AssayIndex

AX-2026-043118

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

MARGINALPURITY ONLY
Report ID
AX-2026-043118
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
Medutest
Assay date
23 Jun 2026
Submitted
02 Jul 2026
Quarter
2026-Q2
Submitter
m.cabrera
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, 25 min gradient, 214 nm98.29% area≥ 96.5PASS
Total impuritiesRP-HPLC, sum of reported peaks1.71% area≤ 3.5PASS
Largest single impurityRP-HPLC — trifluoroacetyl adduct (+96 Da)0.96% area≤ 1.00PASS
Identitynot ordered on this submissionnot determinedrequired for VERIFIED statusNOT TESTED
Total peptide contentby difference from the gravimetric mass balance87.42%w/wNOT TESTED
Target-compound contenttotal peptide content × purity85.93%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen9.29mg9 mg declaredNOT TESTED
Recovered target peptidegross fill × target content7.983mg9 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim88.7%90.0 – 110.0FAIL
Water contentKarl Fischer, coulometric, duplicate2.65%≤ 8.0PASS
Counter-ion (TFA)anion-exchange ion chromatography9.67%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.26%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 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 calibration3.642.5 – 8.0PASS
Retention time (observed)RP-HPLC, 25 min gradient16.55min16.44 ± 0.50 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.490.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²33,797≥ 20,000PASS
Resolution to nearest impurityvs [D-Aib2]-diastereomer0.47no 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.

01017203430514068 Mazdutide16.55 min · 98.29 % 17.3015.10 same trace · ×50 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 0481216202428 Retention time (min) Response (mAU)
Figure 1. RP-HPLC trace, 25 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 33,797, and skew follows the reported asymmetry factor of 1.49. 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 0.96 % impurity against a 98.29 % 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 peak16.554,777,19998.29
2trifluoroacetyl adduct (+96 Da)17.3046,6590.96+95.982
3[D-Aib2]-diastereomer16.3819,9270.410.000
4oxidised Met (+16 Da)15.9711,1790.23+15.995
5truncated (4-39)15.102,9160.06-315.169
6des-Aib2 analogue16.232,4300.05-85.053
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 Fischer2.65
Counter-ion (TFA)ion chromatography9.67
Residual solvent + inorganic residueestimated0.26
Total peptide contentby difference87.42
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)99.4198.29divergence +0.67 pp vs batch median
Total impurities (% area)0.591.71
Largest single impurity (% area)not stated0.96
Water (%)2.22.65
Counter-ion (%)not stated9.67
Peptide content (%w/w)not stated87.42
Endotoxin (EU/mg)not statednot determined
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 → third-party forwarder (15 d) → laboratory (courier, cold pack, 10 d) → assay.
Assay date
23 Jun 2026
Submitted to the index
02 Jul 2026
Laboratory
Medutest, Ljubljana, Slovenia
Method basis
25 min gradient · unit-resolution MS
Verification status
PURITY ONLY
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-2026-043115SSA-2605-G6781PeptideMeter2026-Q298.452.4897.0Buyer-sourced1MARGINAL
AX-2026-043116SSA-2605-G6781Janoshik2026-Q298.652.63104.6Laboratory-retained1MARGINAL
AX-2026-043117SSA-2605-G6781Janoshik2026-Q299.233.6790.4Supplier-supplied1MARGINAL
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-2026-042562ERPERP-2603-D7882Janoshik2026-Q297.464.39102.6Supplier-supplied2MARGINAL
AX-2026-042561ERPERP-2603-D7882PeptideMeter2026-Q297.944.0497.5Supplier-supplied2MARGINAL
AX-2026-043115SSASSA-2605-G6781PeptideMeter2026-Q298.452.4897.0Buyer-sourced1MARGINAL
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-2026-043138BPC-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
AX-2026-043142SemaxSSA-2604-L7628VendorInvestigate2026-Q298.308.24Buyer-sourced2FAIL