AX-2026-042908

Liraglutide · 15 mg declared · Nantong Guangyuan Chemical Co., Ltd. · lot GGPE-2510-C2712

PASSPURITY ONLY

Report ID: AX-2026-042908
Compound: Liraglutide
Compound class: Incretin analogues and co-agonists
Supplier: GGPeps — Nantong Guangyuan Chemical Co., Ltd.
Batch / lot: GGPE-2510-C2712
Declared label claim: 15mg
Laboratory: Janoshik Analytical
Assay date: 15 Mar 2026
Submitted: 22 Mar 2026
Quarter: 2026-Q1
Submitter: Contributor #Z-8462
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, 30 min gradient, 214 nm	98.76	% area	≥ 97.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	1.24	% area	≤ 2.5	PASS
Largest single impurity	RP-HPLC — deamidated (Asn→Asp, +1 Da)	0.69	% 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	88.95	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	87.85	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	17.46	mg	15 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	15.339	mg	15 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	102.3	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	4.79	%	≤ 8.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	5.27	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.99	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	0.46	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 lyophilised cake, intact	—	white to off-white intact cake	PASS
Reconstitution clarity	reconstituted per submitter procedure	Clear with a single visible fibre	—	clear, no visible particulates	FAIL
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	4.50	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	17.09	min	17.28 ± 0.40 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	0.99	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	58,459	—	≥ 20,000	PASS
Resolution to nearest impurity	vs γ-Glu regioisomer	1.41	—	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 58,459, and skew follows the reported asymmetry factor of 0.99. 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 0.69 % impurity against a 98.76 % 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	Liraglutide — main peak	17.09	4,800,042	98.76	—
2	deamidated (Asn→Asp, +1 Da)	16.61	33,536	0.69	+0.984
3	γ-Glu regioisomer	17.50	18,955	0.39	0.000
4	des-palmitoyl liraglutide (−238 Da)	13.65	3,402	0.07	-238.230
5	des-His1 truncate (−137 Da)	16.07	2,430	0.05	-137.059
6	palmitoyl bis-adduct (+238 Da)	19.97	1,458	0.03	+238.230
7	liraglutide dimer	20.24	486	0.01	+3748.963
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	4.79
Counter-ion (acetate)	ion chromatography	5.27
Residual solvent + inorganic residue	estimated	0.99
Total peptide content	by difference	88.95
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)	99.05	98.76	divergence +0.32 pp vs batch median
Total impurities (% area)	0.95	1.24
Largest single impurity (% area)	0.36	0.69
Water (%)	2.7	4.79
Counter-ion (%)	not stated	5.27
Peptide content (%w/w)	not stated	88.95
Endotoxin (EU/mg)	not stated	0.46
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 → third-party forwarder (32 d) → laboratory (courier, cold pack, 11 d) → assay.
Assay date: 15 Mar 2026
Submitted to the index: 22 Mar 2026
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 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 2

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.

buyer_sourced22 Mar 2026

Independently purchased, at the submitter's own cost, forwarded without the supplier's involvement. That is the definition and this record meets it.

sole_source22 Mar 2026

On compounds with a single supplier, independently purchased records are the only thing preventing the evidence base from being entirely supplier-generated. They matter disproportionately there.

Section 7

Related records

Same batch — lot GGPE-2510-C2712 n=5

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042904	GGPE-2510-C2712	VendorInvestigate	2026-Q1	99.05	5.09	105.6	Buyer-sourced	0	PASS
AX-2026-042905	GGPE-2510-C2712	PeptideMeter	2026-Q1	98.73	4.20	101.3	Buyer-sourced	1	MARGINAL
AX-2026-042906	GGPE-2510-C2712	Janoshik	2026-Q1	98.67	5.02	97.2	Buyer-sourced	0	PASS
AX-2026-042907	GGPE-2510-C2712	Nordanalyt	2026-Q1	98.51	4.92	—	Buyer-sourced	0	PASS

Batch rollup and reproducibility assessment →

Cross-sections

Other recent Liraglutide records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041275	WWB	WWB-2607-X2189	Nordanalyt	2026-Q3	99.33	4.39	—	Buyer-sourced	1	MARGINAL
AX-2026-043295	CPC	CPC-2602-G9942	Janoshik	2026-Q3	97.34	5.17	106.3	Buyer-sourced	0	FAIL
AX-2026-041271	WWB	WWB-2607-X2189	Medutest	2026-Q3	99.52	4.57	97.4	Buyer-sourced	1	MARGINAL
AX-2026-043297	CPC	CPC-2602-G9942	Janoshik	2026-Q3	97.01	4.95	103.5	Buyer-sourced	0	FAIL
AX-2026-041273	WWB	WWB-2607-X2189	Janoshik	2026-Q3	99.31	5.52	104.8	Buyer-sourced	1	MARGINAL
AX-2026-041272	WWB	WWB-2607-X2189	Janoshik	2026-Q3	99.28	5.43	97.4	Buyer-sourced	1	MARGINAL
AX-2026-043298	CPC	CPC-2602-G9942	VendorInvestigate	2026-Q3	97.20	5.01	95.4	Buyer-sourced	0	FAIL
AX-2026-041274	WWB	WWB-2607-X2189	Janoshik	2026-Q3	99.26	4.57	—	Buyer-sourced	1	MARGINAL

Other recent GGPeps records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2026-042784	CJC-1295 (no DAC)	GGPE-2606-E1234	Medutest	2026-Q3	98.27	4.55	—	Buyer-sourced	PASS
AX-2026-042786	CJC-1295 (no DAC)	GGPE-2606-E1234	Janoshik	2026-Q3	98.22	3.77	—	Buyer-sourced	PASS
AX-2026-042858	Selank	GGPE-2603-J2447	VendorInvestigate	2026-Q3	98.87	8.85	99.4	Buyer-sourced	FAIL
AX-2026-042783	CJC-1295 (no DAC)	GGPE-2606-E1234	Janoshik	2026-Q3	98.22	4.45	90.6	Buyer-sourced	PASS
AX-2026-042757	Melanotan II	GGPE-2603-P1474	Janoshik	2026-Q3	99.54	6.78	92.0	Buyer-sourced	PASS
AX-2026-042785	CJC-1295 (no DAC)	GGPE-2606-E1234	PeptideMeter	2026-Q3	97.70	4.64	91.4	Buyer-sourced	FAIL
AX-2026-042756	Melanotan II	GGPE-2603-P1474	Nordanalyt	2026-Q3	99.17	7.04	—	Buyer-sourced	PASS
AX-2026-042755	Melanotan II	GGPE-2603-P1474	Nordanalyt	2026-Q3	99.25	6.58	90.4	Buyer-sourced	PASS