AX-2026-041835 · Survodutide · GSP lot GSP-2603-E3156

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, 35 min gradient, 214 nm	98.34	% area	≥ 96.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	1.66	% area	≤ 3.5	PASS
Largest single impurity	RP-HPLC — truncated (2-39)	1.04	% area	≤ 1.00	FAIL
Identity — theoretical monoisotopic mass	calculated from molecular formula	4764.5121	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, high resolution (ESI-TOF/QTOF)	4764.5040	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	-1.7	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	84.79	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	83.38	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	10.67	mg	10 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	8.897	mg	10 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	89.0	%	90.0 – 110.0	FAIL
Water content	Karl Fischer, coulometric, duplicate	5.74	%	≤ 8.0	PASS
Counter-ion (TFA)	anion-exchange ion chromatography	8.64	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.83	%	—	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 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	3.76	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 35 min gradient	23.42	min	23.23 ± 0.50 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.02	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	40,643	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [D-Ser2]-diastereomer	0.64	—	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 40,643, and skew follows the reported asymmetry factor of 1.02. 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 1.04 % impurity against a 98.34 % 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	23.42	4,779,629	98.34	—
2	truncated (2-39)	21.83	50,547	1.04	-137.059
3	[D-Ser2]-diastereomer	23.12	14,095	0.29	0.000
4	aspartimide (−18 Da)	24.14	8,749	0.18	-18.011
5	C18 diacid mono-ester	25.10	3,888	0.08	+14.016
6	des-γGlu linker (−129 Da)	22.31	1,944	0.04	-129.043
7	survodutide dimer	28.15	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 4764.5040 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	681.6507	-0.0012	8.2
6+	795.0926	795.0913	-0.0013	54.1
5+	953.9097	953.9081	-0.0016	100.0
4+	1192.1353	1192.1333	-0.0020	52.4
3+	1589.1780	1589.1753	-0.0027	8.7

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	5.74
Counter-ion (TFA)	ion chromatography	8.64
Residual solvent + inorganic residue	estimated	0.83
Total peptide content	by difference	84.79
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)	98.79	98.34	divergence +0.47 pp vs batch median
Total impurities (% area)	not stated	1.66
Largest single impurity (% area)	not stated	1.04
Water (%)	not stated	5.74
Counter-ion (%)	2.7	8.64
Peptide content (%w/w)	98.4	84.79
Endotoxin (EU/mg)	not stated	not determined
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: Retail purchase → submitter (ambient, 11 d) → laboratory (courier, cold pack, 12 d) → assay.
Assay date: 20 Aug 2026
Submitted to the index: 27 Aug 2026
Laboratory: Nordanalyt Laboratories, Uppsala, Sweden
Method basis: 35 min gradient · high-resolution MS
Verification status: VERIFIED

What this report does not establish

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.

nmr_qnmr27 Aug 2026

Mass at -1.7 ppm establishes identity but not content. Absolute content needs a standard or an orthogonal quantitative method, and neither is a mass spectrometer.

hplc_ola27 Aug 2026

Purity 98.34 % with truncated (2-39) at 1.04 % nearby. Read the pair together: the purity figure and its nearest neighbour are two views of one integration decision.

c18_2p627 Aug 2026

Doubling column length gains 40 % resolution and doubles the run. On a routine release method that trade is usually declined, and the certificate should say which method was run.

Section 7

Related records

Same batch — lot GSP-2603-E3156 n=8

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2026-041831	GSP-2603-E3156	Kestrel	2026-Q3	99.91	5.50	93.2	Buyer-sourced	PASS
AX-2026-041832	GSP-2603-E3156	VendorInvestigate	2026-Q3	98.01	5.14	99.5	Buyer-sourced	PASS
AX-2026-041833	GSP-2603-E3156	Janoshik	2026-Q3	98.08	4.91	99.3	Buyer-sourced	PASS
AX-2026-041834	GSP-2603-E3156	VendorInvestigate	2026-Q3	97.92	5.95	—	Buyer-sourced	PASS
AX-2026-041836	GSP-2603-E3156	Janoshik	2026-Q3	98.65	5.34	90.3	Buyer-sourced	PASS
AX-2026-041837	GSP-2603-E3156	Janoshik	2026-Q3	98.33	5.37	—	Buyer-sourced	PASS
AX-2026-041838	GSP-2603-E3156	PeptideMeter	2026-Q3	98.30	5.01	102.4	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	Result
AX-2026-041831	GSP	GSP-2603-E3156	Kestrel	2026-Q3	99.91	5.50	93.2	Buyer-sourced	PASS
AX-2026-042706	ERP	ERP-2605-E9865	PeptideMeter	2026-Q3	98.38	5.33	103.5	Buyer-sourced	PASS
AX-2026-041836	GSP	GSP-2603-E3156	Janoshik	2026-Q3	98.65	5.34	90.3	Buyer-sourced	PASS
AX-2026-041837	GSP	GSP-2603-E3156	Janoshik	2026-Q3	98.33	5.37	—	Buyer-sourced	PASS
AX-2026-041833	GSP	GSP-2603-E3156	Janoshik	2026-Q3	98.08	4.91	99.3	Buyer-sourced	PASS
AX-2026-041832	GSP	GSP-2603-E3156	VendorInvestigate	2026-Q3	98.01	5.14	99.5	Buyer-sourced	PASS
AX-2026-041834	GSP	GSP-2603-E3156	VendorInvestigate	2026-Q3	97.92	5.95	—	Buyer-sourced	PASS
AX-2026-041838	GSP	GSP-2603-E3156	PeptideMeter	2026-Q3	98.30	5.01	102.4	Buyer-sourced	PASS

Other recent GSP records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2026-041831	Survodutide	GSP-2603-E3156	Kestrel	2026-Q3	99.91	5.50	93.2	Buyer-sourced	PASS
AX-2026-041836	Survodutide	GSP-2603-E3156	Janoshik	2026-Q3	98.65	5.34	90.3	Buyer-sourced	PASS
AX-2026-041837	Survodutide	GSP-2603-E3156	Janoshik	2026-Q3	98.33	5.37	—	Buyer-sourced	PASS
AX-2026-041833	Survodutide	GSP-2603-E3156	Janoshik	2026-Q3	98.08	4.91	99.3	Buyer-sourced	PASS
AX-2026-041832	Survodutide	GSP-2603-E3156	VendorInvestigate	2026-Q3	98.01	5.14	99.5	Buyer-sourced	PASS
AX-2026-041834	Survodutide	GSP-2603-E3156	VendorInvestigate	2026-Q3	97.92	5.95	—	Buyer-sourced	PASS
AX-2026-041838	Survodutide	GSP-2603-E3156	PeptideMeter	2026-Q3	98.30	5.01	102.4	Buyer-sourced	PASS
AX-2026-041824	Semaglutide	GSP-2512-H2838	Janoshik	2026-Q2	98.87	5.26	96.4	Buyer-sourced	PASS