AX-2024-005011 · Semaglutide · KP lot KP-2405-C4939

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, 30 min gradient, 214 nm	97.65	% area	≥ 97.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	2.35	% area	≤ 3.0	PASS
Largest single impurity	RP-HPLC — des-AEEA semaglutide (−145 Da)	0.86	% 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	86.47	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	84.44	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	2.48	mg	2 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	2.094	mg	2 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	104.7	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	4.85	%	≤ 8.0	PASS
Counter-ion (TFA)	anion-exchange ion chromatography	8.29	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.39	%	—	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	4.39	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	18.48	min	18.42 ± 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	58,345	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [D-Aib8]-diastereomer	0.77	—	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, 30 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 58,345, 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 0.86 % impurity against a 97.65 % 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	18.48	4,746,093	97.65	—
2	des-AEEA semaglutide (−145 Da)	17.66	41,799	0.86	-145.074
3	[D-Aib8]-diastereomer	18.24	38,396	0.79	0.000
4	des-His1 truncate (−137 Da)	17.34	15,067	0.31	-137.059
5	C18 diacid mono-ester	19.84	8,749	0.18	+14.016
6	semaglutide dimer	22.19	5,346	0.11	+4111.052
7	Met(O) sulfoxide (+16 Da)	17.80	4,860	0.10	+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 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	4.85
Counter-ion (TFA)	ion chromatography	8.29
Residual solvent + inorganic residue	estimated	0.39
Total peptide content	by difference	86.47
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)	98.18	97.65	divergence +0.16 pp vs batch median
Total impurities (% area)	not stated	2.35
Largest single impurity (% area)	not stated	0.86
Water (%)	2.5	4.85
Counter-ion (%)	not stated	8.29
Peptide content (%w/w)	not stated	86.47
Endotoxin (EU/mg)	0.16	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, 34 d) → laboratory (hand-carried, 12 d) → assay.
Assay date: 28 Aug 2024
Submitted to the index: 12 Sep 2024
Laboratory: Janoshik Analytical, Ostrava, Czechia
Method basis: 30 min gradient · high-resolution MS
Verification status: PURITY ONLY

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 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 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 2

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.

nmr_qnmr12 Sep 2024

Quantitative NMR would give absolute content independent of the balance and let the two be cross-checked. On a record like this the balance is already closed; the cross-check would test the assumption behind it.

osmolality_chk12 Sep 2024

Total dissolved solids on reconstitution should reconcile with the balance. Where it does not, the discrepancy is usually an undissolved fraction rather than a measurement error.

Section 7

Related records

Same batch — lot KP-2405-C4939 n=15

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2024-005001	KP-2405-C4939	Janoshik	2024-Q3	98.02	5.06	88.5	Buyer-sourced	1	MARGINAL
AX-2024-005002	KP-2405-C4939	Janoshik	2024-Q3	98.51	5.26	92.0	Supplier-supplied	0	PASS
AX-2024-005003	KP-2405-C4939	Janoshik	2024-Q3	97.95	4.71	90.9	Buyer-sourced	0	PASS
AX-2024-005004	KP-2405-C4939	Janoshik	2024-Q3	98.01	4.67	—	Buyer-sourced	0	PASS
AX-2024-005005	KP-2405-C4939	Janoshik	2024-Q3	98.22	5.17	—	Buyer-sourced	0	PASS
AX-2024-005006	KP-2405-C4939	Janoshik	2024-Q3	98.01	4.35	—	Buyer-sourced	0	PASS
AX-2024-005007	KP-2405-C4939	Janoshik	2024-Q3	97.90	4.69	—	Buyer-sourced	0	PASS
AX-2024-005008	KP-2405-C4939	VendorInvestigate	2024-Q3	98.06	4.26	106.1	Buyer-sourced	0	PASS
AX-2024-005009	KP-2405-C4939	Janoshik	2024-Q3	97.51	5.21	96.5	Buyer-sourced	0	PASS
AX-2024-005010	KP-2405-C4939	Medutest	2024-Q3	98.70	4.51	95.1	Supplier-supplied	0	PASS
AX-2024-005012	KP-2405-C4939	Nordanalyt	2024-Q3	98.28	5.51	—	Laboratory-retained	0	PASS
AX-2024-005013	KP-2405-C4939	Janoshik	2024-Q3	97.66	5.37	97.6	Buyer-sourced	0	PASS
AX-2024-005014	KP-2405-C4939	Medutest	2024-Q3	98.31	4.90	99.4	Buyer-sourced	0	PASS
AX-2024-005015	KP-2405-C4939	Medutest	2024-Q3	98.02	5.08	88.9	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 KP records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043095	Retatrutide	KP-2607-H5774	Janoshik	2026-Q3	95.81	5.48	105.2	Buyer-sourced	0	FAIL
AX-2026-043094	Retatrutide	KP-2607-H5774	PeptideMeter	2026-Q3	96.32	6.40	—	Buyer-sourced	0	FAIL
AX-2026-043096	Retatrutide	KP-2607-H5774	VendorInvestigate	2026-Q3	96.48	6.05	104.9	Buyer-sourced	0	FAIL
AX-2026-043090	Retatrutide	KP-2607-H5774	Janoshik	2026-Q3	96.46	5.81	—	Buyer-sourced	0	FAIL
AX-2026-043091	Retatrutide	KP-2607-H5774	Janoshik	2026-Q3	96.13	5.94	—	Buyer-sourced	0	FAIL
AX-2026-043077	TB-500	KP-2605-C5214	Janoshik	2026-Q2	99.61	5.64	90.2	Buyer-sourced	0	PASS
AX-2026-043093	Retatrutide	KP-2607-H5774	Janoshik	2026-Q3	96.54	5.54	—	Buyer-sourced	0	PASS
AX-2026-043092	Retatrutide	KP-2607-H5774	Medutest	2026-Q3	96.64	6.12	—	Buyer-sourced	1	FAIL