AssayIndex

AX-2026-041577

Semaglutide · 5 mg declared · Qingdao Sigma Chemical Co., Ltd. · lot QSC-2602-L7350

PASSVERIFIED
Report ID
AX-2026-041577
Compound
Semaglutide
Compound class
Incretin analogues and co-agonists
Supplier
QSC — Qingdao Sigma Chemical Co., Ltd.
Batch / lot
QSC-2602-L7350
Declared label claim
5mg
Laboratory
Nordanalyt Laboratories
Assay date
26 Feb 2026
Submitted
20 Mar 2026
Quarter
2026-Q1
Submitter
a.castellanos
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, 35 min gradient, 214 nm99.76% area≥ 97.0PASS
Total impuritiesRP-HPLC, sum of reported peaks0.24% area≤ 3.0PASS
Largest single impurityRP-HPLC — deamidated (Asn→Asp, +1 Da)0.16% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula4111.0524DaNOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)4111.0487DaNOT TESTED
Mass accuracyobserved vs theoretical-0.9ppm± 15PASS
Total peptide contentby difference from the gravimetric mass balance86.35%w/wNOT TESTED
Target-compound contenttotal peptide content × purity86.14%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen6.12mg5 mg declaredNOT TESTED
Recovered target peptidegross fill × target content5.272mg5 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim105.4%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate3.79%≤ 8.0PASS
Counter-ion (TFA)anion-exchange ion chromatography9.01%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.85%NOT TESTED
Endotoxinkinetic chromogenic LAL0.84EU/mg≤ 5.0PASS
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 calibration3.092.5 – 8.0PASS
Retention time (observed)RP-HPLC, 35 min gradient21.23min21.24 ± 0.45 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.070.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²69,764≥ 20,000PASS
Resolution to nearest impurityvs deamidated (Asn→Asp, +1 Da)1.81no 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.

01388277641645552 Semaglutide21.23 min · 99.76 % 20.64 same trace · ×200 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 0510152025303540 Retention time (min) Response (mAU)
Figure 1. RP-HPLC trace, 35 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 69,764, and skew follows the reported asymmetry factor of 1.07. 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 0.16 % impurity against a 99.76 % 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 peak21.234,848,64599.76
2deamidated (Asn→Asp, +1 Da)20.647,7760.16+0.984
3des-His1 truncate (−137 Da)19.902,4300.05-137.059
4des-AEEA semaglutide (−145 Da)20.271,4580.03-145.074
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 4111.0487 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+686.1827686.1821-0.00067.9
5+823.2178823.2170-0.000857.7
4+1028.77041028.7695-0.0009100.0
3+1371.35811371.3568-0.001353.8
2+2056.53352056.5316-0.00198.0
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 Fischer3.79
Counter-ion (TFA)ion chromatography9.01
Residual solvent + inorganic residueestimated0.85
Total peptide contentby difference86.35
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)99.6799.76divergence -0.26 pp vs batch median
Total impurities (% area)0.330.24
Largest single impurity (% area)not stated0.16
Water (%)2.53.79
Counter-ion (%)5.19.01
Peptide content (%w/w)91.886.35
Endotoxin (EU/mg)0.570.84
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 → submitter (ambient, 13 d) → laboratory (hand-carried, 10 d) → assay.
Assay date
26 Feb 2026
Submitted to the index
20 Mar 2026
Laboratory
Nordanalyt Laboratories, Uppsala, Sweden
Method basis
35 min gradient · high-resolution MS
Verification status
VERIFIED
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.

plate_count
99.76 % is normalised area, so it is silent on how much peptide is in the vial. Content and water are the numbers that answer that, and both are on this record. Purity is the good news; content is the actionable news.
des_gly
At 99.76 % the deletion-sequence family is at or below the reporting threshold. On a sequence with a hindered coupling that is a statement about coupling efficiency, and a good one.
aspartimide
Aspartimide formation at an Asp-Gly or Asp-Ser motif shows up as a pair of late-eluting satellites. They are not present above the reporting threshold on this trace.
Section 7

Related records

Same batch — lot QSC-2602-L7350 n=6

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041575QSC-2602-L7350Medutest2026-Q199.934.10Buyer-sourced0PASS
AX-2026-041576QSC-2602-L7350Janoshik2026-Q199.594.1893.5Buyer-sourced0PASS
AX-2026-041578QSC-2602-L7350Janoshik2026-Q199.933.79Buyer-sourced0PASS
AX-2026-041579QSC-2602-L7350Janoshik2026-Q199.934.56Buyer-sourced0PASS
AX-2026-041580QSC-2602-L7350Janoshik2026-Q199.934.28103.3Supplier-supplied0PASS
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 QSC records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041599CJC-1295 (no DAC)QSC-2606-V7416VendorInvestigate2026-Q397.963.52Buyer-sourced1FAIL
AX-2026-041601CJC-1295 (no DAC)QSC-2606-V7416Kestrel2026-Q398.334.10Buyer-sourced1MARGINAL
AX-2026-041602CJC-1295 (no DAC)QSC-2606-V7416VendorInvestigate2026-Q398.363.38101.8Buyer-sourced1MARGINAL
AX-2026-041477TriptorelinQSC-2607-C5749Nordanalyt2026-Q399.533.42Buyer-sourced0PASS
AX-2026-041600CJC-1295 (no DAC)QSC-2606-V7416Nordanalyt2026-Q397.744.91100.9Buyer-sourced1FAIL
AX-2026-041603CJC-1295 (no DAC)QSC-2606-V7416PeptideMeter2026-Q398.434.20Buyer-sourced1MARGINAL
AX-2026-041606CJC-1295 (no DAC)QSC-2606-V7416Janoshik2026-Q398.033.58Buyer-sourced1MARGINAL
AX-2026-041585LiraglutideQSC-2605-W7381Medutest2026-Q399.595.0992.8Laboratory-retained0PASS