AX-2025-020115

Semaglutide · 2 mg declared · Shanghai ERP Biotechnology Co., Ltd. · lot ERP-2508-S8293

MARGINALIDENTITY CONSISTENT

Report ID: AX-2025-020115
Compound: Semaglutide
Compound class: Incretin analogues and co-agonists
Supplier: ERP — Shanghai ERP Biotechnology Co., Ltd.
Batch / lot: ERP-2508-S8293
Declared label claim: 2mg
Laboratory: Janoshik Analytical
Assay date: 21 Sep 2025
Submitted: 17 Oct 2025
Quarter: 2025-Q3
Submitter: s.adeyemi
Sample provenance: Laboratory-retained

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	99.35	% area	≥ 97.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.65	% area	≤ 3.0	PASS
Largest single impurity	RP-HPLC — Met(O) sulfoxide (+16 Da)	0.40	% 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)	4111.0672	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+3.6	ppm	± 15	PASS
Peptide content	not ordered on this submission	not determined	—	required to check label claim	NOT TESTED
Water content	Karl Fischer, coulometric, duplicate	3.44	%	≤ 8.0	PASS
Counter-ion (TFA)	anion-exchange ion chromatography	10.03	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.82	%	—	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	Visible particulates, did not clear	—	clear, no visible particulates	FAIL
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	3.74	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	18.42	min	18.42 ± 0.45 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	0.86	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	74,995	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [D-Aib8]-diastereomer	0.87	—	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 74,995, and skew follows the reported asymmetry factor of 0.86. 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 0.40 % impurity against a 99.35 % 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	18.42	4,828,718	99.35	—
2	Met(O) sulfoxide (+16 Da)	17.74	19,441	0.40	+15.995
3	[D-Aib8]-diastereomer	18.18	7,290	0.15	0.000
4	des-AEEA semaglutide (−145 Da)	17.60	2,916	0.06	-145.074
5	C18 diacid mono-ester	19.78	972	0.02	+14.016
6	des-His1 truncate (−137 Da)	17.28	972	0.02	-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 4111.0672 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	686.1851	0.0024	8.3
5+	823.2178	823.2207	0.0029	52.2
4+	1028.7704	1028.7741	0.0037	100.0
3+	1371.3581	1371.3630	0.0049	51.9
2+	2056.5335	2056.5409	0.0074	7.6

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.

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	99.35	divergence -0.38 pp vs batch median
Total impurities (% area)	not stated	0.65
Largest single impurity (% area)	not stated	0.40
Water (%)	not stated	3.44
Counter-ion (%)	8.9	10.03
Peptide content (%w/w)	87.0	not determined
Endotoxin (EU/mg)	not stated	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: Laboratory-retained
Evidentiary weight: Provenance documented, selection uncontrolled.
Chain of custody: Laboratory retained sample (−20 °C, 28 d since original receipt) → re-assay.
Assay date: 21 Sep 2025
Submitted to the index: 17 Oct 2025
Laboratory: Janoshik Analytical, Ostrava, Czechia
Method basis: 30 min gradient · high-resolution MS
Verification status: IDENTITY CONSISTENT

What this report does not establish

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.

quarter_over_quarter17 Oct 2025

Single records do not establish trends. Where this supplier's quarterly medians are stable across four quarters, a result like this reads as the process rather than the draw — and the timeline page is where to check that.

ms_confirm17 Oct 2025

+3.6 ppm at this mass is a clean identity confirmation. With retention at 18.42 min, Semaglutide is established as the species measured. Note what it does not exclude: a mass-identical diastereomer, which no mass measurement of any resolution can.

ppm_error17 Oct 2025

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 ERP-2508-S8293 n=6

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-020114	ERP-2508-S8293	Janoshik	2025-Q3	99.49	3.39	—	Supplier-supplied	1	MARGINAL
AX-2025-020116	ERP-2508-S8293	Janoshik	2025-Q3	98.98	3.61	103.0	Buyer-sourced	1	MARGINAL
AX-2025-020117	ERP-2508-S8293	Janoshik	2025-Q3	99.37	3.64	—	Buyer-sourced	1	MARGINAL
AX-2025-020118	ERP-2508-S8293	Nordanalyt	2025-Q3	99.38	2.96	—	Buyer-sourced	1	MARGINAL
AX-2025-020119	ERP-2508-S8293	Janoshik	2025-Q3	99.38	3.11	103.7	Laboratory-retained	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 ERP records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042706	Survodutide	ERP-2605-E9865	PeptideMeter	2026-Q3	98.38	5.33	103.5	Buyer-sourced	0	PASS
AX-2026-042704	Tesamorelin	ERP-2604-W9463	Janoshik	2026-Q3	99.02	4.08	—	Buyer-sourced	1	MARGINAL
AX-2026-042705	Survodutide	ERP-2605-E9865	Janoshik	2026-Q3	98.24	5.36	92.3	Buyer-sourced	0	PASS
AX-2026-042708	GHK-Cu	ERP-2601-F9816	Nordanalyt	2026-Q2	98.88	3.87	91.5	Buyer-sourced	1	MARGINAL
AX-2026-042694	Liraglutide	ERP-2601-P8985	Kestrel	2026-Q2	99.25	4.35	107.3	Buyer-sourced	1	MARGINAL
AX-2026-042707	GHK-Cu	ERP-2601-F9816	Janoshik	2026-Q2	98.53	4.70	96.3	Buyer-sourced	1	MARGINAL
AX-2026-042711	GHK-Cu	ERP-2601-F9816	Kestrel	2026-Q2	98.53	3.84	89.7	Laboratory-retained	2	MARGINAL
AX-2026-042722	Tirzepatide	ERP-2512-T9616	Medutest	2026-Q2	99.18	2.07	—	Buyer-sourced	1	MARGINAL