Data file: PL-2610-059-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-2610-059-HPLC.raw. † Nominal reference retention time for the assigned impurity; the main-peak RT is observed in this lot.
Peaks: 1 deamidation product; 2 main peak (Epitalon); 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)
391.36 (M+H)+
Deconvoluted Mass
390.38 Da
Theoretical Mass
390.35 Da
Difference
+0.03 Da (77 ppm)
Data File
PL-2610-059-MS.d
Acceptance
Within ± 1.0 Da
6Additional tests
Test
Performed by
Date
Report / file
Assay vs label claim
PrymaLab Analytical
2026-10-05
—
Endotoxin (LAL, kinetic)
PrymaLab Analytical
2026-10-05
—
Microbial limits (USP <61>/<62>)
PrymaLab Analytical
2026-10-12
—
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: 2026-10-12
S. Calloway Reviewer · checked against raw data Date: 2026-10-12
M. Phelps Lab Director · approved for release Date: 2026-10-12