AX-2025-020868 · IGF-1 LR3 · WXT lot WXT-2508-G2536

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, 15 min gradient, 214 nm	97.45	% area	≥ 95.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	2.55	% area	≤ 5.0	PASS
Largest single impurity	RP-HPLC — oxidised Met59 (+16 Da)	1.39	% area	≤ 1.00	FAIL
Identity — theoretical monoisotopic mass	calculated from molecular formula	9105.2412	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, unit resolution (single quadrupole)	9105.0700	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	-18.8	ppm	± 15	FAIL
Total peptide content	by difference from the gravimetric mass balance	89.25	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	86.97	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	0.12	mg	0.1 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	0.104	mg	0.1 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	104.0	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	4.12	%	≤ 9.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	5.84	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.79	%	—	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	5.26	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 15 min gradient	9.10	min	9.14 ± 0.50 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.12	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	60,509	—	≥ 20,000	PASS
Resolution to nearest impurity	vs disulfide-scrambled isomer	2.04	—	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 60,509, and skew follows the reported asymmetry factor of 1.12. 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 1.39 % impurity against a 97.45 % 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 LR3 — main peak	9.10	4,736,372	97.45	—
2	oxidised Met59 (+16 Da)	8.74	67,558	1.39	+15.995
3	truncated (1-70)	8.13	39,369	0.81	-1385.688
4	disulfide-scrambled isomer	9.41	6,804	0.14	0.000
5	aggregated dimer	10.70	6,318	0.13	+9105.241
6	des-13-residue N-extension (native IGF-1)	7.98	3,888	0.08	-1441.712
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 9105.2412 Da, computed from C400H625N111O116S9. 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 9105.0700 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 (%)
11+	828.7565	828.7409	-0.0156	8.6
10+	911.5314	911.5143	-0.0171	56.3
9+	1012.7007	1012.6817	-0.0190	100.0
8+	1139.1624	1139.1410	-0.0214	58.5
7+	1301.7560	1301.7316	-0.0244	8.9

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	4.12
Counter-ion (acetate)	ion chromatography	5.84
Residual solvent + inorganic residue	estimated	0.79
Total peptide content	by difference	89.25
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)	96.96	97.45	divergence -0.01 pp vs batch median
Total impurities (% area)	3.04	2.55
Largest single impurity (% area)	not stated	1.39
Water (%)	not stated	4.12
Counter-ion (%)	not stated	5.84
Peptide content (%w/w)	91.7	89.25
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 (ambient, 32 d) → laboratory (hand-carried, 2 d) → assay.
Assay date: 13 Aug 2025
Submitted to the index: 04 Sep 2025
Laboratory: Kestrel Bioanalytical, Melbourne, Australia
Method basis: 15 min gradient · unit-resolution MS
Verification status: IDENTITY CONSISTENT

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 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 3

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.

ppm_error04 Sep 2025

A single excursion of this size against a clean run of prior results on the same instrument is a calibration event with a date on it. The laboratory's own sequence log would place it; the index does not hold one.

ms_confirm04 Sep 2025

Nothing about -18.8 ppm bears on the purity figure on this record. Chromatographic homogeneity and mass accuracy are independent measurements and only one of them is in question here.

selection_bias04 Sep 2025

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

Section 7

Related records

Same batch — lot WXT-2508-G2536 n=6

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-020867	WXT-2508-G2536	Nordanalyt	2025-Q3	97.05	4.03	87.0	Laboratory-retained	1	MARGINAL
AX-2025-020869	WXT-2508-G2536	Janoshik	2025-Q3	96.89	3.75	—	Buyer-sourced	0	PASS
AX-2025-020870	WXT-2508-G2536	Janoshik	2025-Q3	96.78	3.49	96.0	Buyer-sourced	0	PASS
AX-2025-020871	WXT-2508-G2536	Janoshik	2025-Q3	96.85	4.15	—	Buyer-sourced	0	PASS
AX-2025-020872	WXT-2508-G2536	VendorInvestigate	2025-Q3	97.64	4.10	96.0	Buyer-sourced	0	PASS

Batch rollup and reproducibility assessment →

Cross-sections

Other recent IGF-1 LR3 records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042503	Homopeptide	HOMO-2607-P5131	Janoshik	2026-Q3	99.36	5.99	—	Buyer-sourced	0	PASS
AX-2026-042509	Homopeptide	HOMO-2607-P5131	Medutest	2026-Q3	98.63	6.23	103.0	Buyer-sourced	0	PASS
AX-2026-041930	SinoPep	SNP-2606-D4620	Medutest	2026-Q3	98.54	5.37	93.8	Buyer-sourced	0	PASS
AX-2026-041931	SinoPep	SNP-2606-D4620	PeptideMeter	2026-Q3	97.93	5.19	93.4	Buyer-sourced	0	PASS
AX-2026-041924	SinoPep	SNP-2606-D4620	Janoshik	2026-Q3	97.95	5.34	—	Buyer-sourced	0	PASS
AX-2026-042504	Homopeptide	HOMO-2607-P5131	Janoshik	2026-Q3	99.08	6.26	105.0	Buyer-sourced	0	PASS
AX-2026-042499	Homopeptide	HOMO-2607-P5131	Medutest	2026-Q3	98.48	5.98	88.0	Buyer-sourced	1	MARGINAL
AX-2026-042508	Homopeptide	HOMO-2607-P5131	Janoshik	2026-Q3	98.89	6.22	—	Buyer-sourced	1	MARGINAL

Other recent WXT records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043376	Semaglutide	WXT-2604-C3248	Janoshik	2026-Q3	97.08	4.22	—	Buyer-sourced	1	MARGINAL
AX-2026-043429	L-Glutathione (reduced)	WXT-2605-B3833	Nordanalyt	2026-Q3	98.48	6.58	96.9	Supplier-supplied	1	FAIL
AX-2026-043347	Leuprolide	WXT-2604-K2596	PeptideMeter	2026-Q3	99.16	5.99	93.6	Buyer-sourced	0	PASS
AX-2026-043353	Leuprolide	WXT-2604-K2596	Janoshik	2026-Q3	99.19	4.90	95.3	Laboratory-retained	0	PASS
AX-2026-043345	Leuprolide	WXT-2604-K2596	Janoshik	2026-Q3	98.93	5.28	—	Buyer-sourced	0	PASS
AX-2026-043424	L-Glutathione (reduced)	WXT-2605-B3833	PeptideMeter	2026-Q3	98.37	6.86	—	Buyer-sourced	0	FAIL
AX-2026-043374	Semaglutide	WXT-2604-C3248	Janoshik	2026-Q3	97.00	3.56	—	Buyer-sourced	1	MARGINAL
AX-2026-043377	Semaglutide	WXT-2604-C3248	PeptideMeter	2026-Q3	97.20	4.08	—	Buyer-sourced	1	MARGINAL