AssayIndex

AX-2025-019843

Semaglutide · 10 mg declared · Hunan Aslsen Technology Co., Ltd. · lot HOMO-2506-M5731

MARGINALVERIFIED
Report ID
AX-2025-019843
Compound
Semaglutide
Compound class
Incretin analogues and co-agonists
Supplier
Homopeptide — Hunan Aslsen Technology Co., Ltd.
Batch / lot
HOMO-2506-M5731
Declared label claim
10mg
Laboratory
Janoshik Analytical
Assay date
05 Sep 2025
Submitted
14 Sep 2025
Quarter
2025-Q3
Submitter
c.okonkwo
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 nm97.85% area≥ 97.0PASS
Total impuritiesRP-HPLC, sum of reported peaks2.15% area≤ 3.0PASS
Largest single impurityRP-HPLC — deamidated (Asn→Asp, +1 Da)1.52% area≤ 1.00FAIL
Identity — theoretical monoisotopic masscalculated from molecular formula4111.0524Da—NOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)4111.0360Da—NOT TESTED
Mass accuracyobserved vs theoretical-4.0ppm± 15PASS
Total peptide contentby difference from the gravimetric mass balance83.71%w/w—NOT TESTED
Target-compound contenttotal peptide content × purity81.91%w/w—NOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen12.73mg10 mg declaredNOT TESTED
Recovered target peptidegross fill × target content10.427mg10 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim104.3%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate5.54%≤ 8.0PASS
Counter-ion (TFA)anion-exchange ion chromatography9.92%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.83%—NOT TESTED
Endotoxinkinetic chromogenic LAL0.38EU/mg≤ 5.0PASS
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 procedureClear, colourless, no visible particulates—clear, no visible particulatesPASS
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration3.56—2.5 – 8.0PASS
Retention time (observed)RP-HPLC, 30 min gradient18.56min18.42 ± 0.45 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.08—0.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²39,480—≥ 20,000PASS
Resolution to nearest impurityvs deamidated (Asn→Asp, +1 Da)1.33—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.

01166233234984664 Semaglutide18.56 min · 97.85 % 18.0519.9222.27 same trace · ×20 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 39,480, and skew follows the reported asymmetry factor of 1.08. 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 1.52 % impurity against a 97.85 % main peak is a line two pixels tall; the main peak runs off-scale there by design.
#PeakRTArea (µV·s)% areaΔ mass (Da)
1Semaglutide — main peak18.564,755,81397.85—
2deamidated (Asn→Asp, +1 Da)18.0573,8771.52+0.984
3C18 diacid mono-ester19.9220,4130.42+14.016
4des-AEEA semaglutide (−145 Da)17.744,8600.10-145.074
5semaglutide dimer22.273,4020.07+4111.052
6Met(O) sulfoxide (+16 Da)17.889720.02+15.995
7des-His1 truncate (−137 Da)17.429720.02-137.059
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 4111.0524 Da, computed from C187H291N45O59. All ppm figures on this site are against monoisotopic values — see why that matters.

02550751005008001100140017002000 [M+4H]4+1028.77[M+3H]3+1371.35[M+5H]5+823.21 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 4111.0360 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+686.1827686.1799-0.00288.4
5+823.2178823.2145-0.003353.4
4+1028.77041028.7663-0.0041100.0
3+1371.35811371.3526-0.005556.2
2+2056.53352056.5253-0.00828.7
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.

ComponentDetermination%w/w of cake
WaterKarl Fischer5.54
Counter-ion (TFA)ion chromatography9.92
Residual solvent + inorganic residueestimated0.83
Total peptide contentby difference83.71
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)98.0897.85divergence +0.23 pp vs batch median
Total impurities (% area)1.922.15
Largest single impurity (% area)1.051.52
Water (%)not stated5.54
Counter-ion (%)7.99.92
Peptide content (%w/w)88.083.71
Endotoxin (EU/mg)not stated0.38
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 (ambient, 16 d) → laboratory (courier, cold pack, 9 d) → assay.
Assay date
05 Sep 2025
Submitted to the index
14 Sep 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.

quad_unit
Instrument class is on the record, which is what allows -4.0 ppm to be read at its proper weight. The index distinguishes "confirmed" from "consistent with" precisely on this field.
aeea_linker
Side-chain-modified compounds lose their linker readily in source, and a clean parent mass at -4.0 ppm indicates the ionisation conditions were gentle enough not to.
Section 7

Related records

Same batch — lot HOMO-2506-M5731 n=15

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2025-019835HOMO-2506-M5731Janoshik2025-Q397.605.6892.0Buyer-sourced1MARGINAL
AX-2025-019836HOMO-2506-M5731Janoshik2025-Q398.066.2589.0Buyer-sourced2MARGINAL
AX-2025-019837HOMO-2506-M5731Medutest2025-Q397.985.88—Buyer-sourced1MARGINAL
AX-2025-019838HOMO-2506-M5731Janoshik2025-Q397.246.3795.9Buyer-sourced1MARGINAL
AX-2025-019839HOMO-2506-M5731Janoshik2025-Q398.106.4595.7Buyer-sourced1MARGINAL
AX-2025-019840HOMO-2506-M5731PeptideMeter2025-Q397.515.9188.7Buyer-sourced2MARGINAL
AX-2025-019841HOMO-2506-M5731Janoshik2025-Q397.936.0291.4Buyer-sourced1MARGINAL
AX-2025-019842HOMO-2506-M5731Janoshik2025-Q397.606.12—Buyer-sourced1MARGINAL
AX-2025-019844HOMO-2506-M5731PeptideMeter2025-Q398.026.1991.2Buyer-sourced2FAIL
AX-2025-019845HOMO-2506-M5731Janoshik2025-Q397.366.2494.1Buyer-sourced1MARGINAL
AX-2025-019846HOMO-2506-M5731Nordanalyt2025-Q397.486.2389.5Buyer-sourced2MARGINAL
AX-2025-019847HOMO-2506-M5731VendorInvestigate2025-Q397.366.04—Buyer-sourced1MARGINAL
AX-2025-019848HOMO-2506-M5731PeptideMeter2025-Q397.965.88—Buyer-sourced1MARGINAL
AX-2025-019849HOMO-2506-M5731Janoshik2025-Q398.016.54—Buyer-sourced1MARGINAL

Cross-sections

Other recent Semaglutide records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043376WXTWXT-2604-C3248Janoshik2026-Q397.084.22—Buyer-sourced1MARGINAL
AX-2026-042424HomopeptideHOMO-2604-X3806PeptideMeter2026-Q398.854.8792.0Buyer-sourced0PASS
AX-2026-041643FGPFGP-2602-M8547Janoshik2026-Q399.312.79100.7Buyer-sourced0PASS
AX-2026-041334WWBWWB-2606-N3192Janoshik2026-Q398.934.6299.9Buyer-sourced0PASS
AX-2026-042002AMBAMB-2607-N6274VendorInvestigate2026-Q398.236.3797.1Buyer-sourced1MARGINAL
AX-2026-041337WWBWWB-2606-N3192Nordanalyt2026-Q399.523.92—Buyer-sourced0PASS
AX-2026-042595HJHJ-2608-C7002Janoshik2026-Q399.503.55—Buyer-sourced1MARGINAL
AX-2026-042217TFCTFC-2604-X9037PeptideMeter2026-Q398.954.6196.9Buyer-sourced0PASS
Other recent Homopeptide records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042437RetatrutideHOMO-2605-V4718Nordanalyt2026-Q398.683.67102.8Buyer-sourced0PASS
AX-2026-042424SemaglutideHOMO-2604-X3806PeptideMeter2026-Q398.854.8792.0Buyer-sourced0PASS
AX-2026-042503IGF-1 LR3HOMO-2607-P5131Janoshik2026-Q399.365.99—Buyer-sourced0PASS
AX-2026-042492SS-31 (Elamipretide)HOMO-2604-D5484Medutest2026-Q399.932.40—Buyer-sourced0PASS
AX-2026-042491SS-31 (Elamipretide)HOMO-2604-D5484Kestrel2026-Q399.933.24—Supplier-supplied0PASS
AX-2026-042473LL-37HOMO-2602-G5165Janoshik2026-Q399.015.00—Buyer-sourced0PASS
AX-2026-042441RetatrutideHOMO-2605-V4718Medutest2026-Q398.934.22—Buyer-sourced0PASS
AX-2026-042474LL-37HOMO-2602-G5165Janoshik2026-Q399.185.44—Buyer-sourced0PASS