AX-2024-004281 · Semaglutide · QSC lot QSC-2408-D6095

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	99.40	% area	≥ 97.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.60	% area	≤ 3.0	PASS
Largest single impurity	RP-HPLC — [D-Aib8]-diastereomer	0.39	% 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)	4111.0656	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+3.2	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	88.70	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	88.17	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	5.54	mg	5 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	4.885	mg	5 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	97.7	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	2.63	%	≤ 8.0	PASS
Counter-ion (TFA)	anion-exchange ion chromatography	7.75	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.92	%	—	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	3.54	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	18.40	min	18.42 ± 0.45 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.23	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	65,918	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [D-Aib8]-diastereomer	0.82	—	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 65,918, and skew follows the reported asymmetry factor of 1.23. 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 0.39 % impurity against a 99.40 % 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	18.40	4,831,148	99.40	—
2	[D-Aib8]-diastereomer	18.16	18,955	0.39	0.000
3	des-AEEA semaglutide (−145 Da)	17.58	4,860	0.10	-145.074
4	deamidated (Asn→Asp, +1 Da)	17.89	2,430	0.05	+0.984
5	Met(O) sulfoxide (+16 Da)	17.72	1,458	0.03	+15.995
6	des-His1 truncate (−137 Da)	17.26	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 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 4111.0656 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	686.1849	0.0022	8.5
5+	823.2178	823.2204	0.0026	56.2
4+	1028.7704	1028.7737	0.0033	100.0
3+	1371.3581	1371.3625	0.0044	55.5
2+	2056.5335	2056.5401	0.0066	8.8

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	2.63
Counter-ion (TFA)	ion chromatography	7.75
Residual solvent + inorganic residue	estimated	0.92
Total peptide content	by difference	88.70
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	99.40	divergence -0.25 pp vs batch median
Total impurities (% area)	1.00	0.60
Largest single impurity (% area)	0.63	0.39
Water (%)	0.7	2.63
Counter-ion (%)	not stated	7.75
Peptide content (%w/w)	94.5	88.70
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, 33 d) → laboratory (courier, cold pack, 10 d) → assay.
Assay date: 29 Jul 2024
Submitted to the index: 14 Aug 2024
Laboratory: Janoshik Analytical, Ostrava, Czechia
Method basis: 30 min gradient · high-resolution MS
Verification status: VERIFIED

What this report does not establish

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 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.

fill_homogeneity14 Aug 2024

A high figure on one vial is a statement about one vial. The within-lot spread on the batch rollup is what tells you whether the bulk was well mixed, and it is the rarer and more useful number.

aib_coupling14 Aug 2024

Hindered couplings are where a synthesis loses purity, and the deletion products they leave are the first thing to look for. On this record they are not there in quantity.

coa_template14 Aug 2024

The certificate for QSC-2408-D6095 carries a named related-substances table rather than a totals line. That is what makes 99.40 % checkable against this record instead of merely comparable to it.

ppm_error14 Aug 2024

Well inside class limit. Worth noting that the class limits are set by mass rather than globally, because the same ppm is a different number of daltons at 340 and at 4,800.

Section 7

Related records

Same batch — lot QSC-2408-D6095 n=7

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2024-004277	QSC-2408-D6095	Janoshik	2024-Q3	99.68	2.57	106.9	Supplier-supplied	1	MARGINAL
AX-2024-004278	QSC-2408-D6095	VendorInvestigate	2024-Q3	98.99	2.90	—	Laboratory-retained	1	MARGINAL
AX-2024-004279	QSC-2408-D6095	VendorInvestigate	2024-Q3	99.29	3.18	98.7	Buyer-sourced	1	MARGINAL
AX-2024-004280	QSC-2408-D6095	Nordanalyt	2024-Q3	98.77	3.05	93.5	Buyer-sourced	1	MARGINAL
AX-2024-004282	QSC-2408-D6095	Janoshik	2024-Q3	99.07	2.73	103.0	Laboratory-retained	1	MARGINAL
AX-2024-004283	QSC-2408-D6095	Medutest	2024-Q3	99.25	2.57	—	Buyer-sourced	2	FAIL

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 QSC records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041599	CJC-1295 (no DAC)	QSC-2606-V7416	VendorInvestigate	2026-Q3	97.96	3.52	—	Buyer-sourced	1	FAIL
AX-2026-041601	CJC-1295 (no DAC)	QSC-2606-V7416	Kestrel	2026-Q3	98.33	4.10	—	Buyer-sourced	1	MARGINAL
AX-2026-041602	CJC-1295 (no DAC)	QSC-2606-V7416	VendorInvestigate	2026-Q3	98.36	3.38	101.8	Buyer-sourced	1	MARGINAL
AX-2026-041477	Triptorelin	QSC-2607-C5749	Nordanalyt	2026-Q3	99.53	3.42	—	Buyer-sourced	0	PASS
AX-2026-041600	CJC-1295 (no DAC)	QSC-2606-V7416	Nordanalyt	2026-Q3	97.74	4.91	100.9	Buyer-sourced	1	FAIL
AX-2026-041603	CJC-1295 (no DAC)	QSC-2606-V7416	PeptideMeter	2026-Q3	98.43	4.20	—	Buyer-sourced	1	MARGINAL
AX-2026-041606	CJC-1295 (no DAC)	QSC-2606-V7416	Janoshik	2026-Q3	98.03	3.58	—	Buyer-sourced	1	MARGINAL
AX-2026-041585	Liraglutide	QSC-2605-W7381	Medutest	2026-Q3	99.59	5.09	92.8	Laboratory-retained	0	PASS