AX-2026-042672 · IGF-1 DES (1-3) · SWB lot SWB-2601-Y8497

Section 1

Results

Measured against the index acceptance specification for the growth-hormone axis peptides 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	98.22	% area	≥ 95.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	1.78	% area	≤ 5.0	PASS
Largest single impurity	RP-HPLC — full-length IGF-1 (+343 Da)	0.89	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	7365.7188	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, high resolution (ESI-TOF/QTOF)	7365.3571	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	-49.1	ppm	± 15	FAIL
Total peptide content	by difference from the gravimetric mass balance	89.67	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	88.07	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	0.11	mg	0.1 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	0.097	mg	0.1 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	97.0	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	4.32	%	≤ 9.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	5.08	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.93	%	—	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	4.96	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 35 min gradient	18.37	min	18.29 ± 0.50 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.10	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	66,980	—	≥ 20,000	PASS
Resolution to nearest impurity	vs des(1-4) over-truncate (−87 Da)	1.44	—	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 66,980, and skew follows the reported asymmetry factor of 1.10. 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 0.89 % impurity against a 98.22 % 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	IGF-1 DES (1-3) — main peak	18.37	4,773,796	98.22	—
2	full-length IGF-1 (+343 Da)	18.93	43,257	0.89	+342.166
3	disulfide-scrambled isomer	19.05	24,788	0.51	0.000
4	des(1-4) over-truncate (−87 Da)	17.95	9,721	0.20	-87.032
5	aggregated dimer	21.93	8,749	0.18	+7365.719
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 7365.7188 Da, computed from C317H508N92O95S7. 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 7365.3571 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 (%)
9+	819.4205	819.3803	-0.0402	8.2
8+	921.7221	921.6769	-0.0452	56.8
7+	1053.2528	1053.2011	-0.0517	100.0
6+	1228.6271	1228.5668	-0.0603	53.5
5+	1474.1510	1474.0787	-0.0723	9.2

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	4.32
Counter-ion (acetate)	ion chromatography	5.08
Residual solvent + inorganic residue	estimated	0.93
Total peptide content	by difference	89.67
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)	98.33	98.22	divergence +0.11 pp vs batch median
Total impurities (% area)	not stated	1.78
Largest single impurity (% area)	not stated	0.89
Water (%)	2.5	4.32
Counter-ion (%)	not stated	5.08
Peptide content (%w/w)	not stated	89.67
Endotoxin (EU/mg)	not stated	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: Buyer-sourced
Evidentiary weight: Strongest available evidence in this index.
Chain of custody: Retail purchase → submitter (2–8 °C, 9 d) → laboratory (courier, ambient, 12 d) → assay.
Assay date: 24 Apr 2026
Submitted to the index: 08 May 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 the protein is correctly folded. Reverse-phase chromatography measures hydrophobic heterogeneity. A correctly-massed, chromatographically-homogeneous recombinant protein can be entirely mis-paired at its disulfides. Purity here is an upper bound and nothing more.
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.

selection_bias08 May 2026

Provenance handles supplier selection. It does not handle submitter selection, which is the larger confounder and the one the index cannot measure.

valley_drop08 May 2026

The index's position is that the integration convention must be stated, not that any particular convention must be used. Both are defensible; only one can be reported and it should be named.

coa_reader08 May 2026

A closed balance is what converts a purity figure into a mass. 88.07 %w/w target content on a 0.1 mg claim gives 0.10 mg recovered, and every step of that is on the record.

dimer_disulfide08 May 2026

An intermolecular dimer appears at roughly twice the parent mass and reduces cleanly. It is a concentration and oxidation-condition artefact from the folding step rather than a sequence problem.

Section 7

Related records

Same batch — lot SWB-2601-Y8497 n=1

This is the only report on this lot. One report is not a batch characterisation.

Batch rollup and reproducibility assessment →

Cross-sections

Other recent IGF-1 DES (1-3) records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2025-020588	SSA	SSA-2509-Y7224	Janoshik	2025-Q4	97.77	6.23	101.0	Buyer-sourced	PASS
AX-2025-020590	SSA	SSA-2509-Y7224	Janoshik	2025-Q4	97.45	6.55	—	Buyer-sourced	PASS
AX-2025-020589	SSA	SSA-2509-Y7224	Janoshik	2025-Q4	98.07	6.48	—	Buyer-sourced	PASS
AX-2024-005084	SSA	SSA-2403-F6772	Janoshik	2024-Q2	98.51	4.17	98.0	Buyer-sourced	PASS
AX-2024-005080	SSA	SSA-2403-F6772	Janoshik	2024-Q2	99.06	4.31	99.0	Buyer-sourced	PASS
AX-2024-005081	SSA	SSA-2403-F6772	Janoshik	2024-Q2	99.12	3.35	100.0	Laboratory-retained	PASS
AX-2024-005087	SSA	SSA-2403-F6772	PeptideMeter	2024-Q2	99.67	4.18	99.0	Buyer-sourced	PASS
AX-2024-005088	SSA	SSA-2403-F6772	PeptideMeter	2024-Q2	99.17	3.40	109.0	Supplier-supplied	PASS

Other recent SWB records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2026-042637	Semaglutide	SWB-2602-X7905	Janoshik	2026-Q3	98.37	4.26	102.9	Buyer-sourced	PASS
AX-2026-042645	Semaglutide	SWB-2602-X7905	Medutest	2026-Q3	98.48	4.52	95.2	Buyer-sourced	PASS
AX-2026-042642	Semaglutide	SWB-2602-X7905	PeptideMeter	2026-Q3	97.96	4.48	90.8	Buyer-sourced	PASS
AX-2026-042640	Semaglutide	SWB-2602-X7905	PeptideMeter	2026-Q3	98.55	4.29	—	Buyer-sourced	PASS
AX-2026-042638	Semaglutide	SWB-2602-X7905	Janoshik	2026-Q3	98.74	3.65	—	Buyer-sourced	PASS
AX-2026-042639	Semaglutide	SWB-2602-X7905	Janoshik	2026-Q3	98.77	4.21	—	Supplier-supplied	PASS
AX-2026-042641	Semaglutide	SWB-2602-X7905	Janoshik	2026-Q3	98.86	4.48	99.1	Buyer-sourced	PASS
AX-2026-042644	Semaglutide	SWB-2602-X7905	PeptideMeter	2026-Q3	98.76	3.57	97.7	Buyer-sourced	PASS