AX-2025-019097 · SLU-PP-332 · GSP lot GSP-2511-C3427

Section 1

Results

Measured against the index acceptance specification for the non-peptide adjuncts 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, 28 min gradient, 214 nm	98.85	% area	≥ 98.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	1.15	% area	≤ 2.0	PASS
Largest single impurity	RP-HPLC — hydrolysed ester (+18 Da)	0.68	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	410.1300	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, high resolution (ESI-TOF/QTOF)	410.1306	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+1.5	ppm	± 10	PASS
Total peptide content	by difference from the gravimetric mass balance	92.16	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	91.10	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	10.78	mg	10 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	9.821	mg	10 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	98.2	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	7.05	%	≤ 10.0	PASS
Counter-ion	no ionisable counter-ion expected	N/A	—	not applicable	NOT TESTED
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.79	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	0.71	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	Off-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	7.99	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 28 min gradient	14.42	min	14.34 ± 0.35 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.03	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	69,278	—	≥ 20,000	PASS
Resolution to nearest impurity	vs des-methyl analogue (−14 Da)	1.50	—	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, 28 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 69,278, and skew follows the reported asymmetry factor of 1.03. 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 0.68 % impurity against a 98.85 % 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	SLU-PP-332 — main peak	14.42	4,804,416	98.85	—
2	hydrolysed ester (+18 Da)	13.26	33,050	0.68	+18.011
3	residual DMSO (process solvent)	4.99	13,609	0.28	0.000
4	des-methyl analogue (−14 Da)	14.08	5,346	0.11	-14.016
5	sulfoxide (+16 Da)	13.75	3,888	0.08	+15.995
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 410.1300 Da, computed from C22H22N2O4S. 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 410.1306 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 (%)
1+	411.1373	411.1379	0.0006	100.0

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	7.05
Counter-ion	none expected	0.00
Residual solvent + inorganic residue	estimated	0.79
Total peptide content	by difference	92.16
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)	99.07	98.85	divergence +0.06 pp vs batch median
Total impurities (% area)	0.93	1.15
Largest single impurity (% area)	not stated	0.68
Water (%)	5.2	7.05
Counter-ion (%)	4.7	N/A
Peptide content (%w/w)	96.3	92.16
Endotoxin (EU/mg)	0.45	0.71
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 → third-party forwarder (30 d) → laboratory (courier, cold pack, 10 d) → assay.
Assay date: 25 Oct 2025
Submitted to the index: 11 Nov 2025
Laboratory: PeptideMeter, Tallinn, Estonia
Method basis: 28 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.

sample_vs_retail11 Nov 2025

A retail vial at 98.85 % is worth more evidentially than a selected vial at a higher figure. That is the whole argument for recording provenance at all.

valley_drop11 Nov 2025

Valley height relative to the smaller peak is the practical criterion an operator uses, and it is not on the report. Resolution is a proxy for it and an imperfect one on asymmetric pairs.

Section 7

Related records

Same batch — lot GSP-2511-C3427 n=12

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-019089	GSP-2511-C3427	Medutest	2025-Q4	99.51	6.85	94.8	Buyer-sourced	1	MARGINAL
AX-2025-019090	GSP-2511-C3427	Janoshik	2025-Q4	98.73	6.77	107.1	Buyer-sourced	1	MARGINAL
AX-2025-019091	GSP-2511-C3427	Kestrel	2025-Q4	99.04	6.65	95.1	Buyer-sourced	1	MARGINAL
AX-2025-019092	GSP-2511-C3427	Janoshik	2025-Q4	98.95	7.35	99.0	Buyer-sourced	1	MARGINAL
AX-2025-019093	GSP-2511-C3427	Janoshik	2025-Q4	99.08	6.97	—	Buyer-sourced	1	MARGINAL
AX-2025-019094	GSP-2511-C3427	Medutest	2025-Q4	99.20	6.61	—	Buyer-sourced	1	MARGINAL
AX-2025-019095	GSP-2511-C3427	Janoshik	2025-Q4	98.79	6.57	89.6	Buyer-sourced	2	MARGINAL
AX-2025-019096	GSP-2511-C3427	PeptideMeter	2025-Q4	98.90	6.92	89.2	Buyer-sourced	2	MARGINAL
AX-2025-019098	GSP-2511-C3427	VendorInvestigate	2025-Q4	99.18	6.30	—	Buyer-sourced	1	MARGINAL
AX-2025-019099	GSP-2511-C3427	PeptideMeter	2025-Q4	99.10	6.37	—	Buyer-sourced	1	MARGINAL
AX-2025-019100	GSP-2511-C3427	VendorInvestigate	2025-Q4	98.97	6.79	98.9	Buyer-sourced	1	MARGINAL

Batch rollup and reproducibility assessment →

Cross-sections

Other recent SLU-PP-332 records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2026-043240	SGN	SGN-2602-X9377	Janoshik	2026-Q2	98.82	5.46	97.0	Buyer-sourced	PASS
AX-2026-042724	GGPeps	GGPE-2511-R1308	Janoshik	2026-Q2	99.17	4.80	107.4	Buyer-sourced	PASS
AX-2026-043237	SGN	SGN-2602-X9377	Janoshik	2026-Q2	98.47	6.22	100.0	Supplier-supplied	PASS
AX-2026-042727	GGPeps	GGPE-2511-R1308	Janoshik	2026-Q2	98.81	4.48	—	Buyer-sourced	PASS
AX-2026-043239	SGN	SGN-2602-X9377	VendorInvestigate	2026-Q2	98.28	5.37	—	Buyer-sourced	PASS
AX-2026-043236	SGN	SGN-2602-X9377	Nordanalyt	2026-Q2	98.38	5.95	—	Buyer-sourced	PASS
AX-2026-043238	SGN	SGN-2602-X9377	PeptideMeter	2026-Q2	98.46	6.00	—	Buyer-sourced	PASS
AX-2026-042726	GGPeps	GGPE-2511-R1308	PeptideMeter	2026-Q2	98.38	4.35	92.3	Buyer-sourced	PASS

Other recent GSP records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041831	Survodutide	GSP-2603-E3156	Kestrel	2026-Q3	99.91	5.50	93.2	Buyer-sourced	0	PASS
AX-2026-041836	Survodutide	GSP-2603-E3156	Janoshik	2026-Q3	98.65	5.34	90.3	Buyer-sourced	0	PASS
AX-2026-041837	Survodutide	GSP-2603-E3156	Janoshik	2026-Q3	98.33	5.37	—	Buyer-sourced	0	PASS
AX-2026-041833	Survodutide	GSP-2603-E3156	Janoshik	2026-Q3	98.08	4.91	99.3	Buyer-sourced	0	PASS
AX-2026-041832	Survodutide	GSP-2603-E3156	VendorInvestigate	2026-Q3	98.01	5.14	99.5	Buyer-sourced	0	PASS
AX-2026-041835	Survodutide	GSP-2603-E3156	Nordanalyt	2026-Q3	98.34	5.74	89.0	Buyer-sourced	1	MARGINAL
AX-2026-041834	Survodutide	GSP-2603-E3156	VendorInvestigate	2026-Q3	97.92	5.95	—	Buyer-sourced	0	PASS
AX-2026-041838	Survodutide	GSP-2603-E3156	PeptideMeter	2026-Q3	98.30	5.01	102.4	Buyer-sourced	0	PASS