AssayIndex

AX-2025-020413

Liraglutide · 10 mg declared · Xi'an Mokemei Biotechnology Co., Ltd. · lot MKM-2508-P4928

FAILIDENTITY CONSISTENT
Report ID
AX-2025-020413
Compound
Liraglutide
Compound class
Incretin analogues and co-agonists
Supplier
MKM — Xi'an Mokemei Biotechnology Co., Ltd.
Batch / lot
MKM-2508-P4928
Declared label claim
10mg
Laboratory
Janoshik Analytical
Assay date
20 Aug 2025
Submitted
11 Sep 2025
Quarter
2025-Q3
Submitter
i.ndiaye
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.

ParameterMethodResultUnitIndex spec
PurityRP-HPLC, 30 min gradient, 214 nm97.87% area≥ 97.5PASS
Total impuritiesRP-HPLC, sum of reported peaks2.13% area≤ 2.5PASS
Largest single impurityRP-HPLC — deamidated (Asn→Asp, +1 Da)1.21% area≤ 1.00FAIL
Identity — theoretical monoisotopic masscalculated from molecular formula3748.9631Da—NOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)3748.9713Da—NOT TESTED
Mass accuracyobserved vs theoretical+2.2ppm± 15PASS
Peptide contentnot ordered on this submissionnot determined—required to check label claimNOT TESTED
Water contentKarl Fischer, coulometric, duplicate7.04%≤ 8.0PASS
Counter-ion (TFA)anion-exchange ion chromatography12.18%≤ 12.0FAIL
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.37%—NOT TESTED
Endotoxinnot ordered on this submissionnot determined—≤ 5.0NOT TESTED
Sterilitynot ordered on this submissionnot determined—no growthNOT TESTED
Appearancevisual, diffuse light, black and white backgroundWhite cake, partially collapsed—white to off-white intact cakeFAIL
Reconstitution clarityreconstituted per submitter procedureClear, colourless, no visible particulates—clear, no visible particulatesPASS
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration3.84—2.5 – 8.0PASS
Retention time (observed)RP-HPLC, 30 min gradient17.78min17.28 ± 0.40 (normalised)FAIL
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.02—0.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²67,851—≥ 20,000PASS
Resolution to nearest impurityvs γ-Glu regioisomer1.47—no index criterionREPORTED
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.

01643328749306573 Liraglutide17.78 min · 97.87 % 17.3020.6614.34 same trace · ×50 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 05101520253035 Retention time (min) Response (mAU)
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 67,851, and skew follows the reported asymmetry factor of 1.02. 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 1.21 % impurity against a 97.87 % main peak is a line two pixels tall; the main peak runs off-scale there by design.
#PeakRTArea (µV·s)% areaΔ mass (Da)
1Liraglutide — main peak17.784,756,78597.87—
2deamidated (Asn→Asp, +1 Da)17.3058,8101.21+0.984
3palmitoyl bis-adduct (+238 Da)20.6628,6760.59+238.230
4des-palmitoyl liraglutide (−238 Da)14.3410,2070.21-238.230
5γ-Glu regioisomer18.192,9160.060.000
6des-His1 truncate (−137 Da)16.761,9440.04-137.059
7liraglutide dimer20.939720.02+3748.963
Closure check — purity + Σ impurities 100.00CLOSES

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.

02550751004757501025130015751850 [M+4H]4+938.25[M+3H]3+1250.66[M+5H]5+750.80 m/z Relative abundance (%)
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 3748.9713 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.
ChargeTheoretical m/zObserved m/zΔ m/zRel. abundance (%)
6+625.8345625.83580.00138.3
5+750.7999750.80150.001656.9
4+938.2481938.25010.0020100.0
3+1250.66161250.66440.002858.1
2+1875.48881875.49290.00419.0
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.

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.

FigureSupplier COAThis reportIndex note
Purity (% area)98.2797.87divergence +0.21 pp vs batch median
Total impurities (% area)1.732.13
Largest single impurity (% area)0.621.21
Water (%)not stated7.04
Counter-ion (%)not stated12.18
Peptide content (%w/w)not statednot determined
Endotoxin (EU/mg)not statednot determined
Method stated on certificateNO—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 → submitter (−20 °C, 3 d) → laboratory (courier, dry ice, 12 d) → assay.
Assay date
20 Aug 2025
Submitted to the index
11 Sep 2025
Laboratory
Janoshik Analytical, Ostrava, Czechia
Method basis
30 min gradient · high-resolution MS
Verification status
IDENTITY CONSISTENT
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.

shipping_temp
The custody block above records the shipping conditions this vial actually experienced, which is the condition an ordinary buyer's vial experiences too. That representativeness is the point.
method_absent
A resolution figure without a stated column and gradient is uninterpretable. Both are on this record, which is why the figure is worth printing at all.
diode_array
Peak purity by spectral comparison across the main peak flags co-elution where chromatography cannot resolve it. It does not quantify the co-eluting species, but it establishes that one exists.
Section 7

Related records

Same batch — lot MKM-2508-P4928 n=10

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2025-020410MKM-2508-P4928Janoshik2025-Q398.546.54101.6Supplier-supplied2FAIL
AX-2025-020411MKM-2508-P4928Nordanalyt2025-Q397.987.00—Buyer-sourced0PASS
AX-2025-020412MKM-2508-P4928Janoshik2025-Q399.196.5493.9Supplier-supplied1MARGINAL
AX-2025-020414MKM-2508-P4928Janoshik2025-Q397.996.89103.1Buyer-sourced0PASS
AX-2025-020415MKM-2508-P4928Janoshik2025-Q398.046.65—Buyer-sourced0PASS
AX-2025-020416MKM-2508-P4928PeptideMeter2025-Q398.217.09104.9Buyer-sourced0PASS
AX-2025-020417MKM-2508-P4928Janoshik2025-Q398.167.2593.5Buyer-sourced0PASS
AX-2025-020418MKM-2508-P4928Janoshik2025-Q398.086.66—Buyer-sourced0PASS
AX-2025-020419MKM-2508-P4928PeptideMeter2025-Q397.566.8692.4Buyer-sourced0PASS

Cross-sections

Other recent Liraglutide records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041275WWBWWB-2607-X2189Nordanalyt2026-Q399.334.39—Buyer-sourced1MARGINAL
AX-2026-043295CPCCPC-2602-G9942Janoshik2026-Q397.345.17106.3Buyer-sourced0FAIL
AX-2026-041271WWBWWB-2607-X2189Medutest2026-Q399.524.5797.4Buyer-sourced1MARGINAL
AX-2026-043297CPCCPC-2602-G9942Janoshik2026-Q397.014.95103.5Buyer-sourced0FAIL
AX-2026-041273WWBWWB-2607-X2189Janoshik2026-Q399.315.52104.8Buyer-sourced1MARGINAL
AX-2026-041272WWBWWB-2607-X2189Janoshik2026-Q399.285.4397.4Buyer-sourced1MARGINAL
AX-2026-043298CPCCPC-2602-G9942VendorInvestigate2026-Q397.205.0195.4Buyer-sourced0FAIL
AX-2026-041274WWBWWB-2607-X2189Janoshik2026-Q399.264.57—Buyer-sourced1MARGINAL
Other recent MKM records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042942CJC-1295 (no DAC)MKM-2603-V3346Janoshik2026-Q399.523.43—Supplier-supplied0PASS
AX-2026-043019AdipotideMKM-2606-K5012Janoshik2026-Q397.615.77105.1Buyer-sourced0PASS
AX-2026-042939CJC-1295 (no DAC)MKM-2603-V3346PeptideMeter2026-Q399.443.39—Buyer-sourced0PASS
AX-2026-043020AdipotideMKM-2606-K5012Medutest2026-Q397.735.74—Buyer-sourced0PASS
AX-2026-043022AdipotideMKM-2606-K5012Kestrel2026-Q397.696.33106.9Buyer-sourced0PASS
AX-2026-043023AdipotideMKM-2606-K5012Medutest2026-Q397.485.56103.7Supplier-supplied0PASS
AX-2026-042945CJC-1295 (no DAC)MKM-2603-V3346PeptideMeter2026-Q399.393.54—Laboratory-retained0PASS
AX-2026-042938CJC-1295 (no DAC)MKM-2603-V3346Nordanalyt2026-Q399.473.6795.0Buyer-sourced0PASS