AssayIndex

AX-2026-042646

Semaglutide · 2 mg declared · Shanghai Wibson Biotechnology Co., Ltd. · lot SWB-2512-L7774

MARGINALPURITY ONLY
Report ID
AX-2026-042646
Compound
Semaglutide
Compound class
Incretin analogues and co-agonists
Supplier
SWB — Shanghai Wibson Biotechnology Co., Ltd.
Batch / lot
SWB-2512-L7774
Declared label claim
2mg
Laboratory
PeptideMeter
Assay date
11 Feb 2026
Submitted
16 Feb 2026
Quarter
2026-Q1
Submitter
r.ferrari
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, 28 min gradient, 214 nm97.93% area≥ 97.0PASS
Total impuritiesRP-HPLC, sum of reported peaks2.07% area≤ 3.0PASS
Largest single impurityRP-HPLC — [D-Aib8]-diastereomer1.43% area≤ 1.00FAIL
Identitynot ordered on this submissionnot determinedrequired for VERIFIED statusNOT TESTED
Total peptide contentby difference from the gravimetric mass balance86.60%w/wNOT TESTED
Target-compound contenttotal peptide content × purity84.81%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen2.17mg2 mg declaredNOT TESTED
Recovered target peptidegross fill × target content1.840mg2 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim92.0%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate5.14%≤ 8.0PASS
Counter-ion (TFA)anion-exchange ion chromatography7.25%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/1.01%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 cake, partial shrinkage from vial wallwhite to off-white intact cakeFAIL
Reconstitution clarityreconstituted per submitter procedureClear with a single visible fibreclear, no visible particulatesFAIL
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration4.872.5 – 8.0PASS
Retention time (observed)RP-HPLC, 28 min gradient17.37min17.29 ± 0.45 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.100.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²74,216≥ 20,000PASS
Resolution to nearest impurityvs [D-Aib8]-diastereomer0.86no 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.

01693338750806774 Semaglutide17.37 min · 97.93 % 17.1519.28 same trace · ×20 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 051015202530 Retention time (min) Response (mAU)
Figure 1. RP-HPLC trace, 28 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 74,216, and skew follows the reported asymmetry factor of 1.10. 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 1.43 % impurity against a 97.93 % 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 peak17.374,759,70297.93
2[D-Aib8]-diastereomer17.1569,5021.430.000
3C18 diacid mono-ester18.6415,5530.32+14.016
4tBu-protected residual (+56 Da)19.289,2350.19+56.063
5Met(O) sulfoxide (+16 Da)16.742,9160.06+15.995
6des-AEEA semaglutide (−145 Da)16.602,4300.05-145.074
7semaglutide dimer20.839720.02+4111.052
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.

ComponentDetermination%w/w of cake
WaterKarl Fischer5.14
Counter-ion (TFA)ion chromatography7.25
Residual solvent + inorganic residueestimated1.01
Total peptide contentby difference86.60
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)98.2297.93divergence +0.29 pp vs batch median
Total impurities (% area)0.952.07
Largest single impurity (% area)1.781.43
Water (%)not stated5.14
Counter-ion (%)not stated7.25
Peptide content (%w/w)91.786.60
Endotoxin (EU/mg)not statednot determined
Method stated on certificateNOno 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 → third-party forwarder (26 d) → laboratory (courier, cold pack, 3 d) → assay.
Assay date
11 Feb 2026
Submitted to the index
16 Feb 2026
Laboratory
PeptideMeter, Tallinn, Estonia
Method basis
28 min gradient · high-resolution MS
Verification status
PURITY ONLY
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.

sample_vs_retail
A retail vial at 97.93 % is worth more evidentially than a selected vial at a higher figure. That is the whole argument for recording provenance at all.
lot_traceability
Lot SWB-2512-L7774 on the vial matches the certificate that came with it. That is the check every buyer can do in ten seconds and most do not.
dedupe_logic
Two retail purchases of the same lot from different buyers are genuinely independent. Two aliquots of one purchase are not, and the index does not treat them as such.
Section 7

Related records

Same batch — lot SWB-2512-L7774 n=1

This is the only report on this lot. One report is not a batch characterisation.

Other recent Semaglutide records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043376WXTWXT-2604-C3248Janoshik2026-Q397.084.22Buyer-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-Q399.523.92Buyer-sourced0PASS
AX-2026-042595HJHJ-2608-C7002Janoshik2026-Q399.503.55Buyer-sourced1MARGINAL
AX-2026-042217TFCTFC-2604-X9037PeptideMeter2026-Q398.954.6196.9Buyer-sourced0PASS
Other recent SWB records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042637SemaglutideSWB-2602-X7905Janoshik2026-Q398.374.26102.9Buyer-sourced0PASS
AX-2026-042645SemaglutideSWB-2602-X7905Medutest2026-Q398.484.5295.2Buyer-sourced0PASS
AX-2026-042642SemaglutideSWB-2602-X7905PeptideMeter2026-Q397.964.4890.8Buyer-sourced0PASS
AX-2026-042640SemaglutideSWB-2602-X7905PeptideMeter2026-Q398.554.29Buyer-sourced0PASS
AX-2026-042638SemaglutideSWB-2602-X7905Janoshik2026-Q398.743.65Buyer-sourced0PASS
AX-2026-042639SemaglutideSWB-2602-X7905Janoshik2026-Q398.774.21Supplier-supplied0PASS
AX-2026-042641SemaglutideSWB-2602-X7905Janoshik2026-Q398.864.4899.1Buyer-sourced0PASS
AX-2026-042644SemaglutideSWB-2602-X7905PeptideMeter2026-Q398.763.5797.7Buyer-sourced0PASS