AX-2024-004181 · Semaglutide · WWB lot WWB-2410-D2737

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, 35 min gradient, 214 nm	99.44	% area	≥ 97.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.56	% area	≤ 3.0	PASS
Largest single impurity	RP-HPLC — des-His1 truncate (−137 Da)	0.33	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	4111.0524	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, high resolution (ESI-TOF/QTOF)	4111.0466	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	-1.4	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	87.20	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	86.71	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	2.42	mg	2 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	2.098	mg	2 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	104.9	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	1.53	%	≤ 8.0	PASS
Counter-ion (TFA)	anion-exchange ion chromatography	10.83	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.44	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	0.78	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 cake, partially collapsed	—	white to off-white intact cake	FAIL
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	4.53	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 35 min gradient	21.30	min	21.24 ± 0.45 (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	58,603	—	≥ 20,000	PASS
Resolution to nearest impurity	vs des-AEEA semaglutide (−145 Da)	2.65	—	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 58,603, 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 0.33 % impurity against a 99.44 % 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	21.30	4,833,092	99.44	—
2	des-His1 truncate (−137 Da)	19.97	16,039	0.33	-137.059
3	C18 diacid mono-ester	22.89	6,804	0.14	+14.016
4	des-AEEA semaglutide (−145 Da)	20.34	2,430	0.05	-145.074
5	semaglutide dimer	25.63	1,944	0.04	+4111.052
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, high-resolution instrument. Sticks are placed at m/z = (M + z × 1.007276)/z for the observed neutral mass of 4111.0466 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	686.1817	-0.0010	8.3
5+	823.2178	823.2166	-0.0012	59.2
4+	1028.7704	1028.7689	-0.0015	100.0
3+	1371.3581	1371.3561	-0.0020	59.5
2+	2056.5335	2056.5306	-0.0029	8.1

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	1.53
Counter-ion (TFA)	ion chromatography	10.83
Residual solvent + inorganic residue	estimated	0.44
Total peptide content	by difference	87.20
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)	99.0	99.44	divergence -0.36 pp vs batch median
Total impurities (% area)	1.00	0.56
Largest single impurity (% area)	not stated	0.33
Water (%)	0.4	1.53
Counter-ion (%)	not stated	10.83
Peptide content (%w/w)	94.8	87.20
Endotoxin (EU/mg)	not stated	0.78
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, 6 d) → laboratory (hand-carried, 7 d) → assay.
Assay date: 20 Oct 2024
Submitted to the index: 10 Nov 2024
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 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 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.

racemisation_ala10 Nov 2024

Epimerisation during activation produces a diastereomer that is mass-identical and only chromatographically separable. At this gradient length the separation exists, and 99.44 % is net of it.

quad_unit10 Nov 2024

Identity confirmed and purity at 99.44 %. The two answer different questions — what it is, and how much else is in it — and a record carrying both is the version worth citing.

units_pedant10 Nov 2024

Reported as signed ppm, which is the right convention: direction carries information about calibration that a modulus discards.

Section 7

Related records

Same batch — lot WWB-2410-D2737 n=12

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2024-004171	WWB-2410-D2737	Medutest	2024-Q4	99.34	1.69	—	Buyer-sourced	1	MARGINAL
AX-2024-004172	WWB-2410-D2737	Janoshik	2024-Q4	99.40	1.59	—	Buyer-sourced	1	MARGINAL
AX-2024-004173	WWB-2410-D2737	VendorInvestigate	2024-Q4	99.37	1.77	94.8	Buyer-sourced	1	MARGINAL
AX-2024-004174	WWB-2410-D2737	Nordanalyt	2024-Q4	99.00	1.31	—	Buyer-sourced	1	MARGINAL
AX-2024-004175	WWB-2410-D2737	PeptideMeter	2024-Q4	99.33	1.45	—	Buyer-sourced	1	MARGINAL
AX-2024-004176	WWB-2410-D2737	Janoshik	2024-Q4	99.30	1.65	—	Buyer-sourced	1	MARGINAL
AX-2024-004177	WWB-2410-D2737	Medutest	2024-Q4	99.14	1.19	—	Laboratory-retained	1	MARGINAL
AX-2024-004178	WWB-2410-D2737	Janoshik	2024-Q4	99.33	1.29	—	Buyer-sourced	1	MARGINAL
AX-2024-004179	WWB-2410-D2737	Janoshik	2024-Q4	99.47	1.11	—	Buyer-sourced	1	MARGINAL
AX-2024-004180	WWB-2410-D2737	Janoshik	2024-Q4	99.69	1.00	—	Buyer-sourced	1	MARGINAL
AX-2024-004182	WWB-2410-D2737	Janoshik	2024-Q4	99.58	1.69	91.3	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 WWB records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041275	Liraglutide	WWB-2607-X2189	Nordanalyt	2026-Q3	99.33	4.39	—	Buyer-sourced	1	MARGINAL
AX-2026-041334	Semaglutide	WWB-2606-N3192	Janoshik	2026-Q3	98.93	4.62	99.9	Buyer-sourced	0	PASS
AX-2026-041337	Semaglutide	WWB-2606-N3192	Nordanalyt	2026-Q3	99.52	3.92	—	Buyer-sourced	0	PASS
AX-2026-041335	Semaglutide	WWB-2606-N3192	Janoshik	2026-Q3	99.15	4.27	98.9	Buyer-sourced	0	PASS
AX-2026-041271	Liraglutide	WWB-2607-X2189	Medutest	2026-Q3	99.52	4.57	97.4	Buyer-sourced	1	MARGINAL
AX-2026-041328	Semaglutide	WWB-2606-N3192	Janoshik	2026-Q3	98.99	4.47	106.1	Buyer-sourced	0	PASS
AX-2026-041333	Semaglutide	WWB-2606-N3192	Janoshik	2026-Q3	99.18	4.51	90.4	Laboratory-retained	0	PASS
AX-2026-041273	Liraglutide	WWB-2607-X2189	Janoshik	2026-Q3	99.31	5.52	104.8	Buyer-sourced	1	MARGINAL