AssayIndex

AX-2026-043115

Mazdutide · 9 mg declared · Shanghai Sigma-Audley New Material Technology Co., Ltd. · lot SSA-2605-G6781

MARGINALVERIFIED
Report ID
AX-2026-043115
Compound
Mazdutide
Compound class
Incretin analogues and co-agonists
Supplier
SSA — Shanghai Sigma-Audley New Material Technology Co., Ltd.
Batch / lot
SSA-2605-G6781
Declared label claim
9mg
Laboratory
PeptideMeter
Assay date
20 May 2026
Submitted
14 Jun 2026
Quarter
2026-Q2
Submitter
a.kuusela
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 nm98.45% area≥ 96.5PASS
Total impuritiesRP-HPLC, sum of reported peaks1.55% area≤ 3.5PASS
Largest single impurityRP-HPLC — des-Aib2 analogue0.74% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula4912.6408DaNOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)4912.6354DaNOT TESTED
Mass accuracyobserved vs theoretical-1.1ppm± 15PASS
Total peptide contentby difference from the gravimetric mass balance90.92%w/wNOT TESTED
Target-compound contenttotal peptide content × purity89.51%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen9.75mg9 mg declaredNOT TESTED
Recovered target peptidegross fill × target content8.727mg9 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim97.0%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate2.48%≤ 8.0PASS
Counter-ion (TFA)anion-exchange ion chromatography5.76%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.84%NOT TESTED
Endotoxinkinetic chromogenic LAL0.67EU/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 calibration3.702.5 – 8.0PASS
Retention time (observed)RP-HPLC, 28 min gradient18.26min18.23 ± 0.50 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.120.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²60,977≥ 20,000PASS
Resolution to nearest impurityvs [D-Aib2]-diastereomer0.65no 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.

01454290843625816 Mazdutide18.26 min · 98.45 % 17.90 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 60,977, 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 0.74 % impurity against a 98.45 % main peak is a line two pixels tall; the main peak runs off-scale there by design.
#PeakRTArea (µV·s)% areaΔ mass (Da)
1Mazdutide — main peak18.264,784,97598.45
2des-Aib2 analogue17.9035,9660.74-85.053
3oxidised Met (+16 Da)17.6123,8160.49+15.995
4[D-Aib2]-diastereomer18.068,2630.170.000
5truncated (4-39)16.644,3740.09-315.169
6trifluoroacetyl adduct (+96 Da)19.102,9160.06+95.982
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 4912.6408 Da, computed from C226H352N50O70. All ppm figures on this site are against monoisotopic values — see why that matters.

02550751005757759751175137515751775 [M+5H]5+983.53[M+6H]6+819.78[M+4H]4+1229.17 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 4912.6354 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 (%)
7+702.8131702.8123-0.00088.1
6+819.7807819.7798-0.000957.0
5+983.5354983.5344-0.0010100.0
4+1229.16751229.1661-0.001454.1
3+1638.55421638.5524-0.00188.3
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 Fischer2.48
Counter-ion (TFA)ion chromatography5.76
Residual solvent + inorganic residueestimated0.84
Total peptide contentby difference90.92
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)99.4198.45divergence +0.67 pp vs batch median
Total impurities (% area)0.591.55
Largest single impurity (% area)not stated0.74
Water (%)2.22.48
Counter-ion (%)not stated5.76
Peptide content (%w/w)not stated90.92
Endotoxin (EU/mg)not stated0.67
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
Buyer-sourced
Evidentiary weight
Strongest available evidence in this index.
Chain of custody
Retail purchase → submitter (ambient, 24 d) → laboratory (hand-carried, 10 d) → assay.
Assay date
20 May 2026
Submitted to the index
14 Jun 2026
Laboratory
PeptideMeter, Tallinn, Estonia
Method basis
28 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 SSA-2605-G6781 n=9

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043113SSA-2605-G6781Janoshik2026-Q298.492.68Supplier-supplied1MARGINAL
AX-2026-043114SSA-2605-G6781Janoshik2026-Q299.023.41101.2Supplier-supplied1MARGINAL
AX-2026-043116SSA-2605-G6781Janoshik2026-Q298.652.63104.6Laboratory-retained1MARGINAL
AX-2026-043117SSA-2605-G6781Janoshik2026-Q299.233.6790.4Supplier-supplied1MARGINAL
AX-2026-043118SSA-2605-G6781Medutest2026-Q298.292.6588.7Buyer-sourced2MARGINAL
AX-2026-043119SSA-2605-G6781Janoshik2026-Q299.282.75Supplier-supplied1MARGINAL
AX-2026-043120SSA-2605-G6781PeptideMeter2026-Q298.743.24104.0Supplier-supplied1MARGINAL
AX-2026-043121SSA-2605-G6781Medutest2026-Q298.792.52Supplier-supplied1MARGINAL
Other recent Mazdutide records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042560ERPERP-2603-D7882VendorInvestigate2026-Q297.283.81104.1Buyer-sourced2MARGINAL
AX-2026-043117SSASSA-2605-G6781Janoshik2026-Q299.233.6790.4Supplier-supplied1MARGINAL
AX-2026-043118SSASSA-2605-G6781Medutest2026-Q298.292.6588.7Buyer-sourced2MARGINAL
AX-2026-042562ERPERP-2603-D7882Janoshik2026-Q297.464.39102.6Supplier-supplied2MARGINAL
AX-2026-042561ERPERP-2603-D7882PeptideMeter2026-Q297.944.0497.5Supplier-supplied2MARGINAL
AX-2026-043119SSASSA-2605-G6781Janoshik2026-Q299.282.75Supplier-supplied1MARGINAL
AX-2026-043120SSASSA-2605-G6781PeptideMeter2026-Q298.743.24104.0Supplier-supplied1MARGINAL
AX-2026-043116SSASSA-2605-G6781Janoshik2026-Q298.652.63104.6Laboratory-retained1MARGINAL
Other recent SSA records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043144GHK-CuSSA-2604-V7620Janoshik2026-Q298.355.25105.8Supplier-supplied0PASS
AX-2026-043141SemaxSSA-2604-L7628Kestrel2026-Q298.848.5893.2Supplier-supplied2MARGINAL
AX-2026-043117MazdutideSSA-2605-G6781Janoshik2026-Q299.233.6790.4Supplier-supplied1MARGINAL
AX-2026-043136BPC-157SSA-2601-N6752Janoshik2026-Q297.754.32Supplier-supplied2FAIL
AX-2026-043118MazdutideSSA-2605-G6781Medutest2026-Q298.292.6588.7Buyer-sourced2MARGINAL
AX-2026-043138BPC-157SSA-2601-N6752Janoshik2026-Q298.004.30101.0Supplier-supplied1MARGINAL
AX-2026-043137BPC-157SSA-2601-N6752Janoshik2026-Q297.414.36104.5Laboratory-retained1FAIL
AX-2026-043146Enclomiphene citrateSSA-2603-C6950Medutest2026-Q297.923.1192.9Buyer-sourced2FAIL