AX-2025-020414 · Liraglutide · MKM lot MKM-2508-P4928

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	97.99	% area	≥ 97.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	2.01	% area	≤ 2.5	PASS
Largest single impurity	RP-HPLC — deamidated (Asn→Asp, +1 Da)	1.44	% area	≤ 1.00	FAIL
Identity — theoretical monoisotopic mass	calculated from molecular formula	3748.9631	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, high resolution (ESI-TOF/QTOF)	3748.9609	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	-0.6	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	83.20	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	81.53	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	12.65	mg	10 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	10.314	mg	10 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	103.1	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	6.89	%	≤ 8.0	PASS
Counter-ion (TFA)	anion-exchange ion chromatography	9.59	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.32	%	—	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	White cake, partial shrinkage from vial wall	—	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	3.15	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	17.12	min	17.28 ± 0.40 (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	50,523	—	≥ 20,000	PASS
Resolution to nearest impurity	vs γ-Glu regioisomer	1.31	—	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 50,523, 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 1.44 % impurity against a 97.99 % 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	17.12	4,762,618	97.99	—
2	deamidated (Asn→Asp, +1 Da)	16.64	69,988	1.44	+0.984
3	palmitoyl bis-adduct (+238 Da)	20.00	18,955	0.39	+238.230
4	des-palmitoyl liraglutide (−238 Da)	13.68	4,374	0.09	-238.230
5	γ-Glu regioisomer	17.53	2,916	0.06	0.000
6	liraglutide dimer	20.27	972	0.02	+3748.963
7	des-His1 truncate (−137 Da)	16.10	486	0.01	-137.059
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, high-resolution instrument. Sticks are placed at m/z = (M + z × 1.007276)/z for the observed neutral mass of 3748.9609 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	625.8341	-0.0004	8.3
5+	750.7999	750.7995	-0.0004	59.9
4+	938.2481	938.2475	-0.0006	100.0
3+	1250.6616	1250.6609	-0.0007	57.0
2+	1875.4888	1875.4877	-0.0011	8.7

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	6.89
Counter-ion (TFA)	ion chromatography	9.59
Residual solvent + inorganic residue	estimated	0.32
Total peptide content	by difference	83.20
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)	98.27	97.99	divergence +0.21 pp vs batch median
Total impurities (% area)	1.73	2.01
Largest single impurity (% area)	0.62	1.44
Water (%)	not stated	6.89
Counter-ion (%)	not stated	9.59
Peptide content (%w/w)	not stated	83.20
Endotoxin (EU/mg)	not stated	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: Buyer-sourced
Evidentiary weight: Strongest available evidence in this index.
Chain of custody: Retail purchase → third-party forwarder (9 d) → laboratory (courier, cold pack, 9 d) → assay.
Assay date: 26 Aug 2025
Submitted to the index: 14 Sep 2025
Laboratory: Janoshik Analytical, Ostrava, Czechia
Method basis: 30 min gradient · high-resolution MS
Verification status: VERIFIED

What this report does not establish

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 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.

mass_defect14 Sep 2025

Identity confirmed and purity at 97.99 %. The two answer different questions — what it is, and how much else is in it — and a record carrying both is the version worth citing.

quad_unit14 Sep 2025

Instrument class is on the record, which is what allows -0.6 ppm to be read at its proper weight. The index distinguishes "confirmed" from "consistent with" precisely on this field.

Section 7

Related records

Same batch — lot MKM-2508-P4928 n=10

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-020410	MKM-2508-P4928	Janoshik	2025-Q3	98.54	6.54	101.6	Supplier-supplied	2	FAIL
AX-2025-020411	MKM-2508-P4928	Nordanalyt	2025-Q3	97.98	7.00	—	Buyer-sourced	0	PASS
AX-2025-020412	MKM-2508-P4928	Janoshik	2025-Q3	99.19	6.54	93.9	Supplier-supplied	1	MARGINAL
AX-2025-020413	MKM-2508-P4928	Janoshik	2025-Q3	97.87	7.04	—	Buyer-sourced	1	FAIL
AX-2025-020415	MKM-2508-P4928	Janoshik	2025-Q3	98.04	6.65	—	Buyer-sourced	0	PASS
AX-2025-020416	MKM-2508-P4928	PeptideMeter	2025-Q3	98.21	7.09	104.9	Buyer-sourced	0	PASS
AX-2025-020417	MKM-2508-P4928	Janoshik	2025-Q3	98.16	7.25	93.5	Buyer-sourced	0	PASS
AX-2025-020418	MKM-2508-P4928	Janoshik	2025-Q3	98.08	6.66	—	Buyer-sourced	0	PASS
AX-2025-020419	MKM-2508-P4928	PeptideMeter	2025-Q3	97.56	6.86	92.4	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 MKM records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2026-042942	CJC-1295 (no DAC)	MKM-2603-V3346	Janoshik	2026-Q3	99.52	3.43	—	Supplier-supplied	PASS
AX-2026-043019	Adipotide	MKM-2606-K5012	Janoshik	2026-Q3	97.61	5.77	105.1	Buyer-sourced	PASS
AX-2026-042939	CJC-1295 (no DAC)	MKM-2603-V3346	PeptideMeter	2026-Q3	99.44	3.39	—	Buyer-sourced	PASS
AX-2026-043020	Adipotide	MKM-2606-K5012	Medutest	2026-Q3	97.73	5.74	—	Buyer-sourced	PASS
AX-2026-043022	Adipotide	MKM-2606-K5012	Kestrel	2026-Q3	97.69	6.33	106.9	Buyer-sourced	PASS
AX-2026-043023	Adipotide	MKM-2606-K5012	Medutest	2026-Q3	97.48	5.56	103.7	Supplier-supplied	PASS
AX-2026-042945	CJC-1295 (no DAC)	MKM-2603-V3346	PeptideMeter	2026-Q3	99.39	3.54	—	Laboratory-retained	PASS
AX-2026-042938	CJC-1295 (no DAC)	MKM-2603-V3346	Nordanalyt	2026-Q3	99.47	3.67	95.0	Buyer-sourced	PASS