AX-2025-020747

Semaglutide · 2 mg declared · Sangon Biotech (Shanghai) Co., Ltd. · lot SGN-2502-F9009

MARGINALPURITY ONLY

Report ID: AX-2025-020747
Compound: Semaglutide
Compound class: Incretin analogues and co-agonists
Supplier: SGN — Sangon Biotech (Shanghai) Co., Ltd.
Batch / lot: SGN-2502-F9009
Declared label claim: 2mg
Laboratory: Nordanalyt Laboratories
Assay date: 22 Sep 2025
Submitted: 09 Oct 2025
Quarter: 2025-Q3
Submitter: l.erdogan
Sample provenance: Buyer-sourced

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	99.32	% area	≥ 97.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.68	% area	≤ 3.0	PASS
Largest single impurity	RP-HPLC — des-His1 truncate (−137 Da)	0.39	% area	≤ 1.00	PASS
Identity	not ordered on this submission	not determined	—	required for VERIFIED status	NOT TESTED
Peptide content	not ordered on this submission	not determined	—	required to check label claim	NOT TESTED
Water content	Karl Fischer, coulometric, duplicate	5.48	%	≤ 8.0	PASS
Counter-ion (TFA)	anion-exchange ion chromatography	6.65	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.79	%	—	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	Off-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	3.74	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 35 min gradient	21.27	min	21.24 ± 0.45 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.34	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	69,425	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [D-Aib8]-diastereomer	0.85	—	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 69,425, and skew follows the reported asymmetry factor of 1.34. 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 99.32 % 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	21.27	4,827,260	99.32	—
2	des-His1 truncate (−137 Da)	19.94	18,955	0.39	-137.059
3	deamidated (Asn→Asp, +1 Da)	20.68	6,318	0.13	+0.984
4	des-AEEA semaglutide (−145 Da)	20.31	4,374	0.09	-145.074
5	semaglutide dimer	25.60	1,944	0.04	+4111.052
6	[D-Aib8]-diastereomer	20.99	1,458	0.03	0.000
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.

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)	99.41	99.32	divergence +0.04 pp vs batch median
Total impurities (% area)	not stated	0.68
Largest single impurity (% area)	not stated	0.39
Water (%)	3.2	5.48
Counter-ion (%)	not stated	6.65
Peptide content (%w/w)	not stated	not determined
Endotoxin (EU/mg)	0.61	not determined
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 (2–8 °C, 28 d) → laboratory (courier, ambient, 8 d) → assay.
Assay date: 22 Sep 2025
Submitted to the index: 09 Oct 2025
Laboratory: Nordanalyt Laboratories, Uppsala, Sweden
Method basis: 35 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.
How much of the named compound is in the vial. Peptide content was not determined, so recovered mass cannot be calculated and the label claim cannot be checked.
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 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.

plate_count09 Oct 2025

Plate count on this run supports the separation claimed. A high purity figure from an inefficient column is a merged peak reported as a clean one; that is not what happened here.

median_not_mean09 Oct 2025

One result at the top of the distribution should not move anybody's estimate much on its own. Purity distributions are compressed at the top and long-tailed at the bottom, so the informative observations are the low ones.

scale_up_delta09 Oct 2025

Purity usually falls between gram and kilogram scale. A figure of 99.32 % on a commercial lot rather than a laboratory batch is the more informative version of this result.

Section 7

Related records

Same batch — lot SGN-2502-F9009 n=6

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-020744	SGN-2502-F9009	VendorInvestigate	2025-Q3	99.41	5.50	96.5	Buyer-sourced	2	MARGINAL
AX-2025-020745	SGN-2502-F9009	PeptideMeter	2025-Q3	99.17	4.94	93.6	Buyer-sourced	1	MARGINAL
AX-2025-020746	SGN-2502-F9009	Nordanalyt	2025-Q3	99.42	5.30	102.4	Buyer-sourced	1	MARGINAL
AX-2025-020748	SGN-2502-F9009	Janoshik	2025-Q3	99.04	5.51	101.0	Buyer-sourced	1	MARGINAL
AX-2025-020749	SGN-2502-F9009	PeptideMeter	2025-Q3	99.92	5.10	105.2	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-2026-043376	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 SGN records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043233	Afamelanotide	SGN-2602-Y9306	Janoshik	2026-Q3	98.76	4.02	92.2	Buyer-sourced	1	MARGINAL
AX-2026-043234	Afamelanotide	SGN-2602-Y9306	Kestrel	2026-Q3	99.93	4.16	—	Buyer-sourced	0	PASS
AX-2026-043240	SLU-PP-332	SGN-2602-X9377	Janoshik	2026-Q2	98.82	5.46	97.0	Buyer-sourced	0	PASS
AX-2026-043222	ARA-290	SGN-2605-X9069	PeptideMeter	2026-Q2	98.32	7.36	—	Buyer-sourced	0	PASS
AX-2026-043237	SLU-PP-332	SGN-2602-X9377	Janoshik	2026-Q2	98.47	6.22	100.0	Supplier-supplied	0	PASS
AX-2026-043227	ARA-290	SGN-2605-X9069	PeptideMeter	2026-Q2	98.38	7.21	95.6	Buyer-sourced	0	PASS
AX-2026-043239	SLU-PP-332	SGN-2602-X9377	VendorInvestigate	2026-Q2	98.28	5.37	—	Buyer-sourced	0	PASS
AX-2026-043229	ARA-290	SGN-2605-X9069	Janoshik	2026-Q2	98.21	7.43	—	Buyer-sourced	0	PASS