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Certificate no.
PL-26-00317
Verification key
ERXVXMDU
Scan or enter both at prymalab.net/testing/verify
Certificate of Analysis · Lot release
Tesofensine 500 mcg Capsules (30 ct)
Lot PL-2610-204 · Capsules · Label claim 500 mcg per capsule
Tested in-house by PrymaLab
In-house analytical result, not an independent third-party test
Lot / batch number
PL-2610-204
Date made
2026-10-07
Date of analysis
2026-10-09
Date issued
2026-10-15
Retest / expiry
2028-10-07
Units in lot / sampled
239 / 2
Storage
—
Certificate type
Lot COA, 2 pages
Compound
Tesofensine
Tesofensine (NS-2330), phenyltropane; small molecule
CAS number
195875-84-4
Molecular formula
C17H23Cl2NO
Theoretical mass (avg.)
328.28 Da
Structure
Purity · RP-HPLC, area %
99.61%
Specification ≥ 99.0% • main peak at 8.38 min
Identity · Observed Mass
328.26 Da
Theoretical 328.28 Da • −0.02 Da (61 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
328.26 Da
PASS
Purity
RP-HPLC, UV 254–306 nm, area%
≥ 99.0%
99.61%
PASS
Largest impurity
RP-HPLC, area%
≤ 1.0%
0.19% (RT 9.90)
PASS
Capsule content
Content vs label claim
0.45–0.55 mg/cap
0.50 mg/cap
PASS
Bacterial endotoxin
LAL, kinetic
—
—
N/A
Aerobic count (TAMC)
USP <61>
< 10 CFU/g
< 10 CFU/g
PASS
Yeast & mold (TYMC)
USP <61>
< 10 CFU/g
< 10 CFU/g
PASS
E. coli
USP <62>
Absent
Absent
PASS
1HPLC chromatogram
Data file: PL-2610-204-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-2610-204-HPLC.raw. † Nominal reference retention time for the assigned impurity; the main-peak RT is observed in this lot.
PrymaLab
Certificate of Analysis · continued
Tesofensine 500 mcg Capsules (30 ct) · Lot PL-2610-204 · Certificate PL-26-00317
Lot PL-2610-204
Method, peak table and approval
2HPLC method · PL-2610-204-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
7.40 †
—
0.12
2
8.38
—
99.61
3
9.20 †
—
0.08
4
9.90 †
—
0.19
Total
—
100.00
Peaks: 1 unidentified impurity; 2 main peak (Tesofensine); 3 unidentified impurity; 4 unidentified impurity · 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)
329.29 [M+H]+
Deconvoluted Mass
328.26 Da
Theoretical Mass
328.28 Da
Difference
−0.02 Da (61 ppm)
Data File
PL-2610-204-MS.d
Acceptance
Within ± 1.0 Da
6Additional tests
Test
Performed by
Date
Report / file
Content vs label claim
PrymaLab Analytical
2026-10-09
—
Microbial limits (USP <61>/<62>)
PrymaLab Analytical
2026-10-15
—
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: 2026-10-15
S. Calloway Reviewer · checked against raw data Date: 2026-10-15
M. Phelps Lab Director · approved for release Date: 2026-10-15
