AX-2025-019834 · Survodutide · Homopeptide lot HOMO-2406-F5091

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, 30 min gradient, 214 nm	99.70	% area	≥ 96.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.30	% area	≤ 3.5	PASS
Largest single impurity	RP-HPLC — [D-Ser2]-diastereomer	0.12	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	4764.5121	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, high resolution (ESI-TOF/QTOF)	4764.5116	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	-0.1	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	88.60	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	88.33	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	5.46	mg	5 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	4.823	mg	5 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	96.5	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	4.86	%	≤ 8.0	PASS
Counter-ion (TFA)	anion-exchange ion chromatography	5.74	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.80	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	0.26	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 powder, no defined cake (melt-back)	—	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	4.56	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	20.00	min	20.14 ± 0.50 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.06	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	55,660	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [D-Ser2]-diastereomer	0.75	—	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 55,660, and skew follows the reported asymmetry factor of 1.06. 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 0.12 % impurity against a 99.70 % 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	20.00	4,845,729	99.70	—
2	[D-Ser2]-diastereomer	19.74	5,832	0.12	0.000
3	des-γGlu linker (−129 Da)	19.05	5,832	0.12	-129.043
4	C18 diacid mono-ester	21.44	1,458	0.03	+14.016
5	survodutide dimer	24.05	1,458	0.03	+4764.512
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 4764.5121 Da, computed from C220H340N50O67. 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 4764.5116 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 (%)
7+	681.6519	681.6518	-0.0001	9.1
6+	795.0926	795.0925	-0.0001	61.8
5+	953.9097	953.9096	-0.0001	100.0
4+	1192.1353	1192.1352	-0.0001	53.7
3+	1589.1780	1589.1778	-0.0002	8.3

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	4.86
Counter-ion (TFA)	ion chromatography	5.74
Residual solvent + inorganic residue	estimated	0.80
Total peptide content	by difference	88.60
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)	99.52	99.70	divergence +0.17 pp vs batch median
Total impurities (% area)	not stated	0.30
Largest single impurity (% area)	not stated	0.12
Water (%)	2.8	4.86
Counter-ion (%)	not stated	5.74
Peptide content (%w/w)	92.4	88.60
Endotoxin (EU/mg)	not stated	0.26
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: Retail purchase → third-party forwarder (6 d) → laboratory (courier, cold pack, 10 d) → assay.
Assay date: 15 Dec 2024
Submitted to the index: 04 Jan 2025
Laboratory: Janoshik Analytical, Ostrava, Czechia
Method basis: 30 min gradient · high-resolution MS
Verification status: VERIFIED

What this report does not establish

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.

median_not_mean04 Jan 2025

One result at the top of the distribution should not move anybody's estimate much on its own. Purity distributions are compressed at the top and long-tailed at the bottom, so the informative observations are the low ones.

ms_confirm04 Jan 2025

Identity confirmed and purity at 99.70 %. The two answer different questions — what it is, and how much else is in it — and a record carrying both is the version worth citing.

Section 7

Related records

Same batch — lot HOMO-2406-F5091 n=14

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2024-004756	HOMO-2406-F5091	Janoshik	2024-Q4	99.24	5.12	—	Buyer-sourced	PASS
AX-2024-004757	HOMO-2406-F5091	Janoshik	2024-Q4	99.42	5.35	95.9	Buyer-sourced	PASS
AX-2024-004758	HOMO-2406-F5091	Janoshik	2024-Q4	99.39	4.83	98.4	Buyer-sourced	PASS
AX-2024-004759	HOMO-2406-F5091	PeptideMeter	2024-Q4	99.93	4.15	98.1	Supplier-supplied	PASS
AX-2024-004760	HOMO-2406-F5091	PeptideMeter	2024-Q4	99.09	4.41	100.4	Buyer-sourced	PASS
AX-2024-004761	HOMO-2406-F5091	VendorInvestigate	2024-Q4	99.19	4.48	91.3	Buyer-sourced	PASS
AX-2024-004762	HOMO-2406-F5091	Medutest	2024-Q4	99.44	5.10	—	Buyer-sourced	PASS
AX-2025-019832	HOMO-2406-F5091	Nordanalyt	2024-Q4	99.14	4.78	—	Buyer-sourced	PASS
AX-2025-019833	HOMO-2406-F5091	PeptideMeter	2024-Q4	99.32	5.17	99.3	Buyer-sourced	PASS
AX-2024-004763	HOMO-2406-F5091	PeptideMeter	2024-Q4	99.01	4.84	93.6	Buyer-sourced	PASS
AX-2024-004764	HOMO-2406-F5091	Janoshik	2024-Q4	99.74	4.81	92.8	Buyer-sourced	PASS
AX-2024-004765	HOMO-2406-F5091	Nordanalyt	2024-Q4	99.47	4.88	95.2	Buyer-sourced	PASS
AX-2024-004766	HOMO-2406-F5091	Medutest	2024-Q4	99.17	4.78	—	Buyer-sourced	PASS

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 Homopeptide records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2026-042437	Retatrutide	HOMO-2605-V4718	Nordanalyt	2026-Q3	98.68	3.67	102.8	Buyer-sourced	PASS
AX-2026-042424	Semaglutide	HOMO-2604-X3806	PeptideMeter	2026-Q3	98.85	4.87	92.0	Buyer-sourced	PASS
AX-2026-042503	IGF-1 LR3	HOMO-2607-P5131	Janoshik	2026-Q3	99.36	5.99	—	Buyer-sourced	PASS
AX-2026-042492	SS-31 (Elamipretide)	HOMO-2604-D5484	Medutest	2026-Q3	99.93	2.40	—	Buyer-sourced	PASS
AX-2026-042491	SS-31 (Elamipretide)	HOMO-2604-D5484	Kestrel	2026-Q3	99.93	3.24	—	Supplier-supplied	PASS
AX-2026-042473	LL-37	HOMO-2602-G5165	Janoshik	2026-Q3	99.01	5.00	—	Buyer-sourced	PASS
AX-2026-042441	Retatrutide	HOMO-2605-V4718	Medutest	2026-Q3	98.93	4.22	—	Buyer-sourced	PASS
AX-2026-042474	LL-37	HOMO-2602-G5165	Janoshik	2026-Q3	99.18	5.44	—	Buyer-sourced	PASS