AX-2025-020911 · Survodutide · WXT lot WXT-2501-X2463

Section 1

Results

Measured against the index acceptance specification for the incretin analogues and co-agonists 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, 25 min gradient, 214 nm	98.04	% area	≥ 96.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	1.96	% area	≤ 3.5	PASS
Largest single impurity	RP-HPLC — [D-Ser2]-diastereomer	1.36	% area	≤ 1.00	FAIL
Identity	not ordered on this submission	not determined	—	required for VERIFIED status	NOT TESTED
Total peptide content	by difference from the gravimetric mass balance	90.32	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	88.55	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	15.37	mg	15 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	13.610	mg	15 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	90.7	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	3.77	%	≤ 8.0	PASS
Counter-ion (TFA)	anion-exchange ion chromatography	5.41	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.50	%	—	NOT TESTED
Endotoxin	not ordered on this submission	not determined	—	≤ 5.0	NOT TESTED
Sterility	not ordered on this submission	not determined	—	no growth	NOT TESTED
Appearance	visual, diffuse light, black and white background	White cake, partial shrinkage from vial wall	—	white to off-white intact cake	FAIL
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	3.71	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 25 min gradient	16.98	min	17.05 ± 0.50 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.17	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	52,785	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [D-Ser2]-diastereomer	0.72	—	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, 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 52,785, and skew follows the reported asymmetry factor of 1.17. 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 1.36 % impurity against a 98.04 % 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	Survodutide — main peak	16.98	4,765,048	98.04	—
2	[D-Ser2]-diastereomer	16.76	66,100	1.36	0.000
3	aspartimide (−18 Da)	17.50	19,441	0.40	-18.011
4	des-γGlu linker (−129 Da)	16.19	5,346	0.11	-129.043
5	survodutide dimer	20.36	1,944	0.04	+4764.512
6	truncated (2-39)	15.85	1,944	0.04	-137.059
7	C18 diacid mono-ester	18.18	486	0.01	+14.016
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.

Component	Determination	%w/w of cake
Water	Karl Fischer	3.77
Counter-ion (TFA)	ion chromatography	5.41
Residual solvent + inorganic residue	estimated	0.50
Total peptide content	by difference	90.32
Total		100.00 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.

Figure	Supplier COA	This report	Index note
Purity (% area)	97.64	98.04	divergence -0.23 pp vs batch median
Total impurities (% area)	1.40	1.96
Largest single impurity (% area)	2.36	1.36
Water (%)	3.3	3.77
Counter-ion (%)	9.2	5.41
Peptide content (%w/w)	86.9	90.32
Endotoxin (EU/mg)	not stated	not determined
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, 21 d) → laboratory (courier, cold pack, 2 d) → assay.
Assay date: 23 Apr 2025
Submitted to the index: 04 May 2025
Laboratory: Medutest, Ljubljana, Slovenia
Method basis: 25 min gradient · unit-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.
That the material is free of bacterial endotoxin. Endotoxin was not measured. No chromatographic result bears on it.
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 3

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.

selection_bias04 May 2025

Provenance handles supplier selection. It does not handle submitter selection, which is the larger confounder and the one the index cannot measure.

buyer_sourced04 May 2025

No relationship between submitter and supplier is declared on this record, and the contributor register holds none. That is the default and it is what the provenance class asserts.

uncertainty_budget04 May 2025

Integration boundary on a close pair contributes up to 0.45 pp of standard uncertainty on its own. That is the term to quote alongside 98.04 % rather than a resolution verdict.

Section 7

Related records

Same batch — lot WXT-2501-X2463 n=10

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-020910	WXT-2501-X2463	Janoshik	2025-Q2	97.85	4.32	—	Buyer-sourced	2	MARGINAL
AX-2025-020912	WXT-2501-X2463	Janoshik	2025-Q2	97.89	4.15	—	Buyer-sourced	2	MARGINAL
AX-2025-020913	WXT-2501-X2463	PeptideMeter	2025-Q2	98.51	4.13	—	Buyer-sourced	2	MARGINAL
AX-2025-020914	WXT-2501-X2463	PeptideMeter	2025-Q2	97.95	4.26	93.0	Buyer-sourced	2	MARGINAL
AX-2025-020915	WXT-2501-X2463	Janoshik	2025-Q2	97.74	3.79	93.3	Buyer-sourced	2	MARGINAL
AX-2025-020916	WXT-2501-X2463	Janoshik	2025-Q2	97.79	4.51	—	Buyer-sourced	2	MARGINAL
AX-2025-020917	WXT-2501-X2463	Nordanalyt	2025-Q2	98.32	3.83	98.1	Supplier-supplied	2	MARGINAL
AX-2025-020918	WXT-2501-X2463	Medutest	2025-Q2	97.66	4.18	94.7	Supplier-supplied	3	MARGINAL
AX-2025-020919	WXT-2501-X2463	Janoshik	2025-Q2	97.79	3.88	94.0	Buyer-sourced	2	MARGINAL

Batch rollup and reproducibility assessment →

Cross-sections

Other recent Survodutide records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041831	GSP	GSP-2603-E3156	Kestrel	2026-Q3	99.91	5.50	93.2	Buyer-sourced	0	PASS
AX-2026-042706	ERP	ERP-2605-E9865	PeptideMeter	2026-Q3	98.38	5.33	103.5	Buyer-sourced	0	PASS
AX-2026-041836	GSP	GSP-2603-E3156	Janoshik	2026-Q3	98.65	5.34	90.3	Buyer-sourced	0	PASS
AX-2026-041837	GSP	GSP-2603-E3156	Janoshik	2026-Q3	98.33	5.37	—	Buyer-sourced	0	PASS
AX-2026-041833	GSP	GSP-2603-E3156	Janoshik	2026-Q3	98.08	4.91	99.3	Buyer-sourced	0	PASS
AX-2026-041832	GSP	GSP-2603-E3156	VendorInvestigate	2026-Q3	98.01	5.14	99.5	Buyer-sourced	0	PASS
AX-2026-041835	GSP	GSP-2603-E3156	Nordanalyt	2026-Q3	98.34	5.74	89.0	Buyer-sourced	1	MARGINAL
AX-2026-041834	GSP	GSP-2603-E3156	VendorInvestigate	2026-Q3	97.92	5.95	—	Buyer-sourced	0	PASS

Other recent WXT records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043376	Semaglutide	WXT-2604-C3248	Janoshik	2026-Q3	97.08	4.22	—	Buyer-sourced	1	MARGINAL
AX-2026-043429	L-Glutathione (reduced)	WXT-2605-B3833	Nordanalyt	2026-Q3	98.48	6.58	96.9	Supplier-supplied	1	FAIL
AX-2026-043347	Leuprolide	WXT-2604-K2596	PeptideMeter	2026-Q3	99.16	5.99	93.6	Buyer-sourced	0	PASS
AX-2026-043353	Leuprolide	WXT-2604-K2596	Janoshik	2026-Q3	99.19	4.90	95.3	Laboratory-retained	0	PASS
AX-2026-043345	Leuprolide	WXT-2604-K2596	Janoshik	2026-Q3	98.93	5.28	—	Buyer-sourced	0	PASS
AX-2026-043424	L-Glutathione (reduced)	WXT-2605-B3833	PeptideMeter	2026-Q3	98.37	6.86	—	Buyer-sourced	0	FAIL
AX-2026-043374	Semaglutide	WXT-2604-C3248	Janoshik	2026-Q3	97.00	3.56	—	Buyer-sourced	1	MARGINAL
AX-2026-043377	Semaglutide	WXT-2604-C3248	PeptideMeter	2026-Q3	97.20	4.08	—	Buyer-sourced	1	MARGINAL