AX-2024-004548 · Semaglutide · JEEP lot JEEP-2405-D3060

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 — des-AEEA semaglutide (−145 Da)	0.05	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	4111.0524	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, unit resolution (single quadrupole)	4111.0676	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+3.7	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	85.44	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	85.38	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	10.92	mg	10 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	9.323	mg	10 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	93.2	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	4.32	%	≤ 8.0	PASS
Counter-ion (TFA)	anion-exchange ion chromatography	9.68	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.56	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	5.32	EU/mg	≤ 5.0	FAIL
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	3.73	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 15 min gradient	10.02	min	9.95 ± 0.45 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.09	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	63,836	—	≥ 20,000	PASS
Resolution to nearest impurity	vs Met(O) sulfoxide (+16 Da)	2.09	—	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 63,836, and skew follows the reported asymmetry factor of 1.09. 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 0.05 % 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	10.02	4,856,908	99.93	—
2	des-AEEA semaglutide (−145 Da)	9.61	2,430	0.05	-145.074
3	Met(O) sulfoxide (+16 Da)	9.68	972	0.02	+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 4111.0524 Da, computed from C187H291N45O59. 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 4111.0676 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 (%)
6+	686.1827	686.1852	0.0025	8.4
5+	823.2178	823.2208	0.0030	59.5
4+	1028.7704	1028.7742	0.0038	100.0
3+	1371.3581	1371.3631	0.0050	62.2
2+	2056.5335	2056.5411	0.0076	8.6

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 (TFA)	ion chromatography	9.68
Residual solvent + inorganic residue	estimated	0.56
Total peptide content	by difference	85.44
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)	99.65	99.93	divergence +0.65 pp vs batch median
Total impurities (% area)	0.35	0.07
Largest single impurity (% area)	not stated	0.05
Water (%)	2.3	4.32
Counter-ion (%)	3.8	9.68
Peptide content (%w/w)	93.3	85.44
Endotoxin (EU/mg)	not stated	5.32
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: Supplier-supplied
Evidentiary weight: Weaker evidence. Read with the caveat below.
Chain of custody: Supplier despatch → laboratory direct (courier, cold pack, 3 d) → assay. Submitter did not handle the vial.
Assay date: 21 Oct 2024
Submitted to the index: 09 Nov 2024
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 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 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 5

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.

endotoxin_limit09 Nov 2024

Endotoxin burden at this level usually tracks water quality at the fill step rather than anything about the synthesis. A high-purity lot with high endotoxin is an entirely coherent result and this is one.

Contributor #A-447109 Nov 2024

Endotoxin determined but the LAL method is not stated. Kinetic chromogenic and gel-clot give different results and different sensitivity. The value cannot be interpreted without knowing which.

bland_altman09 Nov 2024

High endotoxin 5.32 EU/mg on high-purity material vs purity suggests water quality at the fill step. If the lot was lyophilised from non-purified water, this is the expected finding.

dedupe_logic09 Nov 2024

5.32 EU/mg from an older lot. Endotoxins are heat-stable and drift is rare. If this matches fresh-lot median from the same supplier, the number is stable.

tri_agonist09 Nov 2024

Purity 99.93 % and endotoxin 5.32 EU/mg are unrelated — purity measures synthesis quality, endotoxin measures fill-step water quality. The combination here is coherent and expected together.

Section 7

Related records

Same batch — lot JEEP-2405-D3060 n=17

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2024-004549	JEEP-2405-D3060	Medutest	2024-Q4	99.22	4.73	—	Supplier-supplied	3	MARGINAL
AX-2024-004550	JEEP-2405-D3060	PeptideMeter	2024-Q4	99.39	4.41	99.0	Supplier-supplied	1	MARGINAL
AX-2024-004551	JEEP-2405-D3060	Janoshik	2024-Q4	98.70	4.12	100.9	Supplier-supplied	2	MARGINAL
AX-2024-004552	JEEP-2405-D3060	Janoshik	2024-Q4	98.57	4.64	92.2	Laboratory-retained	0	PASS
AX-2024-004553	JEEP-2405-D3060	PeptideMeter	2024-Q4	99.08	4.77	88.8	Supplier-supplied	3	MARGINAL
AX-2024-004554	JEEP-2405-D3060	Janoshik	2024-Q4	99.00	3.77	—	Supplier-supplied	1	MARGINAL
AX-2024-004555	JEEP-2405-D3060	Medutest	2024-Q4	98.91	4.38	—	Supplier-supplied	2	MARGINAL
AX-2024-004556	JEEP-2405-D3060	Janoshik	2024-Q4	98.88	4.62	104.0	Supplier-supplied	1	MARGINAL
AX-2024-004557	JEEP-2405-D3060	PeptideMeter	2024-Q4	99.11	4.40	—	Supplier-supplied	3	FAIL
AX-2024-004558	JEEP-2405-D3060	Medutest	2024-Q4	98.56	4.79	94.0	Supplier-supplied	1	MARGINAL
AX-2024-004559	JEEP-2405-D3060	Janoshik	2024-Q4	98.61	4.21	—	Supplier-supplied	2	MARGINAL
AX-2024-004560	JEEP-2405-D3060	PeptideMeter	2024-Q4	99.13	4.75	99.0	Supplier-supplied	1	MARGINAL
AX-2024-004561	JEEP-2405-D3060	Janoshik	2024-Q4	98.49	5.33	94.7	Supplier-supplied	2	MARGINAL
AX-2024-004562	JEEP-2405-D3060	Kestrel	2024-Q4	99.93	4.94	—	Supplier-supplied	1	MARGINAL
AX-2024-004563	JEEP-2405-D3060	VendorInvestigate	2024-Q4	98.14	4.48	97.6	Buyer-sourced	2	MARGINAL
AX-2024-004564	JEEP-2405-D3060	Medutest	2024-Q4	99.05	4.43	104.0	Supplier-supplied	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-2026-041334	WWB	WWB-2606-N3192	Janoshik	2026-Q3	98.83	5.04	—	Supplier-supplied	1	MARGINAL
AX-2026-041932	TFC	TFC-2604-X4301	Janoshik	2026-Q3	98.88	4.31	—	Supplier-supplied	0	PASS
AX-2026-042347	HJ	HJ-2608-C3931	VendorInvestigate	2026-Q3	98.80	3.41	100.2	Buyer-sourced	1	MARGINAL
AX-2026-041886	JEEP	JEEP-2607-X3911	Nordanalyt	2026-Q3	99.19	4.03	96.4	Supplier-supplied	2	MARGINAL
AX-2026-041337	WWB	WWB-2606-N3192	Nordanalyt	2026-Q3	98.96	4.81	—	Supplier-supplied	1	MARGINAL
AX-2026-042172	Homopeptide	HOMO-2604-X8921	Janoshik	2026-Q3	99.64	5.16	91.9	Supplier-supplied	1	MARGINAL
AX-2026-041767	FGP	FGP-2602-M1508	PeptideMeter	2026-Q3	98.65	2.54	—	Supplier-supplied	2	FAIL
AX-2026-041882	JEEP	JEEP-2607-X3911	Nordanalyt	2026-Q3	99.17	4.52	—	Supplier-supplied	1	MARGINAL

Other recent JEEP records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041847	TB-500	JEEP-2602-V3434	Nordanalyt	2026-Q3	99.72	3.85	—	Supplier-supplied	1	MARGINAL
AX-2026-041886	Semaglutide	JEEP-2607-X3911	Nordanalyt	2026-Q3	99.19	4.03	96.4	Supplier-supplied	2	MARGINAL
AX-2026-041882	Semaglutide	JEEP-2607-X3911	Nordanalyt	2026-Q3	99.17	4.52	—	Supplier-supplied	1	MARGINAL
AX-2026-041845	TB-500	JEEP-2602-V3434	Janoshik	2026-Q3	99.72	4.04	102.2	Supplier-supplied	1	MARGINAL
AX-2026-041921	TB-500	JEEP-2605-M4874	Janoshik	2026-Q3	99.90	1.76	—	Supplier-supplied	2	MARGINAL
AX-2026-041922	TB-500	JEEP-2605-M4874	Janoshik	2026-Q3	99.41	2.60	95.7	Laboratory-retained	2	MARGINAL
AX-2026-041928	TB-500	JEEP-2605-M4874	Janoshik	2026-Q3	99.88	1.84	92.8	Laboratory-retained	2	MARGINAL
AX-2026-041849	TB-500	JEEP-2602-V3434	VendorInvestigate	2026-Q3	99.73	3.60	88.6	Buyer-sourced	2	MARGINAL