AX-2024-005030

Semaglutide · 10 mg declared · Nantong Guangyuan Chemical Co., Ltd. · lot GGPE-2410-L1879

MARGINALPURITY ONLY

Report ID: AX-2024-005030
Compound: Semaglutide
Compound class: Incretin analogues and co-agonists
Supplier: GGPeps — Nantong Guangyuan Chemical Co., Ltd.
Batch / lot: GGPE-2410-L1879
Declared label claim: 10mg
Laboratory: Janoshik Analytical
Assay date: 15 Dec 2024
Submitted: 22 Dec 2024
Quarter: 2024-Q4
Submitter: b.mensa
Sample provenance: Supplier-supplied

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	98.77	% area	≥ 97.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	1.23	% area	≤ 3.0	PASS
Largest single impurity	RP-HPLC — des-AEEA semaglutide (−145 Da)	0.80	% 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	86.74	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	85.67	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	10.68	mg	10 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	9.150	mg	10 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	91.5	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	3.90	%	≤ 8.0	PASS
Counter-ion (TFA)	anion-exchange ion chromatography	8.42	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.94	%	—	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	3.23	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	18.53	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	82,703	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [D-Aib8]-diastereomer	0.91	—	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 82,703, 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 0.80 % impurity against a 98.77 % 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	18.53	4,800,528	98.77	—
2	des-AEEA semaglutide (−145 Da)	17.71	38,882	0.80	-145.074
3	[D-Aib8]-diastereomer	18.29	10,207	0.21	0.000
4	des-His1 truncate (−137 Da)	17.39	5,346	0.11	-137.059
5	Met(O) sulfoxide (+16 Da)	17.85	2,430	0.05	+15.995
6	C18 diacid mono-ester	19.89	1,458	0.03	+14.016
7	deamidated (Asn→Asp, +1 Da)	18.02	1,458	0.03	+0.984
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	3.90
Counter-ion (TFA)	ion chromatography	8.42
Residual solvent + inorganic residue	estimated	0.94
Total peptide content	by difference	86.74
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)	98.66	98.77	divergence +0.13 pp vs batch median
Total impurities (% area)	1.34	1.23
Largest single impurity (% area)	not stated	0.80
Water (%)	not stated	3.90
Counter-ion (%)	not stated	8.42
Peptide content (%w/w)	91.7	86.74
Endotoxin (EU/mg)	1.74	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: Supplier-supplied
Evidentiary weight: Weaker evidence. Read with the caveat below.
Chain of custody: Supplier despatch → laboratory direct (courier, cold pack, 12 d) → assay. Submitter did not handle the vial.
Assay date: 15 Dec 2024
Submitted to the index: 22 Dec 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

No annotations on this record. Annotations are short signed technical comments from index contributors; see how to contribute.

Section 7

Related records

Same batch — lot GGPE-2410-L1879 n=5

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2024-005027	GGPE-2410-L1879	Janoshik	2024-Q4	98.75	4.71	99.3	Supplier-supplied	2	MARGINAL
AX-2024-005028	GGPE-2410-L1879	Janoshik	2024-Q4	98.53	4.04	—	Supplier-supplied	1	MARGINAL
AX-2024-005029	GGPE-2410-L1879	Medutest	2024-Q4	98.22	4.03	91.5	Supplier-supplied	1	MARGINAL
AX-2024-005031	GGPE-2410-L1879	Janoshik	2024-Q4	98.25	3.75	101.1	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-2026-041334	WWB	WWB-2606-N3192	Janoshik	2026-Q3	98.83	5.04	—	Supplier-supplied	1	MARGINAL
AX-2026-041932	TFC	TFC-2604-X4301	Janoshik	2026-Q3	98.88	4.31	—	Supplier-supplied	0	PASS
AX-2026-042347	HJ	HJ-2608-C3931	VendorInvestigate	2026-Q3	98.80	3.41	100.2	Buyer-sourced	1	MARGINAL
AX-2026-041886	JEEP	JEEP-2607-X3911	Nordanalyt	2026-Q3	99.19	4.03	96.4	Supplier-supplied	2	MARGINAL
AX-2026-041337	WWB	WWB-2606-N3192	Nordanalyt	2026-Q3	98.96	4.81	—	Supplier-supplied	1	MARGINAL
AX-2026-042172	Homopeptide	HOMO-2604-X8921	Janoshik	2026-Q3	99.64	5.16	91.9	Supplier-supplied	1	MARGINAL
AX-2026-041767	FGP	FGP-2602-M1508	PeptideMeter	2026-Q3	98.65	2.54	—	Supplier-supplied	2	FAIL
AX-2026-041882	JEEP	JEEP-2607-X3911	Nordanalyt	2026-Q3	99.17	4.52	—	Supplier-supplied	1	MARGINAL

Other recent GGPeps records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042737	Selank	GGPE-2603-J9708	Janoshik	2026-Q3	98.40	9.14	97.4	Buyer-sourced	0	FAIL
AX-2026-042804	Selank	GGPE-2602-G2056	Janoshik	2026-Q3	98.50	7.97	—	Supplier-supplied	0	FAIL
AX-2026-042803	Selank	GGPE-2602-G2056	Janoshik	2026-Q3	98.48	8.01	—	Laboratory-retained	1	FAIL
AX-2026-042802	Selank	GGPE-2602-G2056	Janoshik	2026-Q3	98.74	7.09	96.0	Supplier-supplied	0	FAIL
AX-2026-042796	Selank	GGPE-2602-G2056	Janoshik	2026-Q3	98.26	7.56	97.5	Buyer-sourced	0	FAIL
AX-2026-042648	Melanotan II	GGPE-2603-P8735	Janoshik	2026-Q3	99.10	6.97	—	Supplier-supplied	4	MARGINAL
AX-2026-042797	Selank	GGPE-2602-G2056	Medutest	2026-Q3	98.46	7.92	—	Buyer-sourced	0	FAIL
AX-2026-042669	CJC-1295 (no DAC)	GGPE-2606-E8495	Medutest	2026-Q3	98.61	4.06	95.5	Supplier-supplied	0	PASS