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Certificate no.
PL-26-00163
Verification key
HEYA6D7J
Scan or enter both at prymalab.net/testing/verify
Certificate of Analysis · Lot release
Cerebrolysin 120 mg Nasal Spray
Lot PL-2610-041 · Solution · Label claim
Tested in-house by PrymaLab
In-house analytical result, not an independent third-party test
Lot / batch number
PL-2610-041
Date made
2026-10-01
Date of analysis
2026-10-02
Date issued
2026-10-09
Retest / expiry
2028-10-01
Units in lot / sampled
278 / 2
Storage
—
Certificate type
Lot COA, 2 pages
Compound
Cerebrolysin
Porcine brain peptide hydrolysate; a peptide preparation, not a single compound
CAS number
12656-61-0
Molecular formula
Not applicable (mixture)
Theoretical mass (avg.)
n/a (complex peptide mixture)
Structure
porcine brain peptide complex <10 kDa
Purity · RP-HPLC, area %
99.40%
Specification ≥ 99.0% • area % of the main RP-HPLC band
Identity · Peptide Map
Match
LC-MS peptide map matches the reference
Overall conclusion
PASS
Meets every specification for the tests performed
Test
Method
Specification
Result
Conclusion
Identity (peptide map)
LC-MS peptide map
Matches reference
Matches reference
PASS
Purity (main band)
RP-HPLC, UV 214 nm, area%
≥ 99.0%
99.40%
PASS
Water content
Karl Fischer
≤ 5.0%
3.18%
PASS
Bacterial endotoxin
LAL, kinetic
≤ 5.0 EU/mg
0.203 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-2610-041-HPLC.raw · Column C18, 150 × 4.6 mm · UV 214 nm
Main-band purity as recorded in the lot-release data (complex peptide mixture; individual bands are not assigned and no retention times were exported, so no peak plot is drawn). Instrument data retained in PL-2610-041-HPLC.raw.
Peaks: 1 main band; 2 all other bands (by difference) · main-band area % from the lot-release data · 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
Method
LC-MS peptide map vs reference
Result
Peptide map matches reference
Data File
PL-2610-041-MS.d
6Additional tests
Test
Performed by
Date
Report / file
Water content (Karl Fischer)
PrymaLab Analytical
2026-10-02
—
Endotoxin (LAL, kinetic)
PrymaLab Analytical
2026-10-02
—
Microbial limits (USP <61>/<62>)
PrymaLab Analytical
2026-10-08
—
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: 2026-10-09
S. Calloway Reviewer · checked against raw data Date: 2026-10-09
M. Phelps Lab Director · approved for release Date: 2026-10-09