PrymaLab

PrymaLab Analytical · In-house laboratory

3705 Music Branch Rd, Ashland, KY 41102 · +1 (606) 465-9063 · prymalab.net

Certificate no.

PL-26-00107

Verification key

NNYW5GZG

Scan or enter both at
prymalab.net/testing/verify

Certificate of Analysis · Lot release

Thymosin Alpha-1 10 mg

Lot PL-2609-107 · Lyophilized powder · Label claim 10 mg/vial

Tested in-house by PrymaLab

In-house analytical result,
not an independent third-party test

Lot / batch number

PL-2609-107

Date made

2026-09-18

Date of analysis

2026-09-19

Date issued

2026-10-03

Retest / expiry

2028-09-18

Units in lot / sampled

250 / 2

Storage

−20 °C, desiccated, dark

Certificate type

Lot COA, 2 pages

Compound

Thymosin Alpha-1

Thymalfasin; Tα1

CAS number

62304-98-7

Molecular formula

C₁₂₉H₂₁₅N₃₃O₅₅

Theoretical mass (avg.)

3108.3 Da

Sequence

Ac-SDAAVDTSSEITTKDLKEKKEVVEEAEN-OH (28 residues; N-acetyl; free C-terminus)

Purity · RP-HPLC, area %

99.35%

Specification 99.0% • main peak at 3.42 min

Identity · Observed Mass

3108.5 Da

Theoretical 3108.3 Da • +0.2 Da (64 ppm)

Overall conclusion

PASS

Meets every specification for the tests performed

Test	Method	Specification	Result	Conclusion
Appearance	Visual inspection	White to off-white lyophilized powder	White lyophilized powder	PASS
Identity (mass)	LC-MS, ESI positive	Theoretical ± 1.0 Da	3108.5 Da	PASS
Purity	RP-HPLC, UV 214 nm, area%	99.0%	99.35%	PASS
Largest impurity	RP-HPLC, area%	1.0%	0.32% at 4.16 min (des-acetyl species)	PASS
Water content	Karl Fischer	5.0%	1.9%	PASS
Bacterial endotoxin	LAL, kinetic	≤ 5.0 EU/mg	0.06 EU/mg	PASS
Sterility / bioburden	USP <71>, membrane filtration	No growth after 14 days	No growth; conforms	PASS

1HPLC chromatogram

Data file: TA1_PL-2609-107_20260919_01 · Column C18, 150 × 4.6 mm · UV 214 nm

Baseline uncropped; main peak and impurities labeled with retention times. Peak table on page 2.

PrymaLab

Certificate of Analysis · continued

Thymosin Alpha-1 10 mg · Lot PL-2609-107 · Certificate PL-26-00107

Lot PL-2609-107

Method, peak table and approval

2HPLC method · TA1_PL-2609-107_20260919_01

Instrument

Waters Alliance e2695, SN E2695B742

Data System

Empower 3, Build 3471

Detector

Waters 2998 PDA

Detection Wavelength

214 nm

Column

C18, 150 × 4.6 mm, 3.5 µm

Column Part / Serial

186003326 / USHX18211

Mobile Phase A

0.1% TFA in water

Mobile Phase B

0.1% TFA in MeCN

Flow Rate

1.0 mL/min

Column Temperature

30 °C

Injection Volume

20 µL

Run Time

10 min

Sample Diluent

Water, 0.1% TFA

Sample Concentration

0.5 mg/mL

Blank Injected

Yes

Reference Standard

In-house Thymosin Alpha-1 reference, lot PL-RS-TA1-01, RT 3.40 min

3Gradient program

Time (min)	% A	% B
0.0	95	5
3.0	95	5
7.0	55	45
8.0	20	80
9.0	20	80
10.0	95	5

4Peak table

Peak	RT (min)	Area	Area %
1	2.74	6,450	0.15
2	3.42	4,272,050	99.35
3 (des-acetyl)	4.16	13,760	0.32
4	4.88	7,740	0.18
Total		4,300,000	100.00

Threshold 0.05% area · Blank subtracted: Y · Purity = main peak area ÷ total integrated area × 100, to two decimals; main peak shaded.

5Identity by mass spectrometry

Instrument

Waters Acquity SQD

Ionization / Mode

ESI, positive

Observed m/z (charge)

1037.2 (3+ [M+3H]) · 778.1 (4+ [M+4H])

Deconvoluted Mass

3108.5 Da

Theoretical Mass

3108.3 Da (N-acetylated 28-mer)

Difference

+0.2 Da (64 ppm)

Data File

TA1_PL-2609-107_MS_20260919_01

Acceptance

Within ± 1.0 Da

6Additional tests

Test	Performed by	Date	Report / file
Water content	PrymaLab	2026-09-20	RPT-KF-PL-2609-107
Endotoxin	PrymaLab	2026-09-21	RPT-ET-PL-2609-107
Sterility	PrymaLab	2026-10-02	RPT-ST-PL-2609-107

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: 2026-09-19

S. Calloway
Reviewer · checked against raw data
Date: 2026-10-02

M. Phelps
Lab Director · approved for release
Date: 2026-10-03