PrymaLab

PrymaLab Analytical · In-house laboratory

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

Certificate no.

PL-26-00204

Verification key

YA3EE4DE

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

Certificate of Analysis · Lot release

Glutathione 250 mg Nasal Spray

Lot PL-2610-086 · Solution · Label claim 250 mg per bottle

Tested in-house by PrymaLab

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

Lot / batch number

PL-2610-086

Date made

2026-10-02

Date of analysis

2026-10-05

Date issued

2026-10-12

Retest / expiry

2028-10-02

Units in lot / sampled

384 / 2

Storage

—

Certificate type

Lot COA, 2 pages

Compound

Glutathione

GSH; γ-L-glutamyl-L-cysteinyl-glycine

CAS number

70-18-8

Molecular formula

C₁₀H₁₇N₃O₆S

Theoretical mass (avg.)

307.32 Da

Sequence

gamma-ECG

Purity · RP-HPLC, area %

99.51%

Specification ≥ 99.0% • main peak at 4.80 min

Identity · Observed Mass

307.31 Da

Theoretical 307.32 Da • −0.01 Da (33 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	307.31 Da	PASS
Purity	RP-HPLC, UV 214 nm, area%	≥ 99.0%	99.51%	PASS
Largest impurity	RP-HPLC, area%	≤ 1.0%	0.27% (RT 5.60)	PASS
Assay (label claim)	Assay vs label claim	237.5–262.5 mg/bottle	247.53 mg/bottle	PASS
Bacterial endotoxin	LAL, kinetic	≤ 5.0 EU/mg	0.283 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-2610-086-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-2610-086-HPLC.raw. † Nominal reference retention time for the assigned impurity; the main-peak RT is observed in this lot.

PrymaLab

Certificate of Analysis · continued

Glutathione 250 mg Nasal Spray · Lot PL-2610-086 · Certificate PL-26-00204

Lot PL-2610-086

Method, peak table and approval

2HPLC method · PL-2610-086-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	3.90 †	—	0.08
2	4.80	—	99.51
3	5.60 †	—	0.27
4	6.20 †	—	0.14
Total		—	100.00

Peaks: 1 oxidized glutathione (gssg); 2 main peak (Glutathione); 3 deamidation product; 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)

308.33 (M+H)+

Deconvoluted Mass

307.31 Da

Theoretical Mass

307.32 Da

Difference

−0.01 Da (33 ppm)

Data File

PL-2610-086-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