AX-2025-019042

Liraglutide · 10 mg declared · Asymchem Laboratories (Tianjin) Co., Ltd. · lot ASY-{CAT}-2101

PASSPURITY ONLY

Report ID: AX-2025-019042
Compound: Liraglutide
Compound class: Incretin analogues and co-agonists
Supplier: ASY — Asymchem Laboratories (Tianjin) Co., Ltd.
Batch / lot: ASY-{CAT}-2101
Declared label claim: 10mg
Laboratory: Nordanalyt Laboratories
Assay date: 05 Nov 2025
Submitted: 17 Nov 2025
Quarter: 2025-Q4
Submitter: n.abubakar
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	99.86	% area	≥ 97.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.14	% area	≤ 2.5	PASS
Largest single impurity	RP-HPLC — palmitoyl bis-adduct (+238 Da)	0.09	% 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	86.06	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	85.94	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	10.79	mg	10 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	9.273	mg	10 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	92.7	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	3.41	%	≤ 8.0	PASS
Counter-ion (TFA)	anion-exchange ion chromatography	10.38	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.15	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	0.59	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, colourless, no visible particulates	—	clear, no visible particulates	PASS
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	4.48	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 35 min gradient	20.06	min	19.93 ± 0.40 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.14	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	62,260	—	≥ 20,000	PASS
Resolution to nearest impurity	vs γ-Glu regioisomer	1.45	—	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 62,260, and skew follows the reported asymmetry factor of 1.14. 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 0.09 % impurity against a 99.86 % 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	20.06	4,853,506	99.86	—
2	palmitoyl bis-adduct (+238 Da)	23.42	4,374	0.09	+238.230
3	deamidated (Asn→Asp, +1 Da)	19.50	1,944	0.04	+0.984
4	γ-Glu regioisomer	20.54	486	0.01	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.

Component	Determination	%w/w of cake
Water	Karl Fischer	3.41
Counter-ion (TFA)	ion chromatography	10.38
Residual solvent + inorganic residue	estimated	0.15
Total peptide content	by difference	86.06
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)	99.84	99.86	divergence -0.06 pp vs batch median
Total impurities (% area)	0.16	0.14
Largest single impurity (% area)	0.08	0.09
Water (%)	3.2	3.41
Counter-ion (%)	not stated	10.38
Peptide content (%w/w)	92.0	86.06
Endotoxin (EU/mg)	not stated	0.59
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 (ambient, 19 d) → laboratory (hand-carried, 8 d) → assay.
Assay date: 05 Nov 2025
Submitted to the index: 17 Nov 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.
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.

tbu_residual17 Nov 2025

Residual side-chain protection at +56 Da is the classic silent passenger on a high-purity trace. Nothing at that offset above threshold on this record.

valley_drop17 Nov 2025

Valley height relative to the smaller peak is the practical criterion an operator uses, and it is not on the report. Resolution is a proxy for it and an imperfect one on asymmetric pairs.

Section 7

Related records

Same batch — lot ASY-{CAT}-2101 n=8

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-019038	ASY-{CAT}-2101	Medutest	2025-Q4	99.93	3.61	—	Buyer-sourced	0	PASS
AX-2025-019039	ASY-{CAT}-2101	Nordanalyt	2025-Q4	99.79	3.46	—	Laboratory-retained	0	FAIL
AX-2026-041799	ASY-{CAT}-2101	Kestrel	2025-Q4	99.93	3.97	—	Buyer-sourced	0	PASS
AX-2026-041800	ASY-{CAT}-2101	Janoshik	2025-Q4	99.93	4.07	99.8	Buyer-sourced	0	PASS
AX-2025-019040	ASY-{CAT}-2101	PeptideMeter	2025-Q4	99.93	4.35	103.1	Buyer-sourced	0	PASS
AX-2025-019041	ASY-{CAT}-2101	Medutest	2025-Q4	99.87	4.20	105.9	Buyer-sourced	1	FAIL
AX-2025-019043	ASY-{CAT}-2101	Janoshik	2025-Q4	99.59	3.72	89.6	Buyer-sourced	1	MARGINAL

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 ASY records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041776	TB-500	ASY-{CAT}-2167	Janoshik	2026-Q3	99.92	4.61	98.2	Buyer-sourced	0	PASS
AX-2026-041777	TB-500	ASY-{CAT}-2167	PeptideMeter	2026-Q3	99.78	4.09	92.8	Buyer-sourced	0	PASS
AX-2026-041786	Retatrutide	ASY-{CAT}-2288	VendorInvestigate	2026-Q3	98.78	6.59	—	Buyer-sourced	0	PASS
AX-2026-041782	TB-500	ASY-{CAT}-2167	Nordanalyt	2026-Q3	99.93	3.94	—	Buyer-sourced	0	PASS
AX-2026-041793	Retatrutide	ASY-{CAT}-2288	Nordanalyt	2026-Q3	98.34	6.16	104.8	Buyer-sourced	0	PASS
AX-2026-041784	Retatrutide	ASY-{CAT}-2288	PeptideMeter	2026-Q3	98.15	6.26	91.9	Buyer-sourced	0	PASS
AX-2026-041774	TB-500	ASY-{CAT}-2167	PeptideMeter	2026-Q3	99.93	4.41	96.2	Buyer-sourced	0	PASS
AX-2026-041780	TB-500	ASY-{CAT}-2167	Janoshik	2026-Q3	99.93	3.48	102.5	Buyer-sourced	1	FAIL