AssayIndex

AX-2026-041606

Pinealon · 20 mg declared · Qingdao Sigma Chemical Co., Ltd. · lot QSC-2602-V8219

FAILMETHOD LIMITED
Report ID
AX-2026-041606
Compound
Pinealon
Compound class
Short bioregulator peptides
Supplier
QSC — Qingdao Sigma Chemical Co., Ltd.
Batch / lot
QSC-2602-V8219
Declared label claim
20mg
Laboratory
Janoshik Analytical
Assay date
13 Jun 2026
Submitted
15 Jun 2026
Quarter
2026-Q2
Submitter
me.hartmann
Sample provenance
Supplier-supplied
Section 1

Results

Measured against the index acceptance specification for the short bioregulator peptides 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 nm99.90% area≥ 99.0PASS
Total impuritiesRP-HPLC, sum of reported peaks0.10% area≤ 1.0PASS
Largest single impurityRP-HPLC — Asp-Arg dipeptide (−129 Da)0.04% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula418.1812DaNOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)418.1805DaNOT TESTED
Mass accuracyobserved vs theoretical-1.6ppm± 20PASS
Total peptide contentby difference from the gravimetric mass balance78.79%w/wNOT TESTED
Target-compound contenttotal peptide content × purity78.71%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen26.44mg20 mg declaredNOT TESTED
Recovered target peptidegross fill × target content20.811mg20 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim104.1%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate7.67%≤ 12.0PASS
Counter-ion (acetate)anion-exchange ion chromatography13.28%≤ 10.0FAIL
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 cake, partially collapsedwhite 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 calibration5.762.5 – 8.0PASS
Retention time (observed)RP-HPLC, 30 min gradient4.88min4.86 ± 0.20 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.460.900.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²64,190≥ 20,000PASS
Resolution to nearest impurityvs aspartimide (−18 Da)1.77no 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.

06320126391895925279 Pinealon4.88 min · 99.90 % 4.54 same trace · ×200 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 64,190, and skew follows the reported asymmetry factor of 0.90. 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 0.04 % impurity against a 99.90 % main peak is a line two pixels tall; the main peak runs off-scale there by design.
#PeakRTArea (µV·s)% areaΔ mass (Da)
1Pinealon — main peak4.884,855,45099.90
2Asp-Arg dipeptide (−129 Da)4.541,9440.04-129.043
3Glu-Asp dipeptide (−156 Da)4.581,4580.03-156.101
4aspartimide (−18 Da)5.021,4580.03-18.011
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 418.1812 Da, computed from C15H26N6O8. All ppm figures on this site are against monoisotopic values — see why that matters.

0255075100375400425450475500 [M+1H]1+419.19 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 418.1805 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+419.1885419.1878-0.0007100.0
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 Fischer7.67
Counter-ion (acetate)ion chromatography13.28
Residual solvent + inorganic residueestimated0.26
Total peptide contentby difference78.79
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)99.9099.90divergence -0.02 pp vs batch median
Total impurities (% area)0.100.10
Largest single impurity (% area)0.040.04
Water (%)6.77.67
Counter-ion (%)not stated13.28
Peptide content (%w/w)not stated78.79
Endotoxin (EU/mg)1.43not 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, 6 d) → assay. Submitter did not handle the vial.
Assay date
13 Jun 2026
Submitted to the index
15 Jun 2026
Laboratory
Janoshik Analytical, Ostrava, Czechia
Method basis
30 min gradient · high-resolution MS
Verification status
METHOD LIMITED
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 QSC-2602-V8219 n=4

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041607QSC-2602-V8219Janoshik2026-Q299.937.46Supplier-supplied0FAIL
AX-2026-041608QSC-2602-V8219VendorInvestigate2026-Q299.937.95106.0Buyer-sourced0PASS
AX-2026-041609QSC-2602-V8219VendorInvestigate2026-Q299.837.58Buyer-sourced0FAIL
Other recent Pinealon records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041609QSCQSC-2602-V8219VendorInvestigate2026-Q299.837.58Buyer-sourced0FAIL
AX-2026-041608QSCQSC-2602-V8219VendorInvestigate2026-Q299.937.95106.0Buyer-sourced0PASS
AX-2026-041607QSCQSC-2602-V8219Janoshik2026-Q299.937.46Supplier-supplied0FAIL
AX-2025-019058JEEPJEEP-2507-B3026PeptideMeter2025-Q499.9310.2394.5Supplier-supplied0FAIL
AX-2024-005377CPCCPC-2403-R3097Janoshik2024-Q299.347.93Supplier-supplied1FAIL
AX-2024-005380CPCCPC-2403-R3097Janoshik2024-Q299.248.6690.1Supplier-supplied1MARGINAL
AX-2024-005389CPCCPC-2403-R3097VendorInvestigate2024-Q298.538.2495.9Buyer-sourced1FAIL
AX-2024-005381CPCCPC-2403-R3097Janoshik2024-Q299.068.5291.9Supplier-supplied1MARGINAL
Other recent QSC records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041683CJC-1295 (no DAC)QSC-2606-V8637Janoshik2026-Q399.933.6397.1Supplier-supplied1FAIL
AX-2026-041727CJC-1295 with DACQSC-2602-E9474Janoshik2026-Q398.886.62105.3Supplier-supplied1MARGINAL
AX-2026-041728CJC-1295 with DACQSC-2602-E9474VendorInvestigate2026-Q398.427.04Buyer-sourced1MARGINAL
AX-2026-041734CJC-1295 with DACQSC-2602-E9474Medutest2026-Q399.437.17105.5Supplier-supplied2FAIL
AX-2026-041652LiraglutideQSC-2605-W8602Nordanalyt2026-Q399.336.55Supplier-supplied0PASS
AX-2026-041730CJC-1295 with DACQSC-2602-E9474PeptideMeter2026-Q398.796.9395.4Supplier-supplied1MARGINAL
AX-2026-041686CJC-1295 (no DAC)QSC-2606-V8637Janoshik2026-Q399.934.04Supplier-supplied0PASS
AX-2026-041653LiraglutideQSC-2605-W8602VendorInvestigate2026-Q398.825.95Buyer-sourced0PASS