AssayIndex

AX-2026-042581

SLU-PP-332 · 25 mg declared · Nantong Guangyuan Chemical Co., Ltd. · lot GGPE-2511-R8569

MARGINALIDENTITY CONSISTENT
Report ID
AX-2026-042581
Compound
SLU-PP-332
Compound class
Non-peptide adjuncts
Supplier
GGPeps — Nantong Guangyuan Chemical Co., Ltd.
Batch / lot
GGPE-2511-R8569
Declared label claim
25mg
Laboratory
Medutest
Assay date
24 Jun 2026
Submitted
01 Jul 2026
Quarter
2026-Q2
Submitter
ay.ibarra
Sample provenance
Supplier-supplied
Section 1

Results

Measured against the index acceptance specification for the non-peptide adjuncts 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 nm98.80% area≥ 98.0PASS
Total impuritiesRP-HPLC, sum of reported peaks1.20% area≤ 2.0PASS
Largest single impurityRP-HPLC — hydrolysed ester (+18 Da)0.64% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula410.1300DaNOT TESTED
Identity — observed monoisotopic massLC-MS, unit resolution (single quadrupole)410.1290DaNOT TESTED
Mass accuracyobserved vs theoretical-2.4ppm± 10PASS
Total peptide contentby difference from the gravimetric mass balance95.07%w/wNOT TESTED
Target-compound contenttotal peptide content × purity93.93%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen28.23mg25 mg declaredNOT TESTED
Recovered target peptidegross fill × target content26.516mg25 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim106.1%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate4.69%≤ 10.0PASS
Counter-ionno ionisable counter-ion expectedN/Anot applicableNOT TESTED
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.24%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 calibration6.682.5 – 8.0PASS
Retention time (observed)RP-HPLC, 25 min gradient12.97min12.94 ± 0.35 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.110.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²87,897≥ 20,000PASS
Resolution to nearest impurityvs des-methyl analogue (−14 Da)1.67no 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.

02478495674349912 SLU-PP-33212.97 min · 98.80 % 11.944.55 same trace · ×100 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 87,897, and skew follows the reported asymmetry factor of 1.11. 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 0.64 % impurity against a 98.80 % main peak is a line two pixels tall; the main peak runs off-scale there by design.
#PeakRTArea (µV·s)% areaΔ mass (Da)
1SLU-PP-332 — main peak12.974,801,98698.80
2hydrolysed ester (+18 Da)11.9431,1060.64+18.011
3sulfoxide (+16 Da)12.3712,6370.26+15.995
4des-methyl analogue (−14 Da)12.678,2630.17-14.016
5residual DMSO (process solvent)4.556,3180.130.000
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 410.1300 Da, computed from C22H22N2O4S. All ppm figures on this site are against monoisotopic values — see why that matters.

0255075100375400425450475500 [M+1H]1+411.14 m/z Relative abundance (%)
Figure 2. ESI charge-state envelope, unit-resolution instrument. Sticks are placed at m/z = (M + z × 1.007276)/z for the observed neutral mass of 410.1290 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 (%)
1+411.1373411.1363-0.0010100.0
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 Fischer4.69
Counter-ionnone expected0.00
Residual solvent + inorganic residueestimated0.24
Total peptide contentby difference95.07
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)99.098.80divergence +0.35 pp vs batch median
Total impurities (% area)1.001.20
Largest single impurity (% area)not stated0.64
Water (%)not stated4.69
Counter-ion (%)not statedN/A
Peptide content (%w/w)not stated95.07
Endotoxin (EU/mg)not statednot determined
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
Supplier-supplied
Evidentiary weight
Weaker evidence. Read with the caveat below.
Chain of custody
Supplier despatch → laboratory direct (courier, cold pack, 7 d) → assay. Submitter did not handle the vial.
Assay date
24 Jun 2026
Submitted to the index
01 Jul 2026
Laboratory
Medutest, Ljubljana, Slovenia
Method basis
25 min gradient · unit-resolution MS
Verification status
IDENTITY CONSISTENT
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 GGPE-2511-R8569 n=12

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042578GGPE-2511-R8569Janoshik2026-Q298.314.42101.5Laboratory-retained1MARGINAL
AX-2026-042579GGPE-2511-R8569Medutest2026-Q298.585.09104.0Buyer-sourced1MARGINAL
AX-2026-042580GGPE-2511-R8569PeptideMeter2026-Q298.674.40Supplier-supplied1MARGINAL
AX-2026-042582GGPE-2511-R8569Janoshik2026-Q298.984.56Supplier-supplied1MARGINAL
AX-2026-042583GGPE-2511-R8569Janoshik2026-Q298.924.1191.2Supplier-supplied1MARGINAL
AX-2026-042584GGPE-2511-R8569Medutest2026-Q298.394.38Supplier-supplied3FAIL
AX-2026-042585GGPE-2511-R8569Janoshik2026-Q298.634.3288.8Supplier-supplied2MARGINAL
AX-2026-042586GGPE-2511-R8569Medutest2026-Q298.354.78101.6Buyer-sourced1MARGINAL
AX-2026-042587GGPE-2511-R8569PeptideMeter2026-Q298.544.88106.2Supplier-supplied1MARGINAL
AX-2026-042588GGPE-2511-R8569Janoshik2026-Q299.254.2888.7Supplier-supplied3MARGINAL
AX-2026-042589GGPE-2511-R8569Janoshik2026-Q298.754.2890.1Supplier-supplied1MARGINAL
Other recent SLU-PP-332 records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042278HomopeptideHOMO-2602-Y2822Kestrel2026-Q399.714.42Supplier-supplied0PASS
AX-2026-042274HomopeptideHOMO-2602-Y2822VendorInvestigate2026-Q398.714.72Laboratory-retained0PASS
AX-2026-042276HomopeptideHOMO-2602-Y2822Janoshik2026-Q399.584.95Supplier-supplied0PASS
AX-2026-042279HomopeptideHOMO-2602-Y2822Janoshik2026-Q399.274.6290.9Supplier-supplied0PASS
AX-2026-042280HomopeptideHOMO-2602-Y2822VendorInvestigate2026-Q399.165.05105.8Buyer-sourced0PASS
AX-2026-042273HomopeptideHOMO-2602-Y2822PeptideMeter2026-Q399.814.6088.9Supplier-supplied2MARGINAL
AX-2026-042275HomopeptideHOMO-2602-Y2822Nordanalyt2026-Q399.445.2492.5Buyer-sourced0PASS
AX-2026-042277HomopeptideHOMO-2602-Y2822Janoshik2026-Q399.574.7998.8Supplier-supplied0PASS
Other recent GGPeps records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042737SelankGGPE-2603-J9708Janoshik2026-Q398.409.1497.4Buyer-sourced0FAIL
AX-2026-042804SelankGGPE-2602-G2056Janoshik2026-Q398.507.97Supplier-supplied0FAIL
AX-2026-042803SelankGGPE-2602-G2056Janoshik2026-Q398.488.01Laboratory-retained1FAIL
AX-2026-042802SelankGGPE-2602-G2056Janoshik2026-Q398.747.0996.0Supplier-supplied0FAIL
AX-2026-042796SelankGGPE-2602-G2056Janoshik2026-Q398.267.5697.5Buyer-sourced0FAIL
AX-2026-042648Melanotan IIGGPE-2603-P8735Janoshik2026-Q399.106.97Supplier-supplied4MARGINAL
AX-2026-042797SelankGGPE-2602-G2056Medutest2026-Q398.467.92Buyer-sourced0FAIL
AX-2026-042669CJC-1295 (no DAC)GGPE-2606-E8495Medutest2026-Q398.614.0695.5Supplier-supplied0PASS