AX-2024-004220

Liraglutide · 15 mg declared · Wuhan Wansheng Biotechnology Co., Ltd. · lot WWB-2406-R3462

MARGINALVERIFIED

Report ID: AX-2024-004220
Compound: Liraglutide
Compound class: Incretin analogues and co-agonists
Supplier: WWB — Wuhan Wansheng Biotechnology Co., Ltd.
Batch / lot: WWB-2406-R3462
Declared label claim: 15mg
Laboratory: Nordanalyt Laboratories
Assay date: 13 Jul 2024
Submitted: 05 Aug 2024
Quarter: 2024-Q3
Submitter: t.nakamura
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	99.28	% area	≥ 97.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.72	% area	≤ 2.5	PASS
Largest single impurity	RP-HPLC — des-palmitoyl liraglutide (−238 Da)	0.47	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	3748.9631	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, high resolution (ESI-TOF/QTOF)	3748.9732	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+2.7	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	92.29	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	91.63	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	16.22	mg	15 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	14.862	mg	15 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	99.1	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	2.63	%	≤ 8.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	4.71	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.37	%	—	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 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	5.76	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 35 min gradient	19.30	min	19.93 ± 0.40 (normalised)	FAIL
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.10	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	56,399	—	≥ 20,000	PASS
Resolution to nearest impurity	vs γ-Glu regioisomer	1.44	—	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 56,399, and skew follows the reported asymmetry factor of 1.10. 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 0.47 % impurity against a 99.28 % 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	19.30	4,825,316	99.28	—
2	des-palmitoyl liraglutide (−238 Da)	15.29	22,843	0.47	-238.230
3	palmitoyl bis-adduct (+238 Da)	22.66	7,776	0.16	+238.230
4	γ-Glu regioisomer	19.78	1,944	0.04	0.000
5	des-His1 truncate (−137 Da)	18.11	1,458	0.03	-137.059
6	deamidated (Asn→Asp, +1 Da)	18.74	972	0.02	+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 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 3748.9732 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	625.8361	0.0016	7.8
5+	750.7999	750.8019	0.0020	55.7
4+	938.2481	938.2506	0.0025	100.0
3+	1250.6616	1250.6650	0.0034	56.6
2+	1875.4888	1875.4939	0.0051	7.6

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	2.63
Counter-ion (acetate)	ion chromatography	4.71
Residual solvent + inorganic residue	estimated	0.37
Total peptide content	by difference	92.29
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)	99.25	99.28	divergence -0.10 pp vs batch median
Total impurities (% area)	0.75	0.72
Largest single impurity (% area)	not stated	0.47
Water (%)	0.4	2.63
Counter-ion (%)	4.5	4.71
Peptide content (%w/w)	94.5	92.29
Endotoxin (EU/mg)	not stated	not determined
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 (−20 °C, 25 d) → laboratory (courier, dry ice, 9 d) → assay.
Assay date: 13 Jul 2024
Submitted to the index: 05 Aug 2024
Laboratory: Nordanalyt Laboratories, Uppsala, Sweden
Method basis: 35 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 3

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.

sodium_adduct05 Aug 2024

Adduct bookkeeping on this one is tidy. The sodium series is present at the expected intensity ratio and has not been counted as an impurity, which happens more often than it should.

buyer_sourced05 Aug 2024

No relationship between submitter and supplier is declared on this record, and the contributor register holds none. That is the default and it is what the provenance class asserts.

peak_integrator05 Aug 2024

Resolution to the nearest named impurity is reported on this record with no verdict attached, which is the correct handling. A threshold on that figure would penalise compounds for their own impurity profiles.

Section 7

Related records

Same batch — lot WWB-2406-R3462 n=13

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2024-004215	WWB-2406-R3462	Janoshik	2024-Q3	99.30	2.57	—	Buyer-sourced	0	PASS
AX-2024-004216	WWB-2406-R3462	VendorInvestigate	2024-Q3	99.07	1.34	97.3	Buyer-sourced	0	PASS
AX-2024-004217	WWB-2406-R3462	Janoshik	2024-Q3	99.28	2.58	101.4	Laboratory-retained	1	FAIL
AX-2024-004218	WWB-2406-R3462	Medutest	2024-Q3	99.67	2.69	98.6	Buyer-sourced	0	PASS
AX-2024-004219	WWB-2406-R3462	Medutest	2024-Q3	99.93	2.51	91.1	Laboratory-retained	0	PASS
AX-2024-004221	WWB-2406-R3462	Janoshik	2024-Q3	99.58	2.23	96.0	Buyer-sourced	0	PASS
AX-2024-004222	WWB-2406-R3462	PeptideMeter	2024-Q3	99.77	1.39	—	Buyer-sourced	0	PASS
AX-2024-004223	WWB-2406-R3462	PeptideMeter	2024-Q3	99.34	1.92	—	Buyer-sourced	0	PASS
AX-2024-004224	WWB-2406-R3462	Medutest	2024-Q3	98.87	2.45	—	Buyer-sourced	1	FAIL
AX-2024-004225	WWB-2406-R3462	Kestrel	2024-Q3	99.93	2.37	96.6	Buyer-sourced	0	PASS
AX-2024-004226	WWB-2406-R3462	Nordanalyt	2024-Q3	99.40	3.00	100.3	Buyer-sourced	0	PASS
AX-2024-004227	WWB-2406-R3462	Medutest	2024-Q3	99.35	2.46	93.3	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 WWB records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041275	Liraglutide	WWB-2607-X2189	Nordanalyt	2026-Q3	99.33	4.39	—	Buyer-sourced	1	MARGINAL
AX-2026-041334	Semaglutide	WWB-2606-N3192	Janoshik	2026-Q3	98.93	4.62	99.9	Buyer-sourced	0	PASS
AX-2026-041337	Semaglutide	WWB-2606-N3192	Nordanalyt	2026-Q3	99.52	3.92	—	Buyer-sourced	0	PASS
AX-2026-041335	Semaglutide	WWB-2606-N3192	Janoshik	2026-Q3	99.15	4.27	98.9	Buyer-sourced	0	PASS
AX-2026-041271	Liraglutide	WWB-2607-X2189	Medutest	2026-Q3	99.52	4.57	97.4	Buyer-sourced	1	MARGINAL
AX-2026-041328	Semaglutide	WWB-2606-N3192	Janoshik	2026-Q3	98.99	4.47	106.1	Buyer-sourced	0	PASS
AX-2026-041333	Semaglutide	WWB-2606-N3192	Janoshik	2026-Q3	99.18	4.51	90.4	Laboratory-retained	0	PASS
AX-2026-041273	Liraglutide	WWB-2607-X2189	Janoshik	2026-Q3	99.31	5.52	104.8	Buyer-sourced	1	MARGINAL