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Certificate no.
PL-26-00071
Verification key
2QV2T32Q
Scan or enter both at prymalab.net/testing/verify
Certificate of Analysis · Lot release
P21 (P021) 5 mg
Lot PL-2609-071 · Lyophilized powder · Label claim 5 mg/vial
Tested in-house by PrymaLab
In-house analytical result, not an independent third-party test
Lot / batch number
PL-2609-071
Date made
2026-09-05
Date of analysis
2026-09-08
Date issued
2026-10-03
Retest / expiry
2028-09-05
Units in lot / sampled
250 / 2
Storage
−20 °C, desiccated, dark
Certificate type
Lot COA, 2 pages
Compound
P21 (P021)
Ac-DGGL coupled to 3-aminoadamantane-1-carboxamide; CNTF-derived peptidomimetic
CAS number
1246751-68-7
Molecular formula
C27H42N6O8
Theoretical mass (avg.)
578.7 Da
Sequence
Ac-DGGL-NH-(3-carbamoyladamantan-1-yl): the tetrapeptide Ac-Asp-Gly-Gly-Leu amidated at its C-terminus with 3-aminoadamantane-1-carboxamide; N-acetyl; no disulfides.
Purity · RP-HPLC, area %
99.52%
Specification 99.0% • main peak at 5.85 min
Identity · Observed Mass
578.8 Da
Theoretical 578.7 Da • +0.1 Da (173 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
578.8 Da
PASS
Purity
RP-HPLC, UV 214 nm, area%
99.0%
99.52%
PASS
Largest impurity
RP-HPLC, area%
1.0%
0.18% at 6.61 min
PASS
Water content
Karl Fischer
5.0%
1.7%
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: P21_PL-2609-071_20260908_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
P21 (P021) 5 mg · Lot PL-2609-071 · Certificate PL-26-00071
Lot PL-2609-071
Method, peak table and approval
2HPLC method · P21_PL-2609-071_20260908_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 P21 reference, lot PL-RS-P21-01, RT 5.81 min
3Gradient program
Time (min)
% A
% B
0.0
95
5
2.0
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
4.41
7,808
0.16
2
5.85
4,856,576
99.52
3
6.61
8,784
0.18
4
7.22
6,832
0.14
Total
4,880,000
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)
579.8 (1+ [M+H]) · 601.7 (1+ [M+Na])
Deconvoluted Mass
578.8 Da
Theoretical Mass
578.7 Da
Difference
+0.1 Da (173 ppm)
Data File
P21_PL-2609-071_MS_20260908_01
Acceptance
Within ± 1.0 Da
6Additional tests
Test
Performed by
Date
Report / file
Water content
PrymaLab
2026-09-09
RPT-KF-PL-2609-071
Endotoxin
PrymaLab
2026-09-10
RPT-ET-PL-2609-071
Sterility
PrymaLab
2026-09-22
RPT-ST-PL-2609-071
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: 2026-09-08
S. Calloway Reviewer · checked against raw data Date: 2026-10-02
M. Phelps Lab Director · approved for release Date: 2026-10-03
