AssayIndex

AX-2026-042271

Liraglutide · 5 mg declared · Hunan Aslsen Technology Co., Ltd. · lot HOMO-2602-E2761

MARGINALVERIFIED
Report ID
AX-2026-042271
Compound
Liraglutide
Compound class
Incretin analogues and co-agonists
Supplier
Homopeptide — Hunan Aslsen Technology Co., Ltd.
Batch / lot
HOMO-2602-E2761
Declared label claim
5mg
Laboratory
VendorInvestigate
Assay date
07 Apr 2026
Submitted
18 Apr 2026
Quarter
2026-Q2
Submitter
r.ogunleye
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, 32 min gradient, 214 nm99.43% area≥ 97.5PASS
Total impuritiesRP-HPLC, sum of reported peaks0.57% area≤ 2.5PASS
Largest single impurityRP-HPLC — palmitoyl bis-adduct (+238 Da)0.35% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula3748.9631DaNOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)3748.9549DaNOT TESTED
Mass accuracyobserved vs theoretical-2.2ppm± 15PASS
Total peptide contentby difference from the gravimetric mass balance88.19%w/wNOT TESTED
Target-compound contenttotal peptide content × purity87.69%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen5.11mg5 mg declaredNOT TESTED
Recovered target peptidegross fill × target content4.481mg5 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim89.6%90.0 – 110.0FAIL
Water contentKarl Fischer, coulometric, duplicate4.61%≤ 8.0PASS
Counter-ion (acetate)anion-exchange ion chromatography6.86%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.34%NOT TESTED
Endotoxinnot ordered on this submissionnot determined≤ 5.0NOT TESTED
Sterilitynot ordered on this submissionnot determinedno growthNOT TESTED
Appearancevisual, diffuse light, black and white backgroundOff-white lyophilised cake, intactwhite to off-white intact cakePASS
Reconstitution clarityreconstituted per submitter procedureClear, colourless, no visible particulatesclear, no visible particulatesPASS
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration4.862.5 – 8.0PASS
Retention time (observed)RP-HPLC, 32 min gradient18.45min18.34 ± 0.40 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.050.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²73,421≥ 20,000PASS
Resolution to nearest impurityvs γ-Glu regioisomer1.57no 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.

01649329849476596 Liraglutide18.45 min · 99.43 % 21.5217.3614.78 same trace · ×200 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 05101520253035 Retention time (min) Response (mAU)
Figure 1. RP-HPLC trace, 32 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 73,421, and skew follows the reported asymmetry factor of 1.05. 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 0.35 % impurity against a 99.43 % 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 peak18.454,832,60699.43
2palmitoyl bis-adduct (+238 Da)21.5217,0110.35+238.230
3des-His1 truncate (−137 Da)17.364,8600.10-137.059
4des-palmitoyl liraglutide (−238 Da)14.783,4020.07-238.230
5γ-Glu regioisomer18.892,4300.050.000
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 3748.9549 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+625.8345625.8331-0.00148.8
5+750.7999750.7983-0.001656.1
4+938.2481938.2460-0.0021100.0
3+1250.66161250.6589-0.002759.2
2+1875.48881875.4847-0.00419.1
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.

ComponentDetermination%w/w of cake
WaterKarl Fischer4.61
Counter-ion (acetate)ion chromatography6.86
Residual solvent + inorganic residueestimated0.34
Total peptide contentby difference88.19
Total100.00 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.

FigureSupplier COAThis reportIndex note
Purity (% area)99.9099.43divergence -0.03 pp vs batch median
Total impurities (% area)0.100.57
Largest single impurity (% area)not stated0.35
Water (%)not stated4.61
Counter-ion (%)6.16.86
Peptide content (%w/w)89.888.19
Endotoxin (EU/mg)0.19not determined
Method stated on certificateYEScolumn, 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, 29 d) → laboratory (courier, dry ice, 10 d) → assay.
Assay date
07 Apr 2026
Submitted to the index
18 Apr 2026
Laboratory
VendorInvestigate, Riga, Latvia
Method basis
32 min gradient · high-resolution MS
Verification status
VERIFIED
Section 6

Annotations

No annotations on this record. Annotations are short signed technical comments from index contributors; see how to contribute.

Section 7

Related records

Same batch — lot HOMO-2602-E2761 n=8

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042265HOMO-2602-E2761PeptideMeter2026-Q299.934.01106.6Supplier-supplied0PASS
AX-2026-042266HOMO-2602-E2761Kestrel2026-Q299.934.32Supplier-supplied0PASS
AX-2026-042267HOMO-2602-E2761Janoshik2026-Q299.933.53Supplier-supplied1FAIL
AX-2026-042268HOMO-2602-E2761Medutest2026-Q299.934.32Supplier-supplied0PASS
AX-2026-042269HOMO-2602-E2761Kestrel2026-Q299.934.3490.4Supplier-supplied0PASS
AX-2026-042270HOMO-2602-E2761PeptideMeter2026-Q299.934.10101.2Supplier-supplied0PASS
AX-2026-042272HOMO-2602-E2761Janoshik2026-Q299.933.91Supplier-supplied0PASS
Other recent Liraglutide records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041275WWBWWB-2607-X2189Nordanalyt2026-Q399.615.0397.3Supplier-supplied0PASS
AX-2026-043335CPCCPC-2602-G1978Janoshik2026-Q397.294.91Laboratory-retained1FAIL
AX-2026-043332CPCCPC-2602-G1978Janoshik2026-Q397.164.8891.3Supplier-supplied1FAIL
AX-2026-041271WWBWWB-2607-X2189Medutest2026-Q399.935.2495.8Supplier-supplied0PASS
AX-2026-043336CPCCPC-2602-G1978Janoshik2026-Q397.694.58104.9Supplier-supplied1MARGINAL
AX-2026-041652QSCQSC-2605-W8602Nordanalyt2026-Q399.336.55Supplier-supplied0PASS
AX-2026-041273WWBWWB-2607-X2189Janoshik2026-Q399.874.27Supplier-supplied0PASS
AX-2026-041272WWBWWB-2607-X2189Janoshik2026-Q399.154.1297.2Supplier-supplied0PASS
Other recent Homopeptide records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042181IpamorelinHOMO-2608-A9045Janoshik2026-Q399.784.79Supplier-supplied1MARGINAL
AX-2026-042172SemaglutideHOMO-2604-X8921Janoshik2026-Q399.645.1691.9Supplier-supplied1MARGINAL
AX-2026-042278SLU-PP-332HOMO-2602-Y2822Kestrel2026-Q399.714.42Supplier-supplied0PASS
AX-2026-042180IpamorelinHOMO-2608-A9045Janoshik2026-Q399.394.74105.5Supplier-supplied1MARGINAL
AX-2026-042184IpamorelinHOMO-2608-A9045Kestrel2026-Q399.274.79103.2Supplier-supplied1MARGINAL
AX-2026-042274SLU-PP-332HOMO-2602-Y2822VendorInvestigate2026-Q398.714.72Laboratory-retained0PASS
AX-2026-042183IpamorelinHOMO-2608-A9045VendorInvestigate2026-Q399.384.97Buyer-sourced1MARGINAL
AX-2026-042194RetatrutideHOMO-2605-V9833PeptideMeter2026-Q398.904.0798.8Supplier-supplied3MARGINAL