AX-2024-004411

Kisspeptin-10 · 10 mg declared · Asymchem Laboratories (Tianjin) Co., Ltd. · lot ASY-{CAT}-2919

PASSPURITY ONLY

Report ID: AX-2024-004411
Compound: Kisspeptin-10
Compound class: Melanocortin-receptor peptides
Supplier: ASY — Asymchem Laboratories (Tianjin) Co., Ltd.
Batch / lot: ASY-{CAT}-2919
Declared label claim: 10mg
Laboratory: Nordanalyt Laboratories
Assay date: 07 Nov 2024
Submitted: 01 Dec 2024
Quarter: 2024-Q4
Submitter: RT_shift
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, 35 min gradient, 214 nm	99.56	% area	≥ 98.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.44	% area	≤ 1.5	PASS
Largest single impurity	RP-HPLC — des-Tyr (−163 Da)	0.27	% area	≤ 1.00	PASS
Identity	not ordered on this submission	not determined	—	required for VERIFIED status	NOT TESTED
Peptide content	not ordered on this submission	not determined	—	required to check label claim	NOT TESTED
Water content	Karl Fischer, coulometric, duplicate	5.72	%	≤ 8.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	4.49	%	≤ 10.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.56	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	0.48	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	White lyophilised cake, intact	—	white to off-white intact cake	PASS
Reconstitution clarity	reconstituted per submitter procedure	Clear, colourless, no visible particulates	—	clear, no visible particulates	PASS
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	5.28	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 35 min gradient	10.60	min	10.54 ± 0.25 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.22	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	63,521	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [D-Trp]-epimer	0.81	—	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, 35 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 63,521, and skew follows the reported asymmetry factor of 1.22. 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 0.27 % impurity against a 99.56 % 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	10.60	4,838,925	99.56	—
2	des-Tyr (−163 Da)	9.95	13,123	0.27	-163.063
3	[D-Trp]-epimer	10.46	3,888	0.08	0.000
4	C-terminal free acid (+1 Da)	10.81	2,430	0.05	+0.984
5	oxidised Trp (+16 Da)	10.20	1,944	0.04	+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 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)	99.88	99.56	divergence +0.22 pp vs batch median
Total impurities (% area)	0.12	0.44
Largest single impurity (% area)	not stated	0.27
Water (%)	4.7	5.72
Counter-ion (%)	not stated	4.49
Peptide content (%w/w)	90.5	not determined
Endotoxin (EU/mg)	not stated	0.48
Method stated on certificate	NO	—	no 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: Domestic warehouse despatch → submitter (2–8 °C, 14 d) → laboratory (courier, cold pack, 3 d) → assay.
Assay date: 07 Nov 2024
Submitted to the index: 01 Dec 2024
Laboratory: Nordanalyt Laboratories, Uppsala, Sweden
Method basis: 35 min gradient · high-resolution MS
Verification status: PURITY ONLY

What this report does not establish

That the compound is the compound named. No identity confirmation was ordered on this submission. A purity figure describes chromatographic homogeneity of whatever eluted; it does not name it.
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.

wide_iqr01 Dec 2024

A single result at 99.56 % is one draw. What makes a supplier's process legible is the spread across its lots, and that is on the scorecard rather than here. This record is one good point in a distribution worth reading whole.

multiple_compare01 Dec 2024

Restricting every supplier comparison to buyer-sourced records is the sensitivity analysis the scorecards publish. On the current dataset it changes no ordering that was not already inside measurement noise.

Section 7

Related records

Same batch — lot ASY-{CAT}-2919 n=11

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2024-004406	ASY-{CAT}-2919	Janoshik	2024-Q4	99.32	5.40	92.4	Buyer-sourced	PASS
AX-2024-004407	ASY-{CAT}-2919	Janoshik	2024-Q4	99.18	5.17	97.3	Buyer-sourced	PASS
AX-2024-004408	ASY-{CAT}-2919	Nordanalyt	2024-Q4	99.46	5.49	91.3	Buyer-sourced	PASS
AX-2024-004409	ASY-{CAT}-2919	Medutest	2024-Q4	99.10	5.07	100.9	Buyer-sourced	PASS
AX-2024-004410	ASY-{CAT}-2919	Janoshik	2024-Q4	99.66	5.47	92.3	Buyer-sourced	PASS
AX-2025-019056	ASY-{CAT}-2919	Medutest	2024-Q4	99.93	5.85	—	Buyer-sourced	PASS
AX-2024-004412	ASY-{CAT}-2919	Medutest	2024-Q4	99.93	4.88	—	Buyer-sourced	PASS
AX-2024-004413	ASY-{CAT}-2919	VendorInvestigate	2024-Q4	99.78	5.55	—	Buyer-sourced	PASS
AX-2024-004414	ASY-{CAT}-2919	Kestrel	2024-Q4	99.93	4.83	—	Buyer-sourced	PASS
AX-2024-004415	ASY-{CAT}-2919	Medutest	2024-Q4	99.93	5.56	106.8	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 ASY records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041776	TB-500	ASY-{CAT}-2167	Janoshik	2026-Q3	99.92	4.61	98.2	Buyer-sourced	0	PASS
AX-2026-041777	TB-500	ASY-{CAT}-2167	PeptideMeter	2026-Q3	99.78	4.09	92.8	Buyer-sourced	0	PASS
AX-2026-041786	Retatrutide	ASY-{CAT}-2288	VendorInvestigate	2026-Q3	98.78	6.59	—	Buyer-sourced	0	PASS
AX-2026-041782	TB-500	ASY-{CAT}-2167	Nordanalyt	2026-Q3	99.93	3.94	—	Buyer-sourced	0	PASS
AX-2026-041793	Retatrutide	ASY-{CAT}-2288	Nordanalyt	2026-Q3	98.34	6.16	104.8	Buyer-sourced	0	PASS
AX-2026-041784	Retatrutide	ASY-{CAT}-2288	PeptideMeter	2026-Q3	98.15	6.26	91.9	Buyer-sourced	0	PASS
AX-2026-041774	TB-500	ASY-{CAT}-2167	PeptideMeter	2026-Q3	99.93	4.41	96.2	Buyer-sourced	0	PASS
AX-2026-041780	TB-500	ASY-{CAT}-2167	Janoshik	2026-Q3	99.93	3.48	102.5	Buyer-sourced	1	FAIL