3705 Music Branch Rd, Ashland, KY 41102 · +1 (606) 465-9063 · prymalab.net
Certificate no.
PL-26-00020
Verification key
YYVP93ES
Scan or enter both at prymalab.net/testing/verify
Certificate of Analysis · Lot release
Cerebrolysin 60 mg
Lot PL-2609-020 · Lyophilized powder · Label claim 60 mg/vial
Tested in-house by PrymaLab
In-house analytical result, not an independent third-party test
Lot / batch number
PL-2609-020
Date made
2026-09-18
Date of analysis
2026-09-19
Date issued
2026-10-03
Retest / expiry
2028-09-18
Units in lot / sampled
250 / 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.)
Peptide fraction below 10 kDa (mostly 1–5 kDa) plus free L-amino acids (about 75% of nitrogen)
Structure
Standardised enzymatic hydrolysate of purified porcine brain proteins: low-molecular-weight peptides plus free L-amino acids. No single sequence; identity is established by LC-MS peptide mapping against the in-house reference.
Purity · RP-HPLC, area %
99.7%
Specification 99.0% • dominant peptide fraction at 3.84 min
Identity · LC-MS Profile
Confirmed
638+ peptide peaks mapped vs in-house reference; tubulin/actin/MBP-derived
Data file: CRB_PL-2609-020_20260919_01 · Column C18, 150 × 4.6 mm · UV 214 nm
Baseline uncropped; dominant peptide-fraction cluster and minor impurity labeled. Peak table on page 2.
PrymaLab
Certificate of Analysis · continued
Cerebrolysin 60 mg · Lot PL-2609-020 · Certificate PL-26-00020
Lot PL-2609-020
Method, peak table and approval
2HPLC method · CRB_PL-2609-020_20260919_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 (pooled composite)
Blank Injected
Yes
Reference Standard
In-house Cerebrolysin reference (peptide-map), lot PL-RS-CRB-01, dominant cluster RT 3.82 min
3Gradient program
Time (min)
% A
% B
0.0
95
5
3.0
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 (peptide flicker 2.4–3.2)
2.4–3.2 env.
8,600
0.20
2 (peptide flicker 2.8–3.8)
2.8–3.8 env.
3,440
0.08
3 (dominant cluster)
3.84
4,284,890
99.7
4
4.56
6,070
0.14
Total
4,303,000
100.00
Threshold 0.05% area · Blank subtracted: Y · Mixture — dominant cluster shaded; minor peptide-fraction peaks co-resolved · 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
Peptides Mapped
638+ unique species
Source Proteins
Tubulin α/β-chain · Actin · Myelin basic protein
MW Distribution
<10 kDa peptide fraction (majority 1–5 kDa)
Amino-Acid Fraction
~75% of nitrogen content (free L-AAs)
Data File
CRB_PL-2609-020_MS_20260919_01
Acceptance
Peptide map matches reference profile
6Additional tests
Test
Performed by
Date
Report / file
Water content
PrymaLab
2026-09-20
RPT-KF-PL-2609-020
Endotoxin
PrymaLab
2026-09-21
RPT-ET-PL-2609-020
Sterility
PrymaLab
2026-10-02
RPT-ST-PL-2609-020
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: 2026-09-19
S. Calloway Reviewer · checked against raw data Date: 2026-10-02
M. Phelps Lab Director · approved for release Date: 2026-10-03
