Cerebrolysin Nasal Spray certificate of analysis, lot PL-2610-041
Certificate PL-26-00163 reports the release tests for Cerebrolysin Nasal Spray lot PL-2610-041: 99.40% purity by reverse-phase HPLC and identity confirmed by LC-MS, tested October 2, 2026. The lot number printed on each unit matches this certificate.
| Certificate number | PL-26-00163 |
|---|---|
| Lot number | PL-2610-041 |
| Compound | Cerebrolysin Nasal Spray 120 mg |
| Sequence | 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. |
| Molecular formula | Not applicable (mixture) |
| CAS number | 12656-61-0 |
| Purity (RP-HPLC) | 99.40% |
| Identity (LC-MS) | Conforms (Match) |
| Method | RP-HPLC (UV 214 nm) + LC-MS |
| Tested | October 2, 2026 |
| Retest by | October 1, 2028 |
| Tested by | Manufacturer’s in-house laboratory (not an independent third-party test) |
| Conclusion | Conforms |
Tests run on this lot
| Test | Method | Specification | Result |
|---|---|---|---|
| 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) |
What these results mean
HPLC purity is the share of UV-detectable material that elutes as the target compound; it is not the same as net peptide content, which also accounts for water and counter-ions. Identity means the measured mass matched the mass calculated for the compound. A certificate reports only the tests run on this lot; endotoxin, sterility and contaminant panels are not part of standard lot release. How to read a certificate of analysis.
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