Certificate PL-26-00326 · Thymosin Beta-4 Frag Ac-SDKP 500 mcg Capsules (60 ct) · lot PL-2610-214
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PrymaLab
PrymaLab Analytical · In-house laboratory
3705 Music Branch Rd, Ashland, KY 41102 · +1 (606) 465-9063 · prymalab.net
Certificate no.
PL-26-00326
Verification key
MNQZ9FKW
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Certificate of Analysis · Lot release

Thymosin Beta-4 Frag Ac-SDKP 500 mcg Capsules (60 ct)

Lot PL-2610-214 · 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-2610-214
Date made
2026-10-07
Date of analysis
2026-10-08
Date issued
2026-10-15
Retest / expiry
2028-10-07
Units in lot / sampled
199 / 2
Storage
—
Certificate type
Lot COA, 2 pages
Compound
Ac-SDKP
Goralatide; N-acetyl-Ser-Asp-Lys-Pro (thymosin beta-4 fragment 1-4)
CAS number
127103-11-1
Molecular formula
C20H33N5O9
Theoretical mass (avg.)
487.51 Da
Sequence
Ac-SDKP
Purity · RP-HPLC, area %
99.65%
Specification ≥ 99.0% • main peak at 6.28 min
Identity · Observed Mass
487.48 Da
Theoretical 487.51 Da • −0.03 Da (62 ppm)
Overall conclusion
PASS
Meets every specification for the tests performed
TestMethodSpecificationResultConclusion
Identity (mass)LC-MS, ESI positiveTheoretical ± 1.0 Da487.48 DaPASS
PurityRP-HPLC, UV 214 nm, area%≥ 99.0%99.65%PASS
Largest impurityRP-HPLC, area%≤ 1.0%0.23% (RT 7.70)PASS
Capsule contentContent vs label claim0.45–0.55 mg/cap0.49 mg/capPASS
Bacterial endotoxinLAL, kinetic——N/A
Aerobic count (TAMC)USP <61>< 10 CFU/g< 10 CFU/gPASS
Yeast & mold (TYMC)USP <61>< 10 CFU/g< 10 CFU/gPASS
E. coliUSP <62>AbsentAbsentPASS

1HPLC chromatogram

Data file: PL-2610-214-HPLC.raw · Column C18, 150 × 4.6 mm · UV 214 nm
0.01%0.1%1%10%100%456789Retention time (min) · stick height = area % (log scale)99.65% · 6.28 min0.08% †0.04% †0.23% †
Peak plot drawn from the integrated peak table (area %, log scale); it is not the instrument trace, which is retained in PL-2610-214-HPLC.raw. † Nominal reference retention time for the assigned impurity; the main-peak RT is observed in this lot.
PrymaLab
PrymaLab
Certificate of Analysis · continued
Thymosin Beta-4 Frag Ac-SDKP 500 mcg Capsules (60 ct) · Lot PL-2610-214 · Certificate PL-26-00326
Lot PL-2610-214
Method, peak table and approval

2HPLC method · PL-2610-214-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
0.0955
25.0595

4Peak table

PeakRT (min)AreaArea %
15.30 †—0.08
26.28—99.65
37.10 †—0.04
47.70 †—0.23
Total—100.00
Peaks: 1 unidentified impurity; 2 main peak (Ac-SDKP); 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 (charge)
488.52 (M+H)+
Deconvoluted Mass
487.48 Da
Theoretical Mass
487.51 Da
Difference
−0.03 Da (62 ppm)
Data File
PL-2610-214-MS.d
Acceptance
Within ± 1.0 Da

6Additional tests

TestPerformed byDateReport / file
Content vs label claimPrymaLab Analytical2026-10-08—
Microbial limits (USP <61>/<62>)PrymaLab Analytical2026-10-14—
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