PrymaLab

PrymaLab Analytical · In-house laboratory

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

Certificate no.

PL-26-00078

Verification key

PLDRCP4N

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

Certificate of Analysis · Lot release

PNC-27 10 mg

Lot PL-2609-078 · 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-2609-078

Date made

2026-09-15

Date of analysis

2026-09-17

Date issued

2026-10-03

Retest / expiry

2028-09-15

Units in lot / sampled

250 / 2

Storage

−20 °C, desiccated, dark

Certificate type

Lot COA, 2 pages

Compound

PNC-27

p53(12–26) fused to a membrane-residency peptide

CAS number

1159861-00-3

Molecular formula

C₁₈₈H₂₉₃N₅₃O₄₄S

Theoretical mass (avg.)

4031.7 Da

Sequence

H-PPLSQETFSDLWKLLKKWKMRRNQFWVKVQRG-OH (32 residues; p53 residues 12–26 followed by the membrane-residency peptide; free N- and C-termini)

Purity · RP-HPLC, area %

99.57%

Specification 99.0% • main peak at 7.24 min

Identity · Observed Mass

4,032.1 Da

Theoretical 4,031.7 Da • +0.4 Da (99 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	4,032.1 Da ([M+4H] 4+ 1009.0 · [M+5H] 5+ 807.4)	PASS
Purity	RP-HPLC, UV 214 nm, area%	99.0%	99.57%	PASS
Largest impurity	RP-HPLC, area%	1.0%	0.18% at 8.16 min	PASS
Water content	Karl Fischer	5.0%	2.3%	PASS
Bacterial endotoxin	LAL, kinetic	≤ 5.0 EU/mg	0.09 EU/mg	PASS
Sterility / bioburden	USP <71>, membrane filtration	No growth after 14 days	No growth; conforms	PASS

1HPLC chromatogram

Data file: PNC27_PL-2609-078_20260917_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

PNC-27 10 mg · Lot PL-2609-078 · Certificate PL-26-00078

Lot PL-2609-078

Method, peak table and approval

2HPLC method · PNC27_PL-2609-078_20260917_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

12 min

Sample Diluent

Water, 0.1% TFA

Sample Concentration

0.5 mg/mL

Blank Injected

Yes

Reference Standard

In-house PNC-27 reference, lot PL-RS-PNC27-01, RT 7.23 min

3Gradient program

Time (min)	% A	% B
0.0	95	5
2.0	95	5
8.0	55	45
9.5	20	80
10.5	20	80
12.0	95	5

4Peak table

Peak	RT (min)	Area	Area %
1	5.31	6,800	0.16
2	7.24	4,231,725	99.57
3	8.16	7,650	0.18
4	8.80	3,825	0.09
Total		4,250,000	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)

1009.0 (4+ [M+4H]) · 807.4 (5+ [M+5H])

Deconvoluted Mass

4,032.1 Da

Theoretical Mass

4,031.7 Da

Difference

+0.4 Da (99 ppm)

Data File

PNC27_PL-2609-078_MS_20260917_01

Acceptance

Within ± 1.0 Da

6Additional tests

Test	Performed by	Date	Report / file
Water content	PrymaLab	2026-09-18	RPT-KF-PL-2609-078
Endotoxin	PrymaLab	2026-09-19	RPT-ET-PL-2609-078
Sterility	PrymaLab	2026-10-01	RPT-ST-PL-2609-078

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: 2026-09-17

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

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