AssayIndex

AX-2026-041833

Survodutide · 10 mg declared · GenScript Biotech Corporation · lot GSP-2603-E3156

PASSVERIFIED
Report ID
AX-2026-041833
Compound
Survodutide
Compound class
Incretin analogues and co-agonists
Supplier
GSP — GenScript Biotech Corporation
Batch / lot
GSP-2603-E3156
Declared label claim
10mg
Laboratory
Janoshik Analytical
Assay date
29 Aug 2026
Submitted
08 Sep 2026
Quarter
2026-Q3
Submitter
survodutide_mixup
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 nm98.08% area≥ 96.5PASS
Total impuritiesRP-HPLC, sum of reported peaks1.92% area≤ 3.5PASS
Largest single impurityRP-HPLC — truncated (2-39)1.21% area≤ 1.00FAIL
Identity — theoretical monoisotopic masscalculated from molecular formula4764.5121Da—NOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)4764.5073Da—NOT TESTED
Mass accuracyobserved vs theoretical-1.0ppm± 15PASS
Total peptide contentby difference from the gravimetric mass balance87.35%w/w—NOT TESTED
Target-compound contenttotal peptide content × purity85.67%w/w—NOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen11.59mg10 mg declaredNOT TESTED
Recovered target peptidegross fill × target content9.929mg10 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim99.3%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate4.91%≤ 8.0PASS
Counter-ion (TFA)anion-exchange ion chromatography7.45%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.29%—NOT TESTED
Endotoxinkinetic chromogenic LAL0.40EU/mg≤ 5.0PASS
Sterilitymembrane filtration, USP <71>, 14 dNo growth at 14 d—no growthPASS
Appearancevisual, diffuse light, black and white backgroundOff-white lyophilised cake, intact—white to off-white intact cakePASS
Reconstitution clarityreconstituted per submitter procedureClear, colourless, no visible particulates—clear, no visible particulatesPASS
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration3.85—2.5 – 8.0PASS
Retention time (observed)RP-HPLC, 30 min gradient20.24min20.14 ± 0.50 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.13—0.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²52,310—≥ 20,000PASS
Resolution to nearest impurityvs [D-Ser2]-diastereomer0.72—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.

01205241036144819 Survodutide20.24 min · 98.08 % 18.8820.8624.29 same trace · ×50 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 52,310, and skew follows the reported asymmetry factor of 1.13. 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 1.21 % impurity against a 98.08 % main peak is a line two pixels tall; the main peak runs off-scale there by design.
#PeakRTArea (µV·s)% areaΔ mass (Da)
1Survodutide — main peak20.244,766,99298.08—
2truncated (2-39)18.8858,8101.21-137.059
3[D-Ser2]-diastereomer19.9816,5250.340.000
4aspartimide (−18 Da)20.869,7210.20-18.011
5C18 diacid mono-ester21.684,3740.09+14.016
6des-γGlu linker (−129 Da)19.292,4300.05-129.043
7survodutide dimer24.291,4580.03+4764.512
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 4764.5121 Da, computed from C220H340N50O67. All ppm figures on this site are against monoisotopic values — see why that matters.

0255075100550750950115013501550 [M+5H]5+953.91[M+4H]4+1192.13[M+6H]6+795.09 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 4764.5073 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+681.6519681.6512-0.00078.5
6+795.0926795.0918-0.000853.1
5+953.9097953.9087-0.0010100.0
4+1192.13531192.1341-0.001257.3
3+1589.17801589.1764-0.00167.9
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 Fischer4.91
Counter-ion (TFA)ion chromatography7.45
Residual solvent + inorganic residueestimated0.29
Total peptide contentby difference87.35
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)98.7998.08divergence +0.47 pp vs batch median
Total impurities (% area)not stated1.92
Largest single impurity (% area)not stated1.21
Water (%)not stated4.91
Counter-ion (%)2.77.45
Peptide content (%w/w)98.487.35
Endotoxin (EU/mg)not stated0.40
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 (−20 °C, 21 d) → laboratory (courier, dry ice, 6 d) → assay.
Assay date
29 Aug 2026
Submitted to the index
08 Sep 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.

label_claim
A retail vial is also a test of the label. Declared claim 10 mg against what the gravimetry recovers is a question only a purchased vial can answer honestly.
low_n
Strong provenance does not fix small n. One well-sourced record is still one record, and the batch page says how many others exist for GSP-2603-E3156.
Section 7

Related records

Same batch — lot GSP-2603-E3156 n=8

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041831GSP-2603-E3156Kestrel2026-Q399.915.5093.2Buyer-sourced0PASS
AX-2026-041832GSP-2603-E3156VendorInvestigate2026-Q398.015.1499.5Buyer-sourced0PASS
AX-2026-041834GSP-2603-E3156VendorInvestigate2026-Q397.925.95—Buyer-sourced0PASS
AX-2026-041835GSP-2603-E3156Nordanalyt2026-Q398.345.7489.0Buyer-sourced1MARGINAL
AX-2026-041836GSP-2603-E3156Janoshik2026-Q398.655.3490.3Buyer-sourced0PASS
AX-2026-041837GSP-2603-E3156Janoshik2026-Q398.335.37—Buyer-sourced0PASS
AX-2026-041838GSP-2603-E3156PeptideMeter2026-Q398.305.01102.4Buyer-sourced0PASS

Cross-sections

Other recent Survodutide records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041831GSPGSP-2603-E3156Kestrel2026-Q399.915.5093.2Buyer-sourced0PASS
AX-2026-042706ERPERP-2605-E9865PeptideMeter2026-Q398.385.33103.5Buyer-sourced0PASS
AX-2026-041836GSPGSP-2603-E3156Janoshik2026-Q398.655.3490.3Buyer-sourced0PASS
AX-2026-041837GSPGSP-2603-E3156Janoshik2026-Q398.335.37—Buyer-sourced0PASS
AX-2026-041832GSPGSP-2603-E3156VendorInvestigate2026-Q398.015.1499.5Buyer-sourced0PASS
AX-2026-041835GSPGSP-2603-E3156Nordanalyt2026-Q398.345.7489.0Buyer-sourced1MARGINAL
AX-2026-041834GSPGSP-2603-E3156VendorInvestigate2026-Q397.925.95—Buyer-sourced0PASS
AX-2026-041838GSPGSP-2603-E3156PeptideMeter2026-Q398.305.01102.4Buyer-sourced0PASS
Other recent GSP records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041831SurvodutideGSP-2603-E3156Kestrel2026-Q399.915.5093.2Buyer-sourced0PASS
AX-2026-041836SurvodutideGSP-2603-E3156Janoshik2026-Q398.655.3490.3Buyer-sourced0PASS
AX-2026-041837SurvodutideGSP-2603-E3156Janoshik2026-Q398.335.37—Buyer-sourced0PASS
AX-2026-041832SurvodutideGSP-2603-E3156VendorInvestigate2026-Q398.015.1499.5Buyer-sourced0PASS
AX-2026-041835SurvodutideGSP-2603-E3156Nordanalyt2026-Q398.345.7489.0Buyer-sourced1MARGINAL
AX-2026-041834SurvodutideGSP-2603-E3156VendorInvestigate2026-Q397.925.95—Buyer-sourced0PASS
AX-2026-041838SurvodutideGSP-2603-E3156PeptideMeter2026-Q398.305.01102.4Buyer-sourced0PASS
AX-2026-041824SemaglutideGSP-2512-H2838Janoshik2026-Q298.875.2696.4Buyer-sourced0PASS