AssayIndex

AX-2026-042284

Semaglutide · 2 mg declared · Hunan Aslsen Technology Co., Ltd. · lot HOMO-2604-M2254

MARGINALPURITY ONLY
Report ID
AX-2026-042284
Compound
Semaglutide
Compound class
Incretin analogues and co-agonists
Supplier
Homopeptide — Hunan Aslsen Technology Co., Ltd.
Batch / lot
HOMO-2604-M2254
Declared label claim
2mg
Laboratory
Janoshik Analytical
Assay date
21 Apr 2026
Submitted
09 May 2026
Quarter
2026-Q2
Submitter
lal_assay
Sample provenance
Supplier-supplied
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 nm99.51% area≥ 97.0PASS
Total impuritiesRP-HPLC, sum of reported peaks0.49% area≤ 3.0PASS
Largest single impurityRP-HPLC — [D-Aib8]-diastereomer0.27% area≤ 1.00PASS
Identitynot ordered on this submissionnot determinedrequired for VERIFIED statusNOT TESTED
Peptide contentnot ordered on this submissionnot determinedrequired to check label claimNOT TESTED
Water contentKarl Fischer, coulometric, duplicate2.48%≤ 8.0PASS
Counter-ion (TFA)anion-exchange ion chromatography8.28%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.99%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 backgroundWhite 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 calibration2.402.5 – 8.0FAIL
Retention time (observed)RP-HPLC, 30 min gradient18.66min18.42 ± 0.45 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.160.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²45,692≥ 20,000PASS
Resolution to nearest impurityvs [D-Aib8]-diastereomer0.67no 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.

01222244436664888 Semaglutide18.66 min · 99.51 % 18.4220.71 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, 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 45,692, and skew follows the reported asymmetry factor of 1.16. 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 0.27 % impurity against a 99.51 % 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 peak18.664,836,49499.51
2[D-Aib8]-diastereomer18.4213,1230.270.000
3deamidated (Asn→Asp, +1 Da)18.154,8600.10+0.984
4tBu-protected residual (+56 Da)20.713,4020.07+56.063
5des-AEEA semaglutide (−145 Da)17.842,4300.05-145.074
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 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)99.3399.51divergence +0.38 pp vs batch median
Total impurities (% area)0.670.49
Largest single impurity (% area)0.370.27
Water (%)0.92.48
Counter-ion (%)not stated8.28
Peptide content (%w/w)not statednot determined
Endotoxin (EU/mg)not statednot 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
Supplier-supplied
Evidentiary weight
Weaker evidence. Read with the caveat below.
Chain of custody
Supplier despatch → laboratory direct (courier, cold pack, 12 d) → assay. Submitter did not handle the vial.
Assay date
21 Apr 2026
Submitted to the index
09 May 2026
Laboratory
Janoshik Analytical, Ostrava, Czechia
Method basis
30 min gradient · high-resolution MS
Verification status
PURITY ONLY
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-2604-M2254 n=5

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042282HOMO-2604-M2254Janoshik2026-Q299.052.86Supplier-supplied2MARGINAL
AX-2026-042283HOMO-2604-M2254Janoshik2026-Q298.502.58Laboratory-retained1MARGINAL
AX-2026-042285HOMO-2604-M2254VendorInvestigate2026-Q298.172.79105.1Buyer-sourced1MARGINAL
AX-2026-042286HOMO-2604-M2254Medutest2026-Q298.952.40Supplier-supplied2MARGINAL
Other recent Semaglutide records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041334WWBWWB-2606-N3192Janoshik2026-Q398.835.04Supplier-supplied1MARGINAL
AX-2026-041932TFCTFC-2604-X4301Janoshik2026-Q398.884.31Supplier-supplied0PASS
AX-2026-042347HJHJ-2608-C3931VendorInvestigate2026-Q398.803.41100.2Buyer-sourced1MARGINAL
AX-2026-041886JEEPJEEP-2607-X3911Nordanalyt2026-Q399.194.0396.4Supplier-supplied2MARGINAL
AX-2026-041337WWBWWB-2606-N3192Nordanalyt2026-Q398.964.81Supplier-supplied1MARGINAL
AX-2026-042172HomopeptideHOMO-2604-X8921Janoshik2026-Q399.645.1691.9Supplier-supplied1MARGINAL
AX-2026-041767FGPFGP-2602-M1508PeptideMeter2026-Q398.652.54Supplier-supplied2FAIL
AX-2026-041882JEEPJEEP-2607-X3911Nordanalyt2026-Q399.174.52Supplier-supplied1MARGINAL
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