AssayIndex

AX-2024-004392

5-Amino-1MQ · 100 mg declared · Thermo Fisher Scientific (China) Co., Ltd. · lot TFS-{CAT}-1476

FAILVERIFIED
Report ID
AX-2024-004392
Compound
5-Amino-1MQ
Compound class
Non-peptide adjuncts
Supplier
TFS — Thermo Fisher Scientific (China) Co., Ltd.
Batch / lot
TFS-{CAT}-1476
Declared label claim
100mg
Laboratory
Janoshik Analytical
Assay date
24 Dec 2024
Submitted
31 Dec 2024
Quarter
2024-Q4
Submitter
m.vermeulen
Sample provenance
Buyer-sourced
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 nm99.54% area≥ 98.0PASS
Total impuritiesRP-HPLC, sum of reported peaks0.46% area≤ 2.0PASS
Largest single impurityRP-HPLC — 1-methylquinolinium (des-amino, −15 Da)0.29% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula285.9967DaNOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)285.9972DaNOT TESTED
Mass accuracyobserved vs theoretical+1.9ppm± 10PASS
Peptide contentnot ordered on this submissionnot determinedrequired to check label claimNOT TESTED
Water contentKarl Fischer, coulometric, duplicate5.84%≤ 10.0PASS
Counter-ion (iodide)anion-exchange ion chromatography42.75%≤ 12.0FAIL
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.71%NOT TESTED
Endotoxinkinetic chromogenic LAL0.27EU/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 calibration5.172.5 – 8.0PASS
Retention time (observed)RP-HPLC, 30 min gradient5.34min5.42 ± 0.25 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.110.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²52,263≥ 20,000PASS
Resolution to nearest impurityvs free iodide (counter-ion, by IC)0.00no 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.

0468093611404118722 5-Amino-1MQ5.34 min · 99.54 % 5.02 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 52,263, 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 0.29 % impurity against a 99.54 % main peak is a line two pixels tall; the main peak runs off-scale there by design.
#PeakRTArea (µV·s)% areaΔ mass (Da)
15-Amino-1MQ — main peak5.344,837,95399.54
21-methylquinolinium (des-amino, −15 Da)5.0214,0950.29-15.011
3free iodide (counter-ion, by IC)5.344,8600.100.000
45-nitro-1MQ (unreduced precursor, +30 Da)6.021,9440.04+29.974
58-amino regioisomer5.561,4580.030.000
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 285.9967 Da, computed from C10H11N2+ · I−. All ppm figures on this site are against monoisotopic values — see why that matters.

0255075100250275300325350375 [M+1H]1+287.00 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 285.9972 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+287.0040287.00450.0005100.0
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)99.9099.54divergence +0.08 pp vs batch median
Total impurities (% area)0.100.46
Largest single impurity (% area)0.070.29
Water (%)not stated5.84
Counter-ion (%)not stated42.75
Peptide content (%w/w)not statednot determined
Endotoxin (EU/mg)0.250.27
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 → third-party forwarder (29 d) → laboratory (courier, cold pack, 8 d) → assay.
Assay date
24 Dec 2024
Submitted to the index
31 Dec 2024
Laboratory
Janoshik Analytical, Ostrava, Czechia
Method basis
30 min gradient · high-resolution MS
Verification status
VERIFIED
Section 6

Annotations 3

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.

median_not_mean
One result at the top of the distribution should not move anybody's estimate much on its own. Purity distributions are compressed at the top and long-tailed at the bottom, so the informative observations are the low ones.
buyer_sourced
Buyer-sourced through an ordinary retail order, so the supplier had no opportunity to select the vial. This is the provenance class the index weights and it is roughly 87 % of the dataset.
shipping_temp
A data logger in the box would upgrade this record further. Custody is documented; temperature history is inferred, and inference is weaker than measurement.
Section 7

Related records

Same batch — lot TFS-{CAT}-1476 n=4

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2025-018932TFS-{CAT}-1476Janoshik2024-Q499.935.15Buyer-sourced0FAIL
AX-2024-004393TFS-{CAT}-1476Kestrel2024-Q499.935.22102.0Buyer-sourced1FAIL
AX-2024-004394TFS-{CAT}-1476Janoshik2024-Q499.715.09Buyer-sourced0FAIL
Other recent 5-Amino-1MQ records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043050KPKP-2511-W5347Janoshik2026-Q299.354.16105.5Buyer-sourced0FAIL
AX-2026-043044KPKP-2511-W5347PeptideMeter2026-Q299.614.1590.9Buyer-sourced0FAIL
AX-2026-043052KPKP-2511-W5347Medutest2026-Q299.454.23105.5Buyer-sourced1FAIL
AX-2026-043045KPKP-2511-W5347Janoshik2026-Q299.474.08Buyer-sourced0FAIL
AX-2026-043043KPKP-2511-W5347Janoshik2026-Q299.584.16101.1Buyer-sourced0FAIL
AX-2026-042869GGPepsGGPE-2512-M2434Kestrel2026-Q299.554.65103.9Buyer-sourced0FAIL
AX-2026-042868GGPepsGGPE-2512-M2434PeptideMeter2026-Q299.324.3988.5Buyer-sourced1FAIL
AX-2026-043047KPKP-2511-W5347Janoshik2026-Q299.684.17104.0Supplier-supplied0FAIL
Other recent TFS records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041681CJC-1295 with DACTFS-{CAT}-9675PeptideMeter2026-Q398.823.67Buyer-sourced0PASS
AX-2026-041766BPC-157TFS-{CAT}-1156Janoshik2026-Q399.546.34Buyer-sourced1MARGINAL
AX-2026-041682CJC-1295 with DACTFS-{CAT}-9675Nordanalyt2026-Q398.943.24Buyer-sourced0PASS
AX-2026-041683CJC-1295 with DACTFS-{CAT}-9675Medutest2026-Q398.683.4697.0Buyer-sourced0PASS
AX-2026-041765BPC-157TFS-{CAT}-1156Janoshik2026-Q399.796.01Buyer-sourced0PASS
AX-2026-041680CJC-1295 with DACTFS-{CAT}-9675Medutest2026-Q399.182.85100.4Buyer-sourced0PASS
AX-2026-041691SemaglutideTFS-{CAT}-9744Janoshik2026-Q298.316.0791.4Buyer-sourced0PASS
AX-2026-041700SS-31 (Elamipretide)TFS-{CAT}-1142Medutest2026-Q299.752.2796.3Buyer-sourced0PASS