024

Mass, retention and impurity profile all agree on this record. Three independent constraints pointing the same way is the strongest identity evidence the index publishes.

Section 7

Related records

Same batch — lot WWB-2311-T3203 n=13

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2024-004183	WWB-2311-T3203	VendorInvestigate	2024-Q2	99.34	6.32	97.8	Buyer-sourced	PASS
AX-2024-004184	WWB-2311-T3203	Janoshik	2024-Q2	99.93	6.41	—	Buyer-sourced	PASS
AX-2024-004185	WWB-2311-T3203	Janoshik	2024-Q2	99.62	6.17	96.5	Laboratory-retained	PASS
AX-2024-004186	WWB-2311-T3203	Medutest	2024-Q2	99.93	6.68	—	Buyer-sourced	PASS
AX-2024-004187	WWB-2311-T3203	VendorInvestigate	2024-Q2	99.64	6.07	92.7	Buyer-sourced	PASS
AX-2024-004188	WWB-2311-T3203	Medutest	2024-Q2	99.93	6.19	—	Buyer-sourced	PASS
AX-2024-004190	WWB-2311-T3203	Janoshik	2024-Q2	99.71	6.51	103.3	Buyer-sourced	PASS
AX-2024-004191	WWB-2311-T3203	PeptideMeter	2024-Q2	99.90	6.53	—	Buyer-sourced	PASS
AX-2024-004192	WWB-2311-T3203	Janoshik	2024-Q2	99.93	5.79	101.4	Buyer-sourced	PASS
AX-2024-004193	WWB-2311-T3203	VendorInvestigate	2024-Q2	99.93	5.87	94.7	Buyer-sourced	PASS
AX-2024-004194	WWB-2311-T3203	Janoshik	2024-Q2	99.93	6.39	99.1	Buyer-sourced	PASS
AX-2024-004195	WWB-2311-T3203	Janoshik	2024-Q2	99.81	6.06	92.6	Buyer-sourced	PASS

Batch rollup and reproducibility assessment →

Cross-sections

Other recent Kisspeptin-10 records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043179	GL Biochem	GLBI-2608-N7715	Medutest	2026-Q3	98.97	4.37	—	Buyer-sourced	1	MARGINAL
AX-2026-043178	GL Biochem	GLBI-2608-N7715	Janoshik	2026-Q3	98.50	4.55	—	Buyer-sourced	1	MARGINAL
AX-2026-043184	GL Biochem	GLBI-2608-N7715	Janoshik	2026-Q3	98.99	3.63	100.6	Supplier-supplied	1	MARGINAL
AX-2026-043185	GL Biochem	GLBI-2608-N7715	Medutest	2026-Q3	98.71	3.71	107.0	Buyer-sourced	1	MARGINAL
AX-2026-043182	GL Biochem	GLBI-2608-N7715	Janoshik	2026-Q3	98.93	3.86	95.7	Buyer-sourced	1	MARGINAL
AX-2026-043183	GL Biochem	GLBI-2608-N7715	PeptideMeter	2026-Q3	98.54	4.17	102.2	Buyer-sourced	1	MARGINAL
AX-2026-043186	GL Biochem	GLBI-2608-N7715	Janoshik	2026-Q3	98.56	3.60	96.8	Buyer-sourced	1	MARGINAL
AX-2026-043181	GL Biochem	GLBI-2608-N7715	Janoshik	2026-Q3	98.77	4.06	95.2	Buyer-sourced	1	MARGINAL

Other recent WWB records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041275	Liraglutide	WWB-2607-X2189	Nordanalyt	2026-Q3	99.33	4.39	—	Buyer-sourced	1	MARGINAL
AX-2026-041334	Semaglutide	WWB-2606-N3192	Janoshik	2026-Q3	98.93	4.62	99.9	Buyer-sourced	0	PASS
AX-2026-041337	Semaglutide	WWB-2606-N3192	Nordanalyt	2026-Q3	99.52	3.92	—	Buyer-sourced	0	PASS
AX-2026-041335	Semaglutide	WWB-2606-N3192	Janoshik	2026-Q3	99.15	4.27	98.9	Buyer-sourced	0	PASS
AX-2026-041271	Liraglutide	WWB-2607-X2189	Medutest	2026-Q3	99.52	4.57	97.4	Buyer-sourced	1	MARGINAL
AX-2026-041328	Semaglutide	WWB-2606-N3192	Janoshik	2026-Q3	98.99	4.47	106.1	Buyer-sourced	0	PASS
AX-2026-041333	Semaglutide	WWB-2606-N3192	Janoshik	2026-Q3	99.18	4.51	90.4	Laboratory-retained	0	PASS
AX-2026-041273	Liraglutide	WWB-2607-X2189	Janoshik	2026-Q3	99.31	5.52	104.8	Buyer-sourced	1	MARGINAL