AssayIndex

AX-2025-020281

Liraglutide · 15 mg declared · Nantong Guangyuan Chemical Co., Ltd. · lot GGPE-2505-W2368

MARGINALVERIFIED
Report ID
AX-2025-020281
Compound
Liraglutide
Compound class
Incretin analogues and co-agonists
Supplier
GGPeps — Nantong Guangyuan Chemical Co., Ltd.
Batch / lot
GGPE-2505-W2368
Declared label claim
15mg
Laboratory
Janoshik Analytical
Assay date
08 Oct 2025
Submitted
23 Oct 2025
Quarter
2025-Q4
Submitter
ru.villalobos
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 nm98.65% area≥ 97.5PASS
Total impuritiesRP-HPLC, sum of reported peaks1.35% area≤ 2.5PASS
Largest single impurityRP-HPLC — des-palmitoyl liraglutide (−238 Da)0.62% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula3748.9631Da—NOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)3748.9537Da—NOT TESTED
Mass accuracyobserved vs theoretical-2.5ppm± 15PASS
Total peptide contentby difference from the gravimetric mass balance85.79%w/w—NOT TESTED
Target-compound contenttotal peptide content × purity84.63%w/w—NOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen16.77mg15 mg declaredNOT TESTED
Recovered target peptidegross fill × target content14.192mg15 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim94.6%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate6.98%≤ 8.0PASS
Counter-ion (acetate)anion-exchange ion chromatography6.46%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.77%—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 lyophilised cake, intact—white to off-white intact cakePASS
Reconstitution clarityreconstituted per submitter procedureFaint haze, clearing on standing—clear, no visible particulatesFAIL
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration5.15—2.5 – 8.0PASS
Retention time (observed)RP-HPLC, 30 min gradient17.19min17.28 ± 0.40 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.21—0.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²49,252—≥ 20,000PASS
Resolution to nearest impurityvs γ-Glu regioisomer1.29—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.

01334266840035337 Liraglutide17.19 min · 98.65 % 13.7517.6020.07 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 49,252, and skew follows the reported asymmetry factor of 1.21. 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 0.62 % impurity against a 98.65 % 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 peak17.194,794,69698.65—
2des-palmitoyl liraglutide (−238 Da)13.7530,1340.62-238.230
3γ-Glu regioisomer17.6023,3290.480.000
4deamidated (Asn→Asp, +1 Da)16.715,3460.11+0.984
5palmitoyl bis-adduct (+238 Da)20.072,9160.06+238.230
6liraglutide dimer20.342,4300.05+3748.963
7des-His1 truncate (−137 Da)16.171,4580.03-137.059
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+5H]5+750.80[M+3H]3+1250.66 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 3748.9537 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+625.8345625.8329-0.00168.9
5+750.7999750.7980-0.001959.2
4+938.2481938.2457-0.0024100.0
3+1250.66161250.6585-0.003159.2
2+1875.48881875.4841-0.00478.9
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 Fischer6.98
Counter-ion (acetate)ion chromatography6.46
Residual solvent + inorganic residueestimated0.77
Total peptide contentby difference85.79
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)99.0398.65divergence +0.23 pp vs batch median
Total impurities (% area)not stated1.35
Largest single impurity (% area)not stated0.62
Water (%)6.96.98
Counter-ion (%)not stated6.46
Peptide content (%w/w)88.385.79
Endotoxin (EU/mg)0.24not determined
Method stated on certificateYES—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 (2–8 °C, 11 d) → laboratory (courier, ambient, 5 d) → assay.
Assay date
08 Oct 2025
Submitted to the index
23 Oct 2025
Laboratory
Janoshik Analytical, Ostrava, Czechia
Method basis
30 min gradient · high-resolution MS
Verification status
VERIFIED
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.

ms_confirm
Two instruments or it is not confirmed, and this record is one instrument. It is a good one instrument, and the index records it as confirmed rather than corroborated for that reason.
ash_sulfated
Sulfated ash would split the inorganic remainder out of the residual slot. It is cheap, orthogonal, and would tighten this balance from good to complete.
Section 7

Related records

Same batch — lot GGPE-2505-W2368 n=11

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2025-020275GGPE-2505-W2368Medutest2025-Q498.977.6089.6Buyer-sourced2MARGINAL
AX-2025-020276GGPE-2505-W2368Janoshik2025-Q498.626.89—Buyer-sourced1MARGINAL
AX-2026-042818GGPE-2505-W2368Janoshik2025-Q498.837.56—Buyer-sourced1MARGINAL
AX-2025-020277GGPE-2505-W2368Medutest2025-Q499.787.47—Supplier-supplied2MARGINAL
AX-2025-020278GGPE-2505-W2368Nordanalyt2025-Q498.677.39—Buyer-sourced1MARGINAL
AX-2025-020279GGPE-2505-W2368PeptideMeter2025-Q498.747.48—Buyer-sourced1MARGINAL
AX-2025-020280GGPE-2505-W2368Janoshik2025-Q498.797.2696.7Buyer-sourced1MARGINAL
AX-2025-020282GGPE-2505-W2368Janoshik2025-Q498.957.6791.0Buyer-sourced1MARGINAL
AX-2025-020283GGPE-2505-W2368Janoshik2025-Q499.017.52—Buyer-sourced1MARGINAL
AX-2025-020284GGPE-2505-W2368Medutest2025-Q498.807.51—Buyer-sourced1MARGINAL

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 GGPeps records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042784CJC-1295 (no DAC)GGPE-2606-E1234Medutest2026-Q398.274.55—Buyer-sourced0PASS
AX-2026-042786CJC-1295 (no DAC)GGPE-2606-E1234Janoshik2026-Q398.223.77—Buyer-sourced0PASS
AX-2026-042858SelankGGPE-2603-J2447VendorInvestigate2026-Q398.878.8599.4Buyer-sourced0FAIL
AX-2026-042783CJC-1295 (no DAC)GGPE-2606-E1234Janoshik2026-Q398.224.4590.6Buyer-sourced0PASS
AX-2026-042757Melanotan IIGGPE-2603-P1474Janoshik2026-Q399.546.7892.0Buyer-sourced0PASS
AX-2026-042785CJC-1295 (no DAC)GGPE-2606-E1234PeptideMeter2026-Q397.704.6491.4Buyer-sourced0FAIL
AX-2026-042756Melanotan IIGGPE-2603-P1474Nordanalyt2026-Q399.177.04—Buyer-sourced0PASS
AX-2026-042755Melanotan IIGGPE-2603-P1474Nordanalyt2026-Q399.256.5890.4Buyer-sourced0PASS