Data file: PL-2610-039-HPLC.raw · Column C18, 150 × 4.6 mm · UV 214 nm
Peak plot drawn from the integrated peak table (area %, log scale); it is not the instrument trace, which is retained in PL-2610-039-HPLC.raw. † Nominal reference retention time for the assigned impurity; the main-peak RT is observed in this lot.
PrymaLab
Certificate of Analysis · continued
Cartalax 20 mg Pen · Lot PL-2610-039 · Certificate PL-26-00161
Lot PL-2610-039
Method, peak table and approval
2HPLC method · PL-2610-039-HPLC.raw
Instrument
Waters Alliance e2695
Data System
Empower 3
Detector
UV absorbance
Detection Wavelength
214 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
9.20 †
—
0.05
2
10.50
—
99.54
3
11.40 †
—
0.21
4
12.00 †
—
0.20
Total
—
100.00
Peaks: 1 deamidation product; 2 main peak (Cartalax); 3 isoaspartate (isoasp) variant; 4 truncated sequence · 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 (charge)
334.31 (M+H)+
Deconvoluted Mass
333.28 Da
Theoretical Mass
333.30 Da
Difference
−0.02 Da (60 ppm)
Data File
PL-2610-039-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
