AssayIndex

AX-2026-041918

Mazdutide · 10 mg declared · SinoPep Biotechnology (Changzhou) Co., Ltd. · lot SNP-2602-U4281

MARGINALVERIFIED
Report ID
AX-2026-041918
Compound
Mazdutide
Compound class
Incretin analogues and co-agonists
Supplier
SinoPep — SinoPep Biotechnology (Changzhou) Co., Ltd.
Batch / lot
SNP-2602-U4281
Declared label claim
10mg
Laboratory
Janoshik Analytical
Assay date
05 Apr 2026
Submitted
29 Apr 2026
Quarter
2026-Q2
Submitter
m.vermeulen
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, 30 min gradient, 214 nm97.49% area≥ 96.5PASS
Total impuritiesRP-HPLC, sum of reported peaks2.51% area≤ 3.5PASS
Largest single impurityRP-HPLC — oxidised Met (+16 Da)1.59% area≤ 1.00FAIL
Identity — theoretical monoisotopic masscalculated from molecular formula4912.6408DaNOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)4912.6344DaNOT TESTED
Mass accuracyobserved vs theoretical-1.3ppm± 15PASS
Total peptide contentby difference from the gravimetric mass balance87.84%w/wNOT TESTED
Target-compound contenttotal peptide content × purity85.64%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen11.94mg10 mg declaredNOT TESTED
Recovered target peptidegross fill × target content10.225mg10 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim102.3%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate3.95%≤ 8.0PASS
Counter-ion (TFA)anion-exchange ion chromatography7.79%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.42%NOT TESTED
Endotoxinkinetic chromogenic LAL0.13EU/mg≤ 5.0PASS
Sterilitynot ordered on this submissionnot determinedno growthNOT TESTED
Appearancevisual, diffuse light, black and white backgroundWhite cake, partial shrinkage from vial wallwhite to off-white intact cakeFAIL
Reconstitution clarityreconstituted per submitter procedureClear, colourless, no visible particulatesclear, no visible particulatesPASS
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration2.772.5 – 8.0PASS
Retention time (observed)RP-HPLC, 30 min gradient19.49min19.42 ± 0.50 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.250.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²50,471≥ 20,000PASS
Resolution to nearest impurityvs [D-Aib2]-diastereomer0.59no 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.

01156231334694626 Mazdutide19.49 min · 97.49 % 18.79 same trace · ×20 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 05101520253035 Retention time (min) Response (mAU)
Figure 1. RP-HPLC trace, 30 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 50,471, and skew follows the reported asymmetry factor of 1.25. 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 1.59 % impurity against a 97.49 % 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 peak19.494,738,31697.49
2oxidised Met (+16 Da)18.7977,2791.59+15.995
3des-Aib2 analogue19.1029,6480.61-85.053
4truncated (4-39)17.759,2350.19-315.169
5[D-Aib2]-diastereomer19.282,9160.060.000
6trifluoroacetyl adduct (+96 Da)20.392,9160.06+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 4912.6344 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+702.8131702.8122-0.00098.9
6+819.7807819.7797-0.001053.5
5+983.5354983.5342-0.0012100.0
4+1229.16751229.1659-0.001650.3
3+1638.55421638.5521-0.00218.9
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 Fischer3.95
Counter-ion (TFA)ion chromatography7.79
Residual solvent + inorganic residueestimated0.42
Total peptide contentby difference87.84
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)99.9097.49divergence +1.99 pp vs batch median
Total impurities (% area)0.102.51
Largest single impurity (% area)0.051.59
Water (%)3.83.95
Counter-ion (%)3.37.79
Peptide content (%w/w)92.387.84
Endotoxin (EU/mg)not stated0.13
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, 30 d) → laboratory (courier, cold pack, 12 d) → assay.
Assay date
05 Apr 2026
Submitted to the index
29 Apr 2026
Laboratory
Janoshik Analytical, Ostrava, Czechia
Method basis
30 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.

ppm_error
Well inside class limit. Worth noting that the class limits are set by mass rather than globally, because the same ppm is a different number of daltons at 340 and at 4,800.
buyer_sourced
Independently purchased, at the submitter's own cost, forwarded without the supplier's involvement. That is the definition and this record meets it.
Section 7

Related records

Same batch — lot SNP-2602-U4281 n=8

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041915SNP-2602-U4281PeptideMeter2026-Q297.894.1094.8Buyer-sourced1MARGINAL
AX-2026-041916SNP-2602-U4281Janoshik2026-Q297.923.65Buyer-sourced1MARGINAL
AX-2026-041917SNP-2602-U4281Janoshik2026-Q298.023.9890.6Buyer-sourced1MARGINAL
AX-2026-041919SNP-2602-U4281Nordanalyt2026-Q298.014.3793.8Buyer-sourced1MARGINAL
AX-2026-041920SNP-2602-U4281Janoshik2026-Q297.774.4188.7Buyer-sourced2MARGINAL
AX-2026-041921SNP-2602-U4281Janoshik2026-Q298.214.1892.9Buyer-sourced1MARGINAL
AX-2026-041922SNP-2602-U4281VendorInvestigate2026-Q297.883.6891.3Buyer-sourced1MARGINAL
Other recent Mazdutide records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042930MKMMKM-2511-N3837Janoshik2026-Q298.087.96Buyer-sourced1MARGINAL
AX-2026-042923MKMMKM-2511-N3837Janoshik2026-Q298.466.7297.9Buyer-sourced0PASS
AX-2026-042928MKMMKM-2511-N3837Janoshik2026-Q298.596.41Buyer-sourced0PASS
AX-2026-042926MKMMKM-2511-N3837Nordanalyt2026-Q298.676.6393.6Buyer-sourced0PASS
AX-2026-041921SinoPepSNP-2602-U4281Janoshik2026-Q298.214.1892.9Buyer-sourced1MARGINAL
AX-2026-041920SinoPepSNP-2602-U4281Janoshik2026-Q297.774.4188.7Buyer-sourced2MARGINAL
AX-2026-043118SSASSA-2605-G6892PeptideMeter2026-Q298.963.2598.7Buyer-sourced0PASS
AX-2026-042924MKMMKM-2511-N3837Nordanalyt2026-Q298.787.43Buyer-sourced0PASS
Other recent SinoPep records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041867CJC-1295 with DACSNP-2607-C3886Janoshik2026-Q399.245.12Laboratory-retained1FAIL
AX-2026-041913IpamorelinSNP-2606-L4478PeptideMeter2026-Q398.885.28Buyer-sourced0FAIL
AX-2026-041914IpamorelinSNP-2606-L4478Janoshik2026-Q399.145.49Buyer-sourced0PASS
AX-2026-041909IpamorelinSNP-2606-L4478PeptideMeter2026-Q399.005.4889.5Buyer-sourced1MARGINAL
AX-2026-041895IpamorelinSNP-2602-B3833Janoshik2026-Q399.934.72105.9Buyer-sourced1MARGINAL
AX-2026-041930IGF-1 LR3SNP-2606-D4620Medutest2026-Q398.545.3793.8Buyer-sourced0PASS
AX-2026-041898IpamorelinSNP-2602-B3833Nordanalyt2026-Q399.934.5496.0Buyer-sourced1MARGINAL
AX-2026-041931IGF-1 LR3SNP-2606-D4620PeptideMeter2026-Q397.935.1993.4Buyer-sourced0PASS