AssayIndex

AX-2026-042970

5-Amino-1MQ · 50 mg declared · Zhuhai Kerui Biotechnology Co., Ltd. · lot KP-2511-W4792

FAILPURITY ONLY
Report ID
AX-2026-042970
Compound
5-Amino-1MQ
Compound class
Non-peptide adjuncts
Supplier
KP — Zhuhai Kerui Biotechnology Co., Ltd.
Batch / lot
KP-2511-W4792
Declared label claim
50mg
Laboratory
Janoshik Analytical
Assay date
25 May 2026
Submitted
02 Jun 2026
Quarter
2026-Q2
Submitter
e.nwosu
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 nm98.89% area≥ 98.0PASS
Total impuritiesRP-HPLC, sum of reported peaks1.11% area≤ 2.0PASS
Largest single impurityRP-HPLC — 1-methylquinolinium (des-amino, −15 Da)0.77% area≤ 1.00PASS
Identitynot ordered on this submissionnot determinedrequired for VERIFIED statusNOT TESTED
Total peptide contentby difference from the gravimetric mass balance50.55%w/wNOT TESTED
Target-compound contenttotal peptide content × purity49.99%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen90.97mg50 mg declaredNOT TESTED
Recovered target peptidegross fill × target content45.476mg50 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim91.0%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate4.03%≤ 10.0PASS
Counter-ion (iodide)anion-exchange ion chromatography45.13%≤ 12.0FAIL
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.29%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 calibration5.152.5 – 8.0PASS
Retention time (observed)RP-HPLC, 30 min gradient5.30min5.42 ± 0.25 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.070.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²40,667≥ 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.

0421184221263416845 5-Amino-1MQ5.30 min · 98.89 % 4.98 same trace · ×50 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 40,667, and skew follows the reported asymmetry factor of 1.07. 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 0.77 % impurity against a 98.89 % 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 peak5.304,806,36198.89
21-methylquinolinium (des-amino, −15 Da)4.9837,4240.77-15.011
38-amino regioisomer5.529,7210.200.000
45-nitro-1MQ (unreduced precursor, +30 Da)5.983,4020.07+29.974
5free iodide (counter-ion, by IC)5.303,4020.070.000
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 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 Fischer4.03
Counter-ion (iodide)ion chromatography45.13
Residual solvent + inorganic residueestimated0.29
Total peptide contentby difference50.55
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)99.098.89divergence -0.33 pp vs batch median
Total impurities (% area)1.001.11
Largest single impurity (% area)0.680.77
Water (%)2.04.03
Counter-ion (%)not stated45.13
Peptide content (%w/w)not stated50.55
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, 10 d) → assay. Submitter did not handle the vial.
Assay date
25 May 2026
Submitted to the index
02 Jun 2026
Laboratory
Janoshik Analytical, Ostrava, Czechia
Method basis
30 min gradient · high-resolution MS
Verification status
PURITY ONLY
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 KP-2511-W4792 n=5

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042967KP-2511-W4792Janoshik2026-Q299.494.14Supplier-supplied2FAIL
AX-2026-042968KP-2511-W4792Janoshik2026-Q298.874.3291.5Buyer-sourced2FAIL
AX-2026-042969KP-2511-W4792Janoshik2026-Q299.333.94Buyer-sourced2FAIL
AX-2026-042971KP-2511-W4792Janoshik2026-Q299.454.19107.1Supplier-supplied2FAIL
Other recent 5-Amino-1MQ records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042753GGPepsGGPE-2512-M9695Medutest2026-Q299.214.6193.5Supplier-supplied2FAIL
AX-2026-042969KPKP-2511-W4792Janoshik2026-Q299.333.94Buyer-sourced2FAIL
AX-2026-042967KPKP-2511-W4792Janoshik2026-Q299.494.14Supplier-supplied2FAIL
AX-2026-042754GGPepsGGPE-2512-M9695PeptideMeter2026-Q299.204.9096.8Supplier-supplied2FAIL
AX-2026-042971KPKP-2511-W4792Janoshik2026-Q299.454.19107.1Supplier-supplied2FAIL
AX-2026-042968KPKP-2511-W4792Janoshik2026-Q298.874.3291.5Buyer-sourced2FAIL
AX-2026-042012TFCTFC-2508-L6321Janoshik2026-Q199.935.8495.7Supplier-supplied0FAIL
AX-2026-042013TFCTFC-2508-L6321PeptideMeter2026-Q199.905.7890.3Supplier-supplied0FAIL
Other recent KP records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043029RetatrutideKP-2607-H5219Medutest2026-Q395.455.71Supplier-supplied2FAIL
AX-2026-043030RetatrutideKP-2607-H5219Kestrel2026-Q395.976.9597.1Supplier-supplied2FAIL
AX-2026-043106TirzepatideKP-2608-D5921PeptideMeter2026-Q398.905.45105.4Supplier-supplied2MARGINAL
AX-2026-043108TirzepatideKP-2608-D5921Janoshik2026-Q399.705.45Supplier-supplied2MARGINAL
AX-2026-043039RetatrutideKP-2607-H5219Janoshik2026-Q396.145.62Supplier-supplied2FAIL
AX-2026-043100TirzepatideKP-2608-D5921VendorInvestigate2026-Q398.275.3194.4Buyer-sourced2MARGINAL
AX-2026-043090IpamorelinKP-2606-D5887Janoshik2026-Q398.183.07101.2Laboratory-retained1FAIL
AX-2026-043028RetatrutideKP-2607-H5219Janoshik2026-Q396.526.09Supplier-supplied2MARGINAL