AX-2026-043240 · SLU-PP-332 · SGN lot SGN-2602-X9377

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, 30 min gradient, 214 nm	98.82	% area	≥ 98.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	1.18	% area	≤ 2.0	PASS
Largest single impurity	RP-HPLC — des-methyl analogue (−14 Da)	0.62	% 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)	410.1308	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+1.9	ppm	± 10	PASS
Total peptide content	by difference from the gravimetric mass balance	94.31	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	93.20	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	52.05	mg	50 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	48.511	mg	50 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	97.0	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	5.46	%	≤ 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/	0.23	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	0.98	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 lyophilised cake, intact	—	white to off-white intact cake	PASS
Reconstitution clarity	reconstituted per submitter procedure	Faint haze, clearing on standing	—	clear, no visible particulates	FAIL
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	7.00	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	15.13	min	15.28 ± 0.35 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.05	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	39,242	—	≥ 20,000	PASS
Resolution to nearest impurity	vs des-methyl analogue (−14 Da)	1.15	—	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 39,242, and skew follows the reported asymmetry factor of 1.05. 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 0.62 % impurity against a 98.82 % 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	15.13	4,802,958	98.82	—
2	des-methyl analogue (−14 Da)	14.77	30,134	0.62	-14.016
3	residual DMSO (process solvent)	5.03	17,011	0.35	0.000
4	hydrolysed ester (+18 Da)	13.89	6,318	0.13	+18.011
5	sulfoxide (+16 Da)	14.41	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 410.1308 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	411.1381	0.0008	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	5.46
Counter-ion	none expected	0.00
Residual solvent + inorganic residue	estimated	0.23
Total peptide content	by difference	94.31
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)	98.66	98.82	divergence +0.24 pp vs batch median
Total impurities (% area)	not stated	1.18
Largest single impurity (% area)	not stated	0.62
Water (%)	5.6	5.46
Counter-ion (%)	4.5	N/A
Peptide content (%w/w)	89.3	94.31
Endotoxin (EU/mg)	not stated	0.98
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 → submitter (−20 °C, 27 d) → laboratory (courier, dry ice, 11 d) → assay.
Assay date: 26 Jun 2026
Submitted to the index: 08 Jul 2026
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

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 SGN-2602-X9377 n=6

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2026-043235	SGN-2602-X9377	VendorInvestigate	2026-Q2	98.10	5.37	90.9	Buyer-sourced	PASS
AX-2026-043236	SGN-2602-X9377	Nordanalyt	2026-Q2	98.38	5.95	—	Buyer-sourced	PASS
AX-2026-043237	SGN-2602-X9377	Janoshik	2026-Q2	98.47	6.22	100.0	Supplier-supplied	PASS
AX-2026-043238	SGN-2602-X9377	PeptideMeter	2026-Q2	98.46	6.00	—	Buyer-sourced	PASS
AX-2026-043239	SGN-2602-X9377	VendorInvestigate	2026-Q2	98.28	5.37	—	Buyer-sourced	PASS

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-2026-042724	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
AX-2026-043235	SGN	SGN-2602-X9377	VendorInvestigate	2026-Q2	98.10	5.37	90.9	Buyer-sourced	PASS

Other recent SGN records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043233	Afamelanotide	SGN-2602-Y9306	Janoshik	2026-Q3	98.76	4.02	92.2	Buyer-sourced	1	MARGINAL
AX-2026-043234	Afamelanotide	SGN-2602-Y9306	Kestrel	2026-Q3	99.93	4.16	—	Buyer-sourced	0	PASS
AX-2026-043222	ARA-290	SGN-2605-X9069	PeptideMeter	2026-Q2	98.32	7.36	—	Buyer-sourced	0	PASS
AX-2026-043237	SLU-PP-332	SGN-2602-X9377	Janoshik	2026-Q2	98.47	6.22	100.0	Supplier-supplied	0	PASS
AX-2026-043227	ARA-290	SGN-2605-X9069	PeptideMeter	2026-Q2	98.38	7.21	95.6	Buyer-sourced	0	PASS
AX-2026-043239	SLU-PP-332	SGN-2602-X9377	VendorInvestigate	2026-Q2	98.28	5.37	—	Buyer-sourced	0	PASS
AX-2026-043229	ARA-290	SGN-2605-X9069	Janoshik	2026-Q2	98.21	7.43	—	Buyer-sourced	0	PASS
AX-2026-043203	GHK-Cu	SGN-2603-X8452	Medutest	2026-Q2	98.53	3.88	—	Buyer-sourced	0	PASS