AX-2025-019041 · Liraglutide · ASY lot ASY-{CAT}-2101

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, 25 min gradient, 214 nm	99.87	% area	≥ 97.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.13	% area	≤ 2.5	PASS
Largest single impurity	RP-HPLC — des-His1 truncate (−137 Da)	0.06	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	3748.9631	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, unit resolution (single quadrupole)	3748.8967	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	-17.7	ppm	± 15	FAIL
Total peptide content	by difference from the gravimetric mass balance	83.57	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	83.46	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	12.69	mg	10 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	10.591	mg	10 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	105.9	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	4.20	%	≤ 8.0	PASS
Counter-ion (TFA)	anion-exchange ion chromatography	11.74	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.49	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	1.13	EU/mg	≤ 5.0	PASS
Sterility	membrane filtration, USP <71>, 14 d	No growth at 14 d	—	no growth	PASS
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	Clear with a single visible fibre	—	clear, no visible particulates	FAIL
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	4.40	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 25 min gradient	14.58	min	14.63 ± 0.40 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.37	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	47,028	—	≥ 20,000	PASS
Resolution to nearest impurity	vs des-His1 truncate (−137 Da)	3.08	—	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, 25 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 47,028, and skew follows the reported asymmetry factor of 1.37. 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 0.06 % impurity against a 99.87 % 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	14.58	4,853,992	99.87	—
2	des-His1 truncate (−137 Da)	13.73	2,916	0.06	-137.059
3	liraglutide dimer	17.20	1,944	0.04	+3748.963
4	des-palmitoyl liraglutide (−238 Da)	11.71	1,458	0.03	-238.230
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 3748.9631 Da, computed from C172H265N43O51. All ppm figures on this site are against monoisotopic values — see why that matters.

Figure 2. ESI charge-state envelope, unit-resolution instrument. Sticks are placed at m/z = (M + z × 1.007276)/z for the observed neutral mass of 3748.8967 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+	625.8345	625.8234	-0.0111	8.0
5+	750.7999	750.7866	-0.0133	53.2
4+	938.2481	938.2315	-0.0166	100.0
3+	1250.6616	1250.6395	-0.0221	50.6
2+	1875.4888	1875.4556	-0.0332	8.3

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	4.20
Counter-ion (TFA)	ion chromatography	11.74
Residual solvent + inorganic residue	estimated	0.49
Total peptide content	by difference	83.57
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	99.87	divergence -0.06 pp vs batch median
Total impurities (% area)	0.16	0.13
Largest single impurity (% area)	0.08	0.06
Water (%)	3.2	4.20
Counter-ion (%)	not stated	11.74
Peptide content (%w/w)	92.0	83.57
Endotoxin (EU/mg)	not stated	1.13
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, 3 d) → laboratory (courier, cold pack, 10 d) → assay.
Assay date: 27 Oct 2025
Submitted to the index: 03 Nov 2025
Laboratory: Medutest, Ljubljana, Slovenia
Method basis: 25 min gradient · unit-resolution MS
Verification status: IDENTITY CONSISTENT

What this report does not establish

That the compound is not a near-isobaric alternative. Identity was confirmed at unit mass resolution, which cannot exclude species differing by 1 or 2 Da. The specific alternatives not excluded are named in the identity block above.
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 5

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.

retest_date03 Nov 2025

A retest date on the certificate would tell you what the supplier is actually asserting about stability. Purity at 99.87 % on assay day is a starting condition, not a shelf life.

isotope_cluster03 Nov 2025

At this mass the monoisotopic peak may not be the most intense peak in the cluster. Picking the apex instead of the monoisotopic peak produces a systematic positive error of roughly the size flagged here.

chain_custody03 Nov 2025

Custody from checkout to injection is documented on this record. Provenance plus custody is what makes a single result generalise past the vial it came from.

dedupe_logic03 Nov 2025

Two retail purchases of the same lot from different buyers are genuinely independent. Two aliquots of one purchase are not, and the index does not treat them as such.

digit_preference03 Nov 2025

Fair.

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-2025-019042	ASY-{CAT}-2101	Nordanalyt	2025-Q4	99.86	3.41	92.7	Buyer-sourced	0	PASS
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