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Certificate no.
PL-26-00127
Verification key
TFJEJK24
Scan or enter both at prymalab.net/testing/verify
Certificate of Analysis · Lot release
5-Amino-1MQ 50 mg/mL Pen
Lot PL-2610-004 · Solution · Label claim 50 mg/mL
Tested in-house by PrymaLab
In-house analytical result, not an independent third-party test
Lot / batch number
PL-2610-004
Date made
2026-10-01
Date of analysis
2026-10-02
Date issued
2026-10-16
Retest / expiry
2028-10-01
Units in lot / sampled
276 / 2
Storage
—
Certificate type
Lot COA, 2 pages
Compound
5-Amino-1MQ
5-Amino-1-methylquinolinium iodide (NNMT inhibitor); small molecule, not a peptide
CAS number
42464-96-0
Molecular formula
C10H11N2·I (cation C10H11N2+)
Theoretical mass (avg.)
286.11 Da (iodide salt) · 159.09 Da (cation)
Structure
5-Amino-1-methylquinolinium iodide; the 159.09 Da cation is the species observed by ESI-MS
Purity · RP-HPLC, area %
99.75%
Specification ≥ 99.0% • main peak at 10.37 min
Identity · Observed Mass
159.10 Da
Theoretical cation 159.09 Da • +0.01 Da (63 ppm)
Overall conclusion
PASS
Meets every specification for the tests performed
Test
Method
Specification
Result
Conclusion
Identity (mass)
LC-MS, ESI positive
Theoretical ± 1.0 Da
159.10 Da
PASS
Purity
RP-HPLC, UV 254–306 nm, area%
≥ 99.0%
99.75%
PASS
Largest impurity
RP-HPLC, area%
≤ 1.0%
0.11% (RT 11.63)
PASS
Assay (label claim)
Assay vs label claim
47.5–52.5 mg/mL
50.38 mg/mL
PASS
Bacterial endotoxin
LAL, kinetic
≤ 5.0 EU/mg
0.360 EU/mg
PASS
Sterility
USP <71>, 14-day
No growth
No growth
PASS
1HPLC chromatogram
Data file: PL-2610-004-HPLC.raw · Column C18, 150 × 4.6 mm · UV 254–306 nm
Peak plot drawn from the integrated peak table (area %, log scale); it is not the instrument trace, which is retained in PL-2610-004-HPLC.raw. † Nominal reference retention time for the assigned impurity; the main-peak RT is observed in this lot.
PrymaLab
Certificate of Analysis · continued
5-Amino-1MQ 50 mg/mL Pen · Lot PL-2610-004 · Certificate PL-26-00127
Lot PL-2610-004
Method, peak table and approval
2HPLC method · PL-2610-004-HPLC.raw
Instrument
Waters Alliance e2695
Data System
Empower 3
Detector
UV absorbance
Detection Wavelength
254–306 nm
Column
C18, 150 × 4.6 mm, 3.5 µm
Mobile Phase A
0.1% TFA in water
Mobile Phase B
0.1% TFA in MeCN
Gradient
5–95% B over 25 min (linear)
Flow Rate
1.0 mL/min
Column Temperature
40 °C
Injection Volume
10 µL
3Gradient program
Time (min)
% A
% B
0.0
95
5
25.0
5
95
4Peak table
Peak
RT (min)
Area
Area %
1
8.91 †
—
0.04
2
10.37
—
99.75
3
11.63 †
—
0.11
4
12.40 †
—
0.10
Total
—
100.00
Peaks: 1 related substance a; 2 main peak (5-Amino-1MQ); 3 related substance b; 4 related substance c · Area % from the integrated peak table (absolute areas are not part of the lot-release export) · † nominal reference RT for the assigned impurity · Purity = main peak area ÷ total integrated area × 100, to two decimals; main peak shaded.
5Identity by mass spectrometry
Instrument
Waters SQD
Ionization / Mode
ESI, positive
Reference m/z (ion)
159.09 [M]+
Deconvoluted Mass
159.10 Da
Theoretical Mass
159.09 Da (cation)
Difference
+0.01 Da (63 ppm)
Data File
PL-2610-004-MS.d
Acceptance
Within ± 1.0 Da
6Additional tests
Test
Performed by
Date
Report / file
Assay vs label claim
PrymaLab Analytical
2026-10-02
—
Endotoxin (LAL, kinetic)
PrymaLab Analytical
2026-10-02
—
Sterility (USP <71>, day-14 read-out)
PrymaLab Analytical
2026-10-16
—
A test with no row here was not performed on this lot. Outside-laboratory reports, when used, are attached and named below.
7Review and approval
D. Reynolds Analyst · performed the testing Date: 2026-10-16
S. Calloway Reviewer · checked against raw data Date: 2026-10-16
M. Phelps Lab Director · approved for release Date: 2026-10-16
