AssayIndex

AX-2026-041361

Semaglutide · 10 mg declared · Wuhan Wansheng Biotechnology Co., Ltd. · lot WWB-2508-S3298

MARGINALVERIFIED
Report ID
AX-2026-041361
Compound
Semaglutide
Compound class
Incretin analogues and co-agonists
Supplier
WWB — Wuhan Wansheng Biotechnology Co., Ltd.
Batch / lot
WWB-2508-S3298
Declared label claim
10mg
Laboratory
VendorInvestigate
Assay date
09 Jan 2026
Submitted
11 Jan 2026
Quarter
2026-Q1
Submitter
sample_vs_retail
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 nm98.49% area≥ 97.0PASS
Total impuritiesRP-HPLC, sum of reported peaks1.51% area≤ 3.0PASS
Largest single impurityRP-HPLC — deamidated (Asn→Asp, +1 Da)0.75% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula4111.0524DaNOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)4111.0660DaNOT TESTED
Mass accuracyobserved vs theoretical+3.3ppm± 15PASS
Total peptide contentby difference from the gravimetric mass balance83.33%w/wNOT TESTED
Target-compound contenttotal peptide content × purity82.07%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen11.01mg10 mg declaredNOT TESTED
Recovered target peptidegross fill × target content9.036mg10 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim90.4%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate4.90%≤ 8.0PASS
Counter-ion (TFA)anion-exchange ion chromatography11.34%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.43%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 calibration4.122.5 – 8.0PASS
Retention time (observed)RP-HPLC, 32 min gradient19.60min19.55 ± 0.45 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.120.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²66,393≥ 20,000PASS
Resolution to nearest impurityvs [D-Aib8]-diastereomer0.82no 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.

01414282842425656 Semaglutide19.60 min · 98.49 % 19.0621.0523.56 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, 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 66,393, and skew follows the reported asymmetry factor of 1.12. 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 0.75 % impurity against a 98.49 % 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 peak19.604,786,91998.49
2deamidated (Asn→Asp, +1 Da)19.0636,4520.75+0.984
3[D-Aib8]-diastereomer19.3420,8990.430.000
4des-AEEA semaglutide (−145 Da)18.7310,6930.22-145.074
5Met(O) sulfoxide (+16 Da)18.873,4020.07+15.995
6C18 diacid mono-ester21.059720.02+14.016
7semaglutide dimer23.569720.02+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 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+5H]5+823.22[M+3H]3+1371.36 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 4111.0660 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+686.1827686.18490.00228.5
5+823.2178823.22050.002753.5
4+1028.77041028.77380.0034100.0
3+1371.35811371.36260.004552.8
2+2056.53352056.54030.00687.8
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 Fischer4.90
Counter-ion (TFA)ion chromatography11.34
Residual solvent + inorganic residueestimated0.43
Total peptide contentby difference83.33
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)99.9098.49divergence +0.89 pp vs batch median
Total impurities (% area)not stated1.51
Largest single impurity (% area)not stated0.75
Water (%)3.64.90
Counter-ion (%)not stated11.34
Peptide content (%w/w)not stated83.33
Endotoxin (EU/mg)0.21not 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
Domestic warehouse despatch → submitter (2–8 °C, 24 d) → laboratory (courier, cold pack, 9 d) → assay.
Assay date
09 Jan 2026
Submitted to the index
11 Jan 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 WWB-2508-S3298 n=6

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041356WWB-2508-S3298VendorInvestigate2026-Q199.114.56Buyer-sourced1MARGINAL
AX-2026-041357WWB-2508-S3298Janoshik2026-Q198.904.86103.3Supplier-supplied1MARGINAL
AX-2026-041358WWB-2508-S3298Janoshik2026-Q199.415.01103.4Supplier-supplied1MARGINAL
AX-2026-041359WWB-2508-S3298VendorInvestigate2026-Q198.714.2999.2Buyer-sourced1MARGINAL
AX-2026-041360WWB-2508-S3298PeptideMeter2026-Q199.774.5090.4Supplier-supplied1MARGINAL
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 WWB records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041275LiraglutideWWB-2607-X2189Nordanalyt2026-Q399.615.0397.3Supplier-supplied0PASS
AX-2026-041387BPC-157WWB-2606-H3906Janoshik2026-Q398.954.64Laboratory-retained1MARGINAL
AX-2026-041334SemaglutideWWB-2606-N3192Janoshik2026-Q398.835.04Supplier-supplied1MARGINAL
AX-2026-041337SemaglutideWWB-2606-N3192Nordanalyt2026-Q398.964.81Supplier-supplied1MARGINAL
AX-2026-041385BPC-157WWB-2606-H3906Medutest2026-Q399.314.31Supplier-supplied1MARGINAL
AX-2026-041390BPC-157WWB-2606-H3906Medutest2026-Q399.474.8499.3Supplier-supplied1MARGINAL
AX-2026-041386BPC-157WWB-2606-H3906VendorInvestigate2026-Q399.324.8899.2Buyer-sourced1MARGINAL
AX-2026-041335SemaglutideWWB-2606-N3192Janoshik2026-Q399.554.55100.5Supplier-supplied1MARGINAL