AX-2026-041255

Survodutide · 5 mg declared · Wuhan Wansheng Biotechnology Co., Ltd. · lot WWB-2510-R2141

MARGINALVERIFIED

Report ID: AX-2026-041255
Compound: Survodutide
Compound class: Incretin analogues and co-agonists
Supplier: WWB — Wuhan Wansheng Biotechnology Co., Ltd.
Batch / lot: WWB-2510-R2141
Declared label claim: 5mg
Laboratory: Janoshik Analytical
Assay date: 07 Jan 2026
Submitted: 02 Feb 2026
Quarter: 2026-Q1
Submitter: e.salgado
Sample provenance: Supplier-supplied

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	98.61	% area	≥ 96.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	1.39	% area	≤ 3.5	PASS
Largest single impurity	RP-HPLC — [D-Ser2]-diastereomer	0.69	% 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)	4764.5245	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+2.6	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	86.58	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	85.38	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	5.34	mg	5 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	4.559	mg	5 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	91.2	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	5.74	%	≤ 8.0	PASS
Counter-ion (TFA)	anion-exchange ion chromatography	7.13	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.55	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	0.42	EU/mg	≤ 5.0	PASS
Sterility	membrane filtration, USP <71>, 14 d	No growth at 14 d	—	no growth	PASS
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	2.91	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	20.12	min	20.14 ± 0.50 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	0.94	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	54,649	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [D-Ser2]-diastereomer	0.74	—	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 54,649, and skew follows the reported asymmetry factor of 0.94. 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 0.69 % impurity against a 98.61 % 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	20.12	4,792,752	98.61	—
2	[D-Ser2]-diastereomer	19.86	33,536	0.69	0.000
3	aspartimide (−18 Da)	20.74	21,871	0.45	-18.011
4	des-γGlu linker (−129 Da)	19.17	5,346	0.11	-129.043
5	truncated (2-39)	18.76	2,916	0.06	-137.059
6	C18 diacid mono-ester	21.56	2,430	0.05	+14.016
7	survodutide dimer	24.17	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 4764.5245 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	681.6536	0.0017	8.0
6+	795.0926	795.0947	0.0021	52.1
5+	953.9097	953.9122	0.0025	100.0
4+	1192.1353	1192.1384	0.0031	57.3
3+	1589.1780	1589.1821	0.0041	7.8

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	7.13
Residual solvent + inorganic residue	estimated	0.55
Total peptide content	by difference	86.58
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)	99.33	98.61	divergence +0.49 pp vs batch median
Total impurities (% area)	0.67	1.39
Largest single impurity (% area)	0.25	0.69
Water (%)	5.1	5.74
Counter-ion (%)	not stated	7.13
Peptide content (%w/w)	not stated	86.58
Endotoxin (EU/mg)	0.28	0.42
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: Supplier-supplied
Evidentiary weight: Weaker evidence. Read with the caveat below.
Chain of custody: Supplier despatch → laboratory direct (courier, cold pack, 10 d) → assay. Submitter did not handle the vial.
Assay date: 07 Jan 2026
Submitted to the index: 02 Feb 2026
Laboratory: Janoshik Analytical, Ostrava, Czechia
Method basis: 30 min gradient · high-resolution MS
Verification status: VERIFIED

Section 6

Annotations

No annotations on this record. Annotations are short signed technical comments from index contributors; see how to contribute.

Section 7

Related records

Same batch — lot WWB-2510-R2141 n=2

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041254	WWB-2510-R2141	VendorInvestigate	2026-Q1	99.06	5.79	106.9	Buyer-sourced	1	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-2026-042547	ERP	ERP-2605-E7682	PeptideMeter	2026-Q3	98.25	5.44	93.0	Supplier-supplied	1	MARGINAL
AX-2026-042548	ERP	ERP-2605-E7682	Janoshik	2026-Q3	97.92	5.96	92.8	Supplier-supplied	1	MARGINAL
AX-2026-042546	ERP	ERP-2605-E7682	Janoshik	2026-Q3	98.01	5.78	105.0	Supplier-supplied	1	MARGINAL
AX-2026-042549	ERP	ERP-2605-E7682	Janoshik	2026-Q3	98.73	5.51	91.2	Supplier-supplied	1	MARGINAL
AX-2026-042728	GGPeps	GGPE-2512-Y9921	PeptideMeter	2026-Q2	97.83	4.12	98.6	Supplier-supplied	1	MARGINAL
AX-2026-042730	GGPeps	GGPE-2512-Y9921	PeptideMeter	2026-Q2	97.74	3.68	—	Supplier-supplied	1	MARGINAL
AX-2026-042729	GGPeps	GGPE-2512-Y9921	Janoshik	2026-Q2	97.37	3.51	99.0	Laboratory-retained	1	MARGINAL
AX-2026-042727	GGPeps	GGPE-2512-Y9921	Nordanalyt	2026-Q2	97.45	3.38	—	Supplier-supplied	1	MARGINAL

Other recent WWB records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041275	Liraglutide	WWB-2607-X2189	Nordanalyt	2026-Q3	99.61	5.03	97.3	Supplier-supplied	0	PASS
AX-2026-041387	BPC-157	WWB-2606-H3906	Janoshik	2026-Q3	98.95	4.64	—	Laboratory-retained	1	MARGINAL
AX-2026-041334	Semaglutide	WWB-2606-N3192	Janoshik	2026-Q3	98.83	5.04	—	Supplier-supplied	1	MARGINAL
AX-2026-041337	Semaglutide	WWB-2606-N3192	Nordanalyt	2026-Q3	98.96	4.81	—	Supplier-supplied	1	MARGINAL
AX-2026-041385	BPC-157	WWB-2606-H3906	Medutest	2026-Q3	99.31	4.31	—	Supplier-supplied	1	MARGINAL
AX-2026-041390	BPC-157	WWB-2606-H3906	Medutest	2026-Q3	99.47	4.84	99.3	Supplier-supplied	1	MARGINAL
AX-2026-041386	BPC-157	WWB-2606-H3906	VendorInvestigate	2026-Q3	99.32	4.88	99.2	Buyer-sourced	1	MARGINAL
AX-2026-041335	Semaglutide	WWB-2606-N3192	Janoshik	2026-Q3	99.55	4.55	100.5	Supplier-supplied	1	MARGINAL