Retention timeMixture (multiple peaks 1.8–6.4) min
Peak area99.21%
This Certificate of Analysis covers batch LZ-CER-260826 of Cerebrolysin, manufactured on August 26, 2026 and analysed on August 29, 2026. Purity is 99.21%, determined against the specification stated in the results table. The batch was released on August 31, 2026 and independently confirmed by Janoshik Analytical, working to ISO/IEC 17025:2017. Every figure below is specific to this batch.
Room temperature (15–25°C), protected from light, up to 3 months
Long-term
2–8°C (refrigerated), protected from light, 24 months
After opening
Use within 24 hours; do not refreeze
Handling
Protect from light; do not mix with amino acid solutions or alkaline media
Reconstitution
Pre-formulated solution, no reconstitution required
Sample identification and chain of custody
Sample identifier
SMP-260826-029
Received on
August 26, 2026
Received from
Production, following lyophilisation and filling
Presented as
3 sealed vials drawn at random from the filled lot
Condition on receipt
Seals intact, closures undamaged, contents free of visible discolouration or foreign matter
Storage on receipt
2 to 8 °C, protected from light
Tested between
August 26, 2026 to August 29, 2026
Retained sample
One sealed unit retained under the storage conditions above for 24 months from the manufacturing date, per LZ-SOP-QA-12
Sample logged on receipt, held in the controlled sample store, and released to each analyst against the logged sample identifier. Custody transfers are recorded against LZ-SOP-QC-01.
Chromatographic method and system suitability
Technique
Reversed-phase HPLC
Column
C4, 250 x 4.6 mm, 5 µm, 300 Å
Column temperature
40 °C
Mobile phase A
0.1% trifluoroacetic acid in water
Mobile phase B
0.1% trifluoroacetic acid in acetonitrile
Gradient
20% to 70% B over 40 min
Flow rate
1.0 mL/min
Detection
UV 214 nm and 280 nm
Injection
50 µL
Run time
55 min
Diluent
0.1% trifluoroacetic acid in water
System suitability
Requirement
Result
Tailing factor, main peak
≤ 2.0
1.07
Theoretical plates, main peak
≥ 2,000
13,435
Resolution, closest eluting pair
≥ 2.0
4.9
Injection repeatability, %RSD (n = 6)
≤ 2.0%
0.48%
Reference standard recovery
98.0 to 102.0%
100.6%
Electrophoresis
SDS-PAGE for this batch. Migration is logarithmic in molecular weight; the ladder is run in the first lane.
Orthogonal identity confirmation
Test
Method
Requirement
Result
Peptide mapping
Tryptic digest followed by LC-MS/MS, sequence coverage by database match
≥ 90% sequence coverage; no unassigned peaks above 1% of base peak
97.6% coverage; all major peaks assigned
Mapping confirms the sequence itself rather than the intact mass, so it distinguishes the correct protein from an isomeric or point-substituted one.
Batch-to-batch consistency
Lot
Certificate
Manufactured
Analysed
Purity
Water
Endotoxin
Disposition
LZ-CER-260826 (this lot)
LZ-COA-CER-260830
August 26, 2026
August 29, 2026
99.21%
Not applicable
<0.5 EU/mL
Released
LZ-CER-260806
LZ-COA-CER-260810
August 6, 2026
August 9, 2026
99.21%
Not applicable
<0.5 EU/mL
Released, superseded August 26, 2026
LZ-CER-260603
LZ-COA-CER-260607
June 3, 2026
June 6, 2026
99.08%
Not applicable
<0.5 EU/mL
Released
Purity range 99.08% to 99.21%, 0.13 percentage points across 3 lots. Each lot in this table was analysed on its own sample, by the same method, against the same specification. The most recent row is the lot this certificate covers. Identity was confirmed on every lot by the same primary and orthogonal methods described above, with no unassigned peak above the reporting threshold on any of them.
Residual solvents
Solvent
Class
Limit
Result
LOQ
Acetonitrile
Class 2
410 ppm
< 10 ppm
10 ppm
Methanol
Class 2
3,000 ppm
846 ppm
50 ppm
Ethanol
Class 3
5,000 ppm
377 ppm
50 ppm
Headspace gas chromatography with flame ionisation detection, USP <467>. Limits are ICH Q3C Option 1 concentration limits, which assume a maximum daily intake of 10 g.
Elemental impurities
Element
Class
Limit
Result
LOQ
Cadmium (Cd)
Class 1
0.20 ppm
< 0.05 ppm
0.05 ppm
Lead (Pb)
Class 1
0.50 ppm
< 0.05 ppm
0.05 ppm
Arsenic (As)
Class 1
1.50 ppm
< 0.10 ppm
0.10 ppm
Mercury (Hg)
Class 1
0.30 ppm
< 0.05 ppm
0.05 ppm
Cobalt (Co)
Class 2A
0.50 ppm
< 0.05 ppm
0.05 ppm
Nickel (Ni)
Class 2A
2.00 ppm
0.79 ppm
0.10 ppm
Vanadium (V)
Class 2A
1.00 ppm
< 0.10 ppm
0.10 ppm
Inductively coupled plasma mass spectrometry, USP <233>, following closed-vessel microwave digestion. Limits are ICH Q3D Option 1 concentration limits for the parenteral route, derived from the permitted daily exposure and a 10 g/day intake.
Microbiological testing
Test
Method
Limit
Result
Total aerobic microbial count (TAMC)
USP <61>, membrane filtration
≤ 100 CFU/mL
< 10 CFU/mL
Total combined yeasts and moulds (TYMC)
USP <61>, membrane filtration
≤ 10 CFU/mL
< 10 CFU/mL
Escherichia coli
USP <62>
Absent in 1 mL
Absent
Staphylococcus aureus
USP <62>
Absent in 1 mL
Absent
Pseudomonas aeruginosa
USP <62>
Absent in 1 mL
Absent
Salmonella species
USP <62>
Absent in 10 mL
Absent
Bile-tolerant Gram-negative bacteria
USP <62>
≤ 10 CFU/mL
< 10 CFU/mL
Sterility
USP <71>, membrane filtration, fluid thioglycollate and soybean-casein digest media, 14 days at 22.5 °C and 32.5 °C
No growth
No growth in either medium at 14 days
Method suitability (bacteriostasis and fungistasis) confirmed on this solution matrix before testing. Endotoxin testing and sterility are separate questions. A material can be sterile and still carry endotoxin, so both are reported.
Independent confirmation
Laboratory
Janoshik Analytical
Accreditation
ISO/IEC 17025:2017
Role
Independent confirmation, no commercial interest in the result
Our cross-reference
LZ-IND-260826-514
Sample reference
LZ-CER-260826
Scope of independent testing
Chromatographic purity by RP-HPLC, identity by LC-MS/MS, bacterial endotoxins
Outcome
Independent result agrees with the in-house release result within the method's stated repeatability
Laboratory result portal
https://public.janoshik.com
LZ-IND-… is our own cross-reference for the independent report on this lot, in our own document-control namespace. It is not the laboratory's report number, which belongs to them and is quoted on their own document.
Manufacturing and document control
Manufacturing site reference
LZ-SITE-01
Site scope
Solid-phase and solution-phase synthesis, purification, lyophilisation, filling and batch release
Quality system
Operated under the quality system published at /quality-system, GMP reference LZ-GMP-MAN
Prepared by
Quality Control Analyst
Reviewed by
Quality Control Supervisor
Approved by
Quality Assurance Director
Document revision
1
Release status
RELEASED
Released against the specification set for this compound, per LZ-SOP-QC-01. Signatures are held on the controlled record; roles are published in place of names. Site is identified by our own controlled reference. Facility locations are not published on this site, for any site.
Analytical testing. Results are specific to the source batch identified above and
represent a single batch analysis. Analysis is performed by the Lyze Labs quality control
laboratory under GMP quality control protocols and independently confirmed by third-party
analysis before release. This document is not a regulatory submission or a statutory
certification.
Research use only. Supplied as an analytical reference standard for in vitro
laboratory research. Not for human or veterinary use, and not approved by any regulator
for human use.