AX-2025-019949

Semaglutide · 10 mg declared · Hubei Jianxiang Bioscience Co., Ltd. · lot HJ-2504-Y7274

MARGINALPURITY ONLY

Report ID: AX-2025-019949
Compound: Semaglutide
Compound class: Incretin analogues and co-agonists
Supplier: HJ — Hubei Jianxiang Bioscience Co., Ltd.
Batch / lot: HJ-2504-Y7274
Declared label claim: 10mg
Laboratory: Nordanalyt Laboratories
Assay date: 17 Jun 2025
Submitted: 22 Jun 2025
Quarter: 2025-Q2
Submitter: n.bruun
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	98.94	% area	≥ 97.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	1.06	% area	≤ 3.0	PASS
Largest single impurity	RP-HPLC — des-AEEA semaglutide (−145 Da)	0.62	% 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	4.88	%	≤ 8.0	PASS
Counter-ion (TFA)	anion-exchange ion chromatography	11.11	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.72	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	0.63	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 powder, no defined cake (melt-back)	—	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	2.40	—	2.5 – 8.0	FAIL
Retention time (observed)	RP-HPLC, 35 min gradient	21.22	min	21.24 ± 0.45 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	0.98	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	52,710	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [D-Aib8]-diastereomer	0.74	—	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 52,710, and skew follows the reported asymmetry factor of 0.98. 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 0.62 % impurity against a 98.94 % 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	21.22	4,808,791	98.94	—
2	des-AEEA semaglutide (−145 Da)	20.26	30,134	0.62	-145.074
3	des-His1 truncate (−137 Da)	19.89	12,151	0.25	-137.059
4	C18 diacid mono-ester	22.81	5,346	0.11	+14.016
5	deamidated (Asn→Asp, +1 Da)	20.63	2,430	0.05	+0.984
6	[D-Aib8]-diastereomer	20.94	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)	98.42	98.94	divergence -0.25 pp vs batch median
Total impurities (% area)	1.58	1.06
Largest single impurity (% area)	not stated	0.62
Water (%)	3.0	4.88
Counter-ion (%)	7.4	11.11
Peptide content (%w/w)	96.5	not determined
Endotoxin (EU/mg)	not stated	0.63
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, 20 d) → laboratory (courier, ambient, 9 d) → assay.
Assay date: 17 Jun 2025
Submitted to the index: 22 Jun 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 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.

sample_vs_retail22 Jun 2025

Where a supplier-supplied result on the same lot also exists, the pair is the informative object rather than either record alone. The batch page shows whether one does.

epitalon_bAsp22 Jun 2025

A beta-aspartyl isomer sits a tenth of a minute away and is mass-identical. That is the archetype of a pair where resolution is a compound property and no rule should adjudicate it.

price_per_mg22 Jun 2025

Cost per milligram of recovered peptide, not per vial. At this salt burden the two differ by more than most catalogue price differences.

Section 7

Related records

Same batch — lot HJ-2504-Y7274 n=3

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-019947	HJ-2504-Y7274	Janoshik	2025-Q2	98.67	4.42	90.7	Buyer-sourced	1	MARGINAL
AX-2025-019948	HJ-2504-Y7274	Janoshik	2025-Q2	98.64	5.36	90.8	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 HJ records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042595	Semaglutide	HJ-2608-C7002	Janoshik	2026-Q3	99.50	3.55	—	Buyer-sourced	1	MARGINAL
AX-2026-042598	Semaglutide	HJ-2608-C7002	Janoshik	2026-Q3	99.59	3.84	—	Buyer-sourced	0	PASS
AX-2026-042605	Semaglutide	HJ-2608-C7002	Janoshik	2026-Q3	99.03	3.37	107.3	Buyer-sourced	0	PASS
AX-2026-042602	Semaglutide	HJ-2608-C7002	Nordanalyt	2026-Q3	99.21	3.50	92.0	Buyer-sourced	0	PASS
AX-2026-042603	Semaglutide	HJ-2608-C7002	Janoshik	2026-Q3	99.16	3.42	105.9	Buyer-sourced	0	PASS
AX-2026-042528	GHRP-6	HJ-2603-R5329	VendorInvestigate	2026-Q3	98.69	1.87	95.8	Buyer-sourced	0	FAIL
AX-2026-042526	GHRP-6	HJ-2603-R5329	Medutest	2026-Q3	99.37	3.06	—	Laboratory-retained	0	PASS
AX-2026-042527	GHRP-6	HJ-2603-R5329	VendorInvestigate	2026-Q3	99.21	2.77	93.2	Buyer-sourced	0	PASS