Certificate PL-26-00162 · Cerebrolysin 60 mg · lot PL-2610-040
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PrymaLab
PrymaLab
PrymaLab Analytical · In-house laboratory
3705 Music Branch Rd, Ashland, KY 41102 · +1 (606) 465-9063 · prymalab.net
Certificate no.
PL-26-00162
Verification key
HDD2KLXA
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Certificate of Analysis · Lot release

Cerebrolysin 60 mg

Lot PL-2610-040 · Lyophilized powder · Label claim 60 mg per vial
Tested in-house by PrymaLab
In-house analytical result,
not an independent third-party test
Lot / batch number
PL-2610-040
Date made
2026-10-01
Date of analysis
2026-10-02
Date issued
2026-10-16
Retest / expiry
2028-10-01
Units in lot / sampled
295 / 2
Storage
2–8 °C, dark
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 %
99.60%
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
TestMethodSpecificationResultConclusion
Identity (peptide map)LC-MS peptide mapMatches referenceMatches referencePASS
Purity (main band)RP-HPLC, UV 214 nm, area%≥ 99.0%99.60%PASS
Water contentKarl Fischer≤ 5.0%2.80%PASS
Bacterial endotoxinLAL, kinetic≤ 5.0 EU/mg0.222 EU/mgPASS
SterilityUSP <71>, 14-dayNo growthNo growthPASS

1HPLC chromatogram

Data file: PL-2610-040-HPLC.raw · Column C18, 150 × 4.6 mm · UV 214 nm
Complex peptide mixture: main-band purity reported as area %; see page 2.
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-2610-040-HPLC.raw.
PrymaLab
PrymaLab
Certificate of Analysis · continued
Cerebrolysin 60 mg · Lot PL-2610-040 · Certificate PL-26-00162
Lot PL-2610-040
Method, peak table and approval

2HPLC method · PL-2610-040-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
0.0955
25.0595

4Peak table

PeakRT (min)AreaArea %
1——99.60
2——0.40
Total—100.00
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-2610-040-MS.d

6Additional tests

TestPerformed byDateReport / file
Water content (Karl Fischer)PrymaLab Analytical2026-10-02—
Endotoxin (LAL, kinetic)PrymaLab Analytical2026-10-02—
Sterility (USP <71>, day-14 read-out)PrymaLab Analytical2026-10-16—
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: 2026-10-16
S. Calloway
Reviewer · checked against raw data
Date: 2026-10-16
M. Phelps
Lab Director · approved for release
Date: 2026-10-16