AssayIndex

AX-2025-020531

Semaglutide · 2 mg declared · Shanghai Sigma-Audley New Material Technology Co., Ltd. · lot SSA-2502-U6907

MARGINALVERIFIED
Report ID
AX-2025-020531
Compound
Semaglutide
Compound class
Incretin analogues and co-agonists
Supplier
SSA — Shanghai Sigma-Audley New Material Technology Co., Ltd.
Batch / lot
SSA-2502-U6907
Declared label claim
2mg
Laboratory
PeptideMeter
Assay date
29 Aug 2025
Submitted
15 Sep 2025
Quarter
2025-Q3
Submitter
Contributor #E-6741
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 nm98.02% area≥ 97.0PASS
Total impuritiesRP-HPLC, sum of reported peaks1.98% area≤ 3.0PASS
Largest single impurityRP-HPLC — [D-Aib8]-diastereomer1.23% area≤ 1.00FAIL
Identity — theoretical monoisotopic masscalculated from molecular formula4111.0524Da—NOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)4111.0545Da—NOT TESTED
Mass accuracyobserved vs theoretical+0.5ppm± 15PASS
Total peptide contentby difference from the gravimetric mass balance83.19%w/w—NOT TESTED
Target-compound contenttotal peptide content × purity81.54%w/w—NOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen2.20mg2 mg declaredNOT TESTED
Recovered target peptidegross fill × target content1.794mg2 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim89.7%90.0 – 110.0FAIL
Water contentKarl Fischer, coulometric, duplicate5.91%≤ 8.0PASS
Counter-ion (TFA)anion-exchange ion chromatography10.49%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.41%—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 cake, partially collapsed—white to off-white intact cakeFAIL
Reconstitution clarityreconstituted per submitter procedureClear, colourless, no visible particulates—clear, no visible particulatesPASS
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration4.08—2.5 – 8.0PASS
Retention time (observed)RP-HPLC, 28 min gradient17.21min17.29 ± 0.45 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.11—0.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²46,286—≥ 20,000PASS
Resolution to nearest impurityvs [D-Aib8]-diastereomer0.68—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.

01345269040355380 Semaglutide17.21 min · 98.02 % 16.99 same trace · ×50 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 46,286, and skew follows the reported asymmetry factor of 1.11. 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 1.23 % impurity against a 98.02 % 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 peak17.214,764,07698.02—
2[D-Aib8]-diastereomer16.9959,7821.230.000
3des-His1 truncate (−137 Da)16.1517,9830.37-137.059
4C18 diacid mono-ester18.488,7490.18+14.016
5deamidated (Asn→Asp, +1 Da)16.734,8600.10+0.984
6Met(O) sulfoxide (+16 Da)16.582,4300.05+15.995
7des-AEEA semaglutide (−145 Da)16.442,4300.05-145.074
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 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 4111.0545 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+686.1827686.18300.00038.0
5+823.2178823.21820.000457.6
4+1028.77041028.77090.0005100.0
3+1371.35811371.35880.000752.2
2+2056.53352056.53450.00108.2
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 Fischer5.91
Counter-ion (TFA)ion chromatography10.49
Residual solvent + inorganic residueestimated0.41
Total peptide contentby difference83.19
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)98.3798.02divergence +0.38 pp vs batch median
Total impurities (% area)1.631.98
Largest single impurity (% area)not stated1.23
Water (%)not stated5.91
Counter-ion (%)3.310.49
Peptide content (%w/w)92.683.19
Endotoxin (EU/mg)not statednot 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 (ambient, 16 d) → laboratory (courier, cold pack, 12 d) → assay.
Assay date
29 Aug 2025
Submitted to the index
15 Sep 2025
Laboratory
PeptideMeter, Tallinn, Estonia
Method basis
28 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
+0.5 ppm at this mass is a clean identity confirmation. With retention at 17.21 min, Semaglutide is established as the species measured. Note what it does not exclude: a mass-identical diastereomer, which no mass measurement of any resolution can.
tfa_counter
Ion chromatography is the reference method for this and it is fast. Where a certificate states a counter-ion identity but no content, the missing number is usually one run away.
Section 7

Related records

Same batch — lot SSA-2502-U6907 n=12

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2025-020524SSA-2502-U6907Medutest2025-Q397.605.63—Buyer-sourced0PASS
AX-2025-020525SSA-2502-U6907Kestrel2025-Q398.105.1298.8Buyer-sourced0PASS
AX-2025-020526SSA-2502-U6907PeptideMeter2025-Q398.095.40102.2Buyer-sourced0PASS
AX-2025-020527SSA-2502-U6907VendorInvestigate2025-Q397.745.29102.4Buyer-sourced0PASS
AX-2025-020528SSA-2502-U6907Janoshik2025-Q397.875.38—Buyer-sourced0PASS
AX-2025-020529SSA-2502-U6907Medutest2025-Q398.165.98105.7Buyer-sourced0PASS
AX-2025-020530SSA-2502-U6907Janoshik2025-Q398.175.4091.1Buyer-sourced0PASS
AX-2025-020532SSA-2502-U6907VendorInvestigate2025-Q397.965.08—Buyer-sourced0PASS
AX-2025-020533SSA-2502-U6907Medutest2025-Q398.025.40104.0Buyer-sourced0PASS
AX-2025-020534SSA-2502-U6907Janoshik2025-Q397.885.65103.3Buyer-sourced0PASS
AX-2025-020535SSA-2502-U6907Janoshik2025-Q397.645.41—Buyer-sourced0PASS

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 SSA records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043135BPC-157SSA-2601-N6863Nordanalyt2026-Q298.164.6692.8Buyer-sourced1MARGINAL
AX-2026-043160GHK-CuSSA-2604-V7731Janoshik2026-Q298.014.0291.8Buyer-sourced0PASS
AX-2026-043157GHK-CuSSA-2604-V7731Medutest2026-Q299.195.14—Supplier-supplied0PASS
AX-2026-043141BPC-157SSA-2601-N6863Janoshik2026-Q298.064.0694.6Buyer-sourced1MARGINAL
AX-2026-043154GHK-CuSSA-2604-V7731PeptideMeter2026-Q297.824.82101.6Buyer-sourced0PASS
AX-2026-043137BPC-157SSA-2601-N6863PeptideMeter2026-Q298.174.14—Buyer-sourced1MARGINAL
AX-2026-043162GHK-CuSSA-2604-V7731Janoshik2026-Q298.504.36—Supplier-supplied0PASS
AX-2026-043134BPC-157SSA-2601-N6863Medutest2026-Q297.894.01—Buyer-sourced1FAIL