PrymaLab

PrymaLab Analytical · In-house laboratory

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

Certificate no.

PL-26-00300

Verification key

N8PD69W2

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

Certificate of Analysis · Lot release

Semax 10 mg Nasal Spray

Lot PL-2610-187 · Solution · Label claim 10 mg per bottle

Tested in-house by PrymaLab

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

Lot / batch number

PL-2610-187

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

251 / 2

Storage

—

Certificate type

Lot COA, 2 pages

Compound

Semax

ACTH(4–7)-Pro-Gly-Pro heptapeptide (MEHFPGP)

CAS number

80714-61-0

Molecular formula

C₃₇H₅₁N₉O₁₀S

Theoretical mass (avg.)

813.90 Da

Sequence

MEHFPGP

Purity · RP-HPLC, area %

99.60%

Specification ≥ 99.0% • main peak at 10.72 min

Identity · Observed Mass

813.88 Da

Theoretical 813.90 Da • −0.02 Da (25 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	813.88 Da	PASS
Purity	RP-HPLC, UV 214 nm, area%	≥ 99.0%	99.60%	PASS
Largest impurity	RP-HPLC, area%	≤ 1.0%	0.25% (RT 11.40)	PASS
Assay (label claim)	Assay vs label claim	9.5–10.5 mg/bottle	9.94 mg/bottle	PASS
Bacterial endotoxin	LAL, kinetic	≤ 5.0 EU/mg	0.261 EU/mg	PASS
Aerobic count (TAMC)	USP <61>	< 10 CFU/mL	< 10 CFU/mL	PASS
Yeast & mold (TYMC)	USP <61>	< 10 CFU/mL	< 10 CFU/mL	PASS
E. coli	USP <62>	Absent	Absent	PASS

1HPLC chromatogram

Data file: PL-2610-187-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-2610-187-HPLC.raw. † Nominal reference retention time for the assigned impurity; the main-peak RT is observed in this lot.

PrymaLab

Certificate of Analysis · continued

Semax 10 mg Nasal Spray · Lot PL-2610-187 · Certificate PL-26-00300

Lot PL-2610-187

Method, peak table and approval

2HPLC method · PL-2610-187-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	9.50 †	—	0.06
2	10.72	—	99.60
3	11.40 †	—	0.25
4	12.10 †	—	0.09
Total		—	100.00

Peaks: 1 methionine oxidation product; 2 main peak (Semax); 3 deamidation product; 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)

814.91 (M+H)+

Deconvoluted Mass

813.88 Da

Theoretical Mass

813.90 Da

Difference

−0.02 Da (25 ppm)

Data File

PL-2610-187-MS.d

Acceptance

Within ± 1.0 Da

6Additional tests

Test	Performed by	Date	Report / file
Assay vs label claim	PrymaLab Analytical	2026-10-08	—
Endotoxin (LAL, kinetic)	PrymaLab Analytical	2026-10-08	—
Microbial limits (USP <61>/<62>)	PrymaLab Analytical	2026-10-14	—

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