AssayIndex

AX-2026-042276

SLU-PP-332 · 10 mg declared · Hunan Aslsen Technology Co., Ltd. · lot HOMO-2602-Y2822

PASSIDENTITY CONSISTENT
Report ID
AX-2026-042276
Compound
SLU-PP-332
Compound class
Non-peptide adjuncts
Supplier
Homopeptide — Hunan Aslsen Technology Co., Ltd.
Batch / lot
HOMO-2602-Y2822
Declared label claim
10mg
Laboratory
Janoshik Analytical
Assay date
21 Aug 2026
Submitted
14 Sep 2026
Quarter
2026-Q3
Submitter
r.sjoberg
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, 30 min gradient, 214 nm99.58% area≥ 98.0PASS
Total impuritiesRP-HPLC, sum of reported peaks0.42% area≤ 2.0PASS
Largest single impurityRP-HPLC — hydrolysed ester (+18 Da)0.15% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula410.1300DaNOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)410.1306DaNOT TESTED
Mass accuracyobserved vs theoretical+1.5ppm± 10PASS
Peptide contentnot ordered on this submissionnot determinedrequired to check label claimNOT TESTED
Water contentKarl Fischer, coulometric, duplicate4.95%≤ 10.0PASS
Counter-ionno ionisable counter-ion expectedN/Anot applicableNOT TESTED
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.73%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 cake, partially collapsedwhite to off-white intact cakeFAIL
Reconstitution clarityreconstituted per submitter procedureClear with a single visible fibreclear, no visible particulatesFAIL
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration7.712.5 – 8.0PASS
Retention time (observed)RP-HPLC, 30 min gradient15.18min15.28 ± 0.35 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.460.950.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²74,915≥ 20,000PASS
Resolution to nearest impurityvs des-methyl analogue (−14 Da)1.58no 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.

02132426363958527 SLU-PP-33215.18 min · 99.58 % 5.0813.94 same trace · ×100 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 74,915, and skew follows the reported asymmetry factor of 0.95. 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 0.15 % impurity against a 99.58 % 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 peak15.184,839,89799.58
2hydrolysed ester (+18 Da)13.947,2900.15+18.011
3residual DMSO (process solvent)5.086,8040.140.000
4sulfoxide (+16 Da)14.463,8880.08+15.995
5des-methyl analogue (−14 Da)14.822,4300.05-14.016
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, high-resolution instrument. Sticks are placed at m/z = (M + z × 1.007276)/z for the observed neutral mass of 410.1306 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+411.1373411.13790.0006100.0
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.

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)99.9099.58divergence +0.39 pp vs batch median
Total impurities (% area)0.100.42
Largest single impurity (% area)0.060.15
Water (%)3.74.95
Counter-ion (%)4.4N/A
Peptide content (%w/w)91.3not determined
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
Supplier-supplied
Evidentiary weight
Weaker evidence. Read with the caveat below.
Chain of custody
Supplier despatch → laboratory direct (courier, cold pack, 12 d) → assay. Submitter did not handle the vial.
Assay date
21 Aug 2026
Submitted to the index
14 Sep 2026
Laboratory
Janoshik Analytical, Ostrava, Czechia
Method basis
30 min gradient · high-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 HOMO-2602-Y2822 n=8

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042273HOMO-2602-Y2822PeptideMeter2026-Q399.814.6088.9Supplier-supplied2MARGINAL
AX-2026-042274HOMO-2602-Y2822VendorInvestigate2026-Q398.714.72Laboratory-retained0PASS
AX-2026-042275HOMO-2602-Y2822Nordanalyt2026-Q399.445.2492.5Buyer-sourced0PASS
AX-2026-042277HOMO-2602-Y2822Janoshik2026-Q399.574.7998.8Supplier-supplied0PASS
AX-2026-042278HOMO-2602-Y2822Kestrel2026-Q399.714.42Supplier-supplied0PASS
AX-2026-042279HOMO-2602-Y2822Janoshik2026-Q399.274.6290.9Supplier-supplied0PASS
AX-2026-042280HOMO-2602-Y2822VendorInvestigate2026-Q399.165.05105.8Buyer-sourced0PASS
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-2026-042279HomopeptideHOMO-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
AX-2026-042579GGPepsGGPE-2511-R8569Medutest2026-Q298.585.09104.0Buyer-sourced1MARGINAL
Other recent Homopeptide records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042181IpamorelinHOMO-2608-A9045Janoshik2026-Q399.784.79Supplier-supplied1MARGINAL
AX-2026-042172SemaglutideHOMO-2604-X8921Janoshik2026-Q399.645.1691.9Supplier-supplied1MARGINAL
AX-2026-042278SLU-PP-332HOMO-2602-Y2822Kestrel2026-Q399.714.42Supplier-supplied0PASS
AX-2026-042180IpamorelinHOMO-2608-A9045Janoshik2026-Q399.394.74105.5Supplier-supplied1MARGINAL
AX-2026-042184IpamorelinHOMO-2608-A9045Kestrel2026-Q399.274.79103.2Supplier-supplied1MARGINAL
AX-2026-042274SLU-PP-332HOMO-2602-Y2822VendorInvestigate2026-Q398.714.72Laboratory-retained0PASS
AX-2026-042183IpamorelinHOMO-2608-A9045VendorInvestigate2026-Q399.384.97Buyer-sourced1MARGINAL
AX-2026-042194RetatrutideHOMO-2605-V9833PeptideMeter2026-Q398.904.0798.8Supplier-supplied3MARGINAL