AssayIndex

AX-2025-021232

5-Amino-1MQ · 50 mg declared · PolyPeptide Group (Hangzhou) Co., Ltd. · lot PPG-2510-E7748

FAILPURITY ONLY
Report ID
AX-2025-021232
Compound
5-Amino-1MQ
Compound class
Non-peptide adjuncts
Supplier
PPG — PolyPeptide Group (Hangzhou) Co., Ltd.
Batch / lot
PPG-2510-E7748
Declared label claim
50mg
Laboratory
Janoshik Analytical
Assay date
31 Oct 2025
Submitted
20 Nov 2025
Quarter
2025-Q4
Submitter
so.broberg
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 nm99.38% area≥ 98.0PASS
Total impuritiesRP-HPLC, sum of reported peaks0.62% area≤ 2.0PASS
Largest single impurityRP-HPLC — 5-nitro-1MQ (unreduced precursor, +30 Da)0.39% area≤ 1.00PASS
Identitynot ordered on this submissionnot determinedrequired for VERIFIED statusNOT TESTED
Peptide contentnot ordered on this submissionnot determinedrequired to check label claimNOT TESTED
Water contentKarl Fischer, coulometric, duplicate3.03%≤ 10.0PASS
Counter-ion (iodide)anion-exchange ion chromatography36.40%≤ 12.0FAIL
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.96%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 calibration4.792.5 – 8.0PASS
Retention time (observed)RP-HPLC, 30 min gradient5.49min5.42 ± 0.25 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.020.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²73,684≥ 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.

05637112751691222549 5-Amino-1MQ5.49 min · 99.38 % 6.17 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 73,684, and skew follows the reported asymmetry factor of 1.02. 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 0.39 % impurity against a 99.38 % 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 peak5.494,830,17699.38
25-nitro-1MQ (unreduced precursor, +30 Da)6.1718,9550.39+29.974
3free iodide (counter-ion, by IC)5.494,8600.100.000
48-amino regioisomer5.713,8880.080.000
51-methylquinolinium (des-amino, −15 Da)5.172,4300.05-15.011
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 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)99.1799.38divergence -0.21 pp vs batch median
Total impurities (% area)not stated0.62
Largest single impurity (% area)not stated0.39
Water (%)2.63.03
Counter-ion (%)not stated36.40
Peptide content (%w/w)92.6not 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
Buyer-sourced
Evidentiary weight
Strongest available evidence in this index.
Chain of custody
Retail purchase → submitter (2–8 °C, 30 d) → laboratory (courier, ambient, 10 d) → assay.
Assay date
31 Oct 2025
Submitted to the index
20 Nov 2025
Laboratory
Janoshik Analytical, Ostrava, Czechia
Method basis
30 min gradient · high-resolution MS
Verification status
PURITY ONLY
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.

storage_stated
Stated storage conditions on the certificate against the observed transit conditions in the custody block: on this record they agree, which removes one class of explanation for anything unexpected.
valley_drop
Valley height relative to the smaller peak is the practical criterion an operator uses, and it is not on the report. Resolution is a proxy for it and an imperfect one on asymmetric pairs.
baseline_noise
On a low-resolution pair the baseline between the peaks never reaches baseline, so any integration is an extrapolation. Stating which extrapolation was used is worth more than any threshold.
Section 7

Related records

Same batch — lot PPG-2510-E7748 n=3

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2025-021230PPG-2510-E7748Janoshik2025-Q499.423.43104.1Buyer-sourced0FAIL
AX-2025-021231PPG-2510-E7748Janoshik2025-Q499.362.9893.8Buyer-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 PPG records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043598TesamorelinPPG-2608-A6835Kestrel2026-Q398.912.56100.3Buyer-sourced1FAIL
AX-2026-043597TesamorelinPPG-2608-A6835Janoshik2026-Q398.541.15Buyer-sourced0PASS
AX-2026-043596TesamorelinPPG-2608-A6835PeptideMeter2026-Q398.741.83105.1Buyer-sourced1MARGINAL
AX-2026-043605RetatrutidePPG-2604-X7060Janoshik2026-Q298.174.2999.7Buyer-sourced0PASS
AX-2026-043601RetatrutidePPG-2604-X7060Janoshik2026-Q298.283.9695.3Buyer-sourced0PASS
AX-2026-043668AOD-9604PPG-2602-W8018PeptideMeter2026-Q299.473.06Buyer-sourced0PASS
AX-2026-043670AOD-9604PPG-2602-W8018PeptideMeter2026-Q299.562.71104.5Buyer-sourced0PASS
AX-2026-043630CJC-1295 (no DAC)PPG-2512-D7211Janoshik2026-Q299.665.1192.5Buyer-sourced0PASS