AX-2026-042832 · Survodutide · GGPeps lot GGPE-2512-Y2660

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, 15 min gradient, 214 nm	98.68	% area	≥ 96.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	1.32	% area	≤ 3.5	PASS
Largest single impurity	RP-HPLC — truncated (2-39)	0.49	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	4764.5121	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, unit resolution (single quadrupole)	4764.4282	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	-17.6	ppm	± 15	FAIL
Total peptide content	by difference from the gravimetric mass balance	90.15	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	88.96	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	15.52	mg	15 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	13.807	mg	15 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	92.0	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	3.59	%	≤ 8.0	PASS
Counter-ion (TFA)	anion-exchange ion chromatography	6.03	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.23	%	—	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 to pale-yellow 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	3.49	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 15 min gradient	10.81	min	10.88 ± 0.50 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.23	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	55,567	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [D-Ser2]-diastereomer	0.69	—	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, 15 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 55,567, and skew follows the reported asymmetry factor of 1.23. 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 0.49 % impurity against a 98.68 % 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	10.81	4,796,154	98.68	—
2	truncated (2-39)	10.13	23,816	0.49	-137.059
3	[D-Ser2]-diastereomer	10.68	22,843	0.47	0.000
4	des-γGlu linker (−129 Da)	10.34	7,290	0.15	-129.043
5	aspartimide (−18 Da)	11.12	5,832	0.12	-18.011
6	C18 diacid mono-ester	11.53	3,402	0.07	+14.016
7	survodutide dimer	12.84	972	0.02	+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, unit-resolution instrument. Sticks are placed at m/z = (M + z × 1.007276)/z for the observed neutral mass of 4764.4282 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	681.6399	-0.0120	8.0
6+	795.0926	795.0786	-0.0140	51.4
5+	953.9097	953.8929	-0.0168	100.0
4+	1192.1353	1192.1143	-0.0210	52.7
3+	1589.1780	1589.1500	-0.0280	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	3.59
Counter-ion (TFA)	ion chromatography	6.03
Residual solvent + inorganic residue	estimated	0.23
Total peptide content	by difference	90.15
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)	97.46	98.68	divergence -0.20 pp vs batch median
Total impurities (% area)	1.63	1.32
Largest single impurity (% area)	2.54	0.49
Water (%)	not stated	3.59
Counter-ion (%)	not stated	6.03
Peptide content (%w/w)	91.7	90.15
Endotoxin (EU/mg)	0.72	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: Laboratory-retained
Evidentiary weight: Provenance documented, selection uncontrolled.
Chain of custody: Laboratory retained sample (−20 °C, 14 d since original receipt) → re-assay.
Assay date: 08 May 2026
Submitted to the index: 18 May 2026
Laboratory: Kestrel Bioanalytical, Melbourne, Australia
Method basis: 15 min gradient · unit-resolution MS
Verification status: METHOD LIMITED

What this report does not establish

That the compound is not a near-isobaric alternative. Identity was confirmed at unit mass resolution, which cannot exclude species differing by 1 or 2 Da. The specific alternatives not excluded are named in the identity block above.
That mass-identical impurities are absent. The gradient used is shorter than the index reference method and does not resolve the diastereomers named in the compound fingerprint. The purity figure is an upper bound.
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 4

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.

mass_defect18 May 2026

If the assignment is shifted by one charge state the error resolves. Confirm the deconvolution before treating -17.6 ppm as a real discrepancy about the material.

ppm_error18 May 2026

The distribution of ppm error by instrument class in this index is wide enough that a single figure like -17.6 ppm carries little on its own. What carries is whether the same instrument produced similar excursions on adjacent runs, and the laboratory page has that.

sodium_adduct18 May 2026

The index records this as identity not established. That is a statement about the evidence, not about the material, and the distinction is the whole reason the status vocabulary has four values instead of two.

c18_2p618 May 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 GGPE-2512-Y2660 n=14

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042831	GGPE-2512-Y2660	Janoshik	2026-Q2	97.68	3.56	—	Buyer-sourced	2	MARGINAL
AX-2026-042833	GGPE-2512-Y2660	PeptideMeter	2026-Q2	97.44	3.46	93.3	Buyer-sourced	2	MARGINAL
AX-2026-042834	GGPE-2512-Y2660	Janoshik	2026-Q2	97.65	3.87	88.9	Buyer-sourced	3	MARGINAL
AX-2026-042835	GGPE-2512-Y2660	Janoshik	2026-Q2	97.77	4.16	—	Buyer-sourced	2	MARGINAL
AX-2026-042836	GGPE-2512-Y2660	Janoshik	2026-Q2	97.60	2.83	—	Buyer-sourced	2	MARGINAL
AX-2026-042837	GGPE-2512-Y2660	Janoshik	2026-Q2	97.63	3.04	—	Buyer-sourced	2	MARGINAL
AX-2026-042838	GGPE-2512-Y2660	Janoshik	2026-Q2	97.69	3.50	—	Buyer-sourced	2	MARGINAL
AX-2026-042839	GGPE-2512-Y2660	Janoshik	2026-Q2	97.37	3.92	95.0	Buyer-sourced	2	MARGINAL
AX-2026-042840	GGPE-2512-Y2660	PeptideMeter	2026-Q2	97.67	3.80	101.8	Buyer-sourced	2	MARGINAL
AX-2026-042841	GGPE-2512-Y2660	Janoshik	2026-Q2	97.71	3.99	—	Buyer-sourced	2	MARGINAL
AX-2026-042842	GGPE-2512-Y2660	Janoshik	2026-Q2	97.63	4.13	—	Buyer-sourced	2	MARGINAL
AX-2026-042843	GGPE-2512-Y2660	Nordanalyt	2026-Q2	97.37	3.00	—	Buyer-sourced	2	MARGINAL
AX-2026-042844	GGPE-2512-Y2660	Janoshik	2026-Q2	98.41	4.02	—	Supplier-supplied	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 GGPeps records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2026-042784	CJC-1295 (no DAC)	GGPE-2606-E1234	Medutest	2026-Q3	98.27	4.55	—	Buyer-sourced	PASS
AX-2026-042786	CJC-1295 (no DAC)	GGPE-2606-E1234	Janoshik	2026-Q3	98.22	3.77	—	Buyer-sourced	PASS
AX-2026-042858	Selank	GGPE-2603-J2447	VendorInvestigate	2026-Q3	98.87	8.85	99.4	Buyer-sourced	FAIL
AX-2026-042783	CJC-1295 (no DAC)	GGPE-2606-E1234	Janoshik	2026-Q3	98.22	4.45	90.6	Buyer-sourced	PASS
AX-2026-042757	Melanotan II	GGPE-2603-P1474	Janoshik	2026-Q3	99.54	6.78	92.0	Buyer-sourced	PASS
AX-2026-042785	CJC-1295 (no DAC)	GGPE-2606-E1234	PeptideMeter	2026-Q3	97.70	4.64	91.4	Buyer-sourced	FAIL
AX-2026-042756	Melanotan II	GGPE-2603-P1474	Nordanalyt	2026-Q3	99.17	7.04	—	Buyer-sourced	PASS
AX-2026-042755	Melanotan II	GGPE-2603-P1474	Nordanalyt	2026-Q3	99.25	6.58	90.4	Buyer-sourced	PASS