AX-2025-018792 · Semaglutide · FGP lot FGP-2506-J7851

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, 15 min gradient, 214 nm	99.93	% area	≥ 97.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.07	% area	≤ 3.0	PASS
Largest single impurity	RP-HPLC — C18 diacid mono-ester	0.04	% area	≤ 1.00	PASS
Identity	not ordered on this submission	not determined	—	required for VERIFIED status	NOT TESTED
Total peptide content	by difference from the gravimetric mass balance	85.88	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	85.82	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	3.70	mg	3 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	3.175	mg	3 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	105.8	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	4.44	%	≤ 8.0	PASS
Counter-ion (TFA)	anion-exchange ion chromatography	8.96	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.72	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	0.35	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	4.43	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 15 min gradient	9.78	min	9.95 ± 0.45 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.26	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	50,988	—	≥ 20,000	PASS
Resolution to nearest impurity	vs des-His1 truncate (−137 Da)	3.21	—	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 50,988, and skew follows the reported asymmetry factor of 1.26. 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 0.04 % impurity against a 99.93 % 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	Semaglutide — main peak	9.78	4,856,908	99.93	—
2	C18 diacid mono-ester	10.46	1,944	0.04	+14.016
3	des-His1 truncate (−137 Da)	9.21	1,458	0.03	-137.059
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 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	4.44
Counter-ion (TFA)	ion chromatography	8.96
Residual solvent + inorganic residue	estimated	0.72
Total peptide content	by difference	85.88
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)	99.90	99.93	divergence -0.03 pp vs batch median
Total impurities (% area)	0.91	0.07
Largest single impurity (% area)	not stated	0.04
Water (%)	2.4	4.44
Counter-ion (%)	not stated	8.96
Peptide content (%w/w)	92.8	85.88
Endotoxin (EU/mg)	0.38	0.35
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 → submitter (ambient, 28 d) → laboratory (courier, cold pack, 9 d) → assay.
Assay date: 15 Dec 2025
Submitted to the index: 20 Dec 2025
Laboratory: Kestrel Bioanalytical, Melbourne, Australia
Method basis: 15 min gradient · unit-resolution MS
Verification status: METHOD LIMITED

What this report does not establish

That the compound is the compound named. No identity confirmation was ordered on this submission. A purity figure describes chromatographic homogeneity of whatever eluted; it does not name it.
That mass-identical impurities are absent. The gradient used is shorter than the index reference method and does not resolve the diastereomers named in the compound fingerprint. The purity figure is an upper bound.
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 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.

des_gly20 Dec 2025

At 99.93 % the deletion-sequence family is at or below the reporting threshold. On a sequence with a hindered coupling that is a statement about coupling efficiency, and a good one.

coa_template20 Dec 2025

The document that arrived with this order is on file and its fields are scored on the supplier's documentation rubric. That score describes what a buyer receives, which is the useful version.

baseline_noise20 Dec 2025

Steeper gradients drift more, and a drifting baseline on a fast run makes threshold placement the dominant integration decision. The lower panel of the figure above shows the drift subtracted.

gradient_2520 Dec 2025

The compound class minimum on this site is 25 min for incretins, 22 for melanocortins, 15 otherwise, and it is published on the method page rather than applied silently.

Section 7

Related records

Same batch — lot FGP-2506-J7851 n=12

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-018790	FGP-2506-J7851	Nordanalyt	2025-Q4	99.93	4.54	106.0	Buyer-sourced	1	MARGINAL
AX-2026-041607	FGP-2506-J7851	VendorInvestigate	2025-Q4	98.88	4.21	103.1	Laboratory-retained	1	MARGINAL
AX-2025-018791	FGP-2506-J7851	VendorInvestigate	2025-Q4	99.93	4.54	91.2	Buyer-sourced	1	MARGINAL
AX-2025-018793	FGP-2506-J7851	Janoshik	2025-Q4	99.90	5.21	—	Buyer-sourced	1	MARGINAL
AX-2025-018794	FGP-2506-J7851	Janoshik	2025-Q4	99.93	3.65	89.8	Buyer-sourced	2	MARGINAL
AX-2025-018795	FGP-2506-J7851	Nordanalyt	2025-Q4	99.93	4.14	—	Buyer-sourced	1	MARGINAL
AX-2025-018796	FGP-2506-J7851	Janoshik	2025-Q4	99.77	4.60	100.7	Buyer-sourced	1	MARGINAL
AX-2025-018797	FGP-2506-J7851	Janoshik	2025-Q4	99.79	4.31	93.5	Buyer-sourced	1	MARGINAL
AX-2025-018798	FGP-2506-J7851	Nordanalyt	2025-Q4	99.93	4.88	102.0	Buyer-sourced	1	MARGINAL
AX-2025-018799	FGP-2506-J7851	Kestrel	2025-Q4	99.93	4.76	—	Buyer-sourced	1	MARGINAL
AX-2025-018800	FGP-2506-J7851	PeptideMeter	2025-Q4	99.93	4.75	96.8	Buyer-sourced	1	MARGINAL

Batch rollup and reproducibility assessment →

Cross-sections

Other recent Semaglutide records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043376	WXT	WXT-2604-C3248	Janoshik	2026-Q3	97.08	4.22	—	Buyer-sourced	1	MARGINAL
AX-2026-042424	Homopeptide	HOMO-2604-X3806	PeptideMeter	2026-Q3	98.85	4.87	92.0	Buyer-sourced	0	PASS
AX-2026-041643	FGP	FGP-2602-M8547	Janoshik	2026-Q3	99.31	2.79	100.7	Buyer-sourced	0	PASS
AX-2026-041334	WWB	WWB-2606-N3192	Janoshik	2026-Q3	98.93	4.62	99.9	Buyer-sourced	0	PASS
AX-2026-042002	AMB	AMB-2607-N6274	VendorInvestigate	2026-Q3	98.23	6.37	97.1	Buyer-sourced	1	MARGINAL
AX-2026-041337	WWB	WWB-2606-N3192	Nordanalyt	2026-Q3	99.52	3.92	—	Buyer-sourced	0	PASS
AX-2026-042595	HJ	HJ-2608-C7002	Janoshik	2026-Q3	99.50	3.55	—	Buyer-sourced	1	MARGINAL
AX-2026-042217	TFC	TFC-2604-X9037	PeptideMeter	2026-Q3	98.95	4.61	96.9	Buyer-sourced	0	PASS

Other recent FGP records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2026-041643	Semaglutide	FGP-2602-M8547	Janoshik	2026-Q3	99.31	2.79	100.7	Buyer-sourced	PASS
AX-2026-041638	Semaglutide	FGP-2602-M8547	Janoshik	2026-Q3	99.40	2.75	105.8	Buyer-sourced	PASS
AX-2026-041641	Semaglutide	FGP-2602-M8547	PeptideMeter	2026-Q3	98.98	2.38	105.0	Buyer-sourced	PASS
AX-2026-041610	Tirzepatide	FGP-2603-L7753	Janoshik	2026-Q3	98.81	2.45	101.0	Buyer-sourced	PASS
AX-2026-041637	Semaglutide	FGP-2602-M8547	PeptideMeter	2026-Q3	99.40	2.83	—	Laboratory-retained	PASS
AX-2026-041642	Semaglutide	FGP-2602-M8547	PeptideMeter	2026-Q3	98.78	2.24	—	Buyer-sourced	PASS
AX-2026-041609	Tirzepatide	FGP-2603-L7753	Janoshik	2026-Q3	98.52	2.00	98.0	Buyer-sourced	PASS
AX-2026-041636	Semaglutide	FGP-2602-M8547	Nordanalyt	2026-Q3	99.39	2.17	—	Buyer-sourced	PASS