Certificate of Analysis
Doc No.: CoA-SEMAX-0525
Rev.: 1.0
Issued: 2026-03-08
Product Identification
Semax 5 mg
- Catalog No.
- PEPTIDE-SEMAX
- CAS No.
- 80714-61-0
- Chemical Name
- Semax 5 mg
- Net Content per Vial
- 1 × 5 mg vial
- Package Configuration
- 1 × 5 mg vial
- Batch / Lot No.
- PS-2604-0525
- Manufacture Date
- 2026-03-05
- Retest Date
- 2029-03-05
- Country of Origin
- European Union
Physical and Chemical Properties
- Molecular Weight
- 813.9 g/mol
- Appearance
- White to off-white lyophilized solid
- Solubility
- Bacteriostatic water · 0.9 % NaCl
- Storage Conditions
- Lyophilized: −20 °C / 36 months · 4 °C / 24 months · 15 °C / 3 months
Reconstituted: −80 °C / 6 months · −20 °C / 1 month · 4 °C / 1 week
Analytical Data
| Test Parameter |
Method |
Specification |
Result |
Status |
| Appearance |
Visual inspection |
White to off-white lyophilized solid |
White to off-white lyophilized solid |
Pass |
| Identity (Mass) |
ESI-MS |
[M+H]⁺ = 814.9 ± 0.5 |
814.8 |
Pass |
| Purity (HPLC) |
RP-HPLC, UV 220 nm |
≥ 99.0 % |
99.35 % |
Pass |
| Single Impurity (max.) |
RP-HPLC, UV 220 nm |
≤ 0.50 % |
0.36 % |
Pass |
| Amino Acid Composition |
Acid hydrolysis / AAA |
Conforms to theoretical ratios |
Conforms |
Pass |
| Acetate Content |
Ion chromatography |
≤ 12.0 % |
8.5 % |
Pass |
| TFA Content |
RP-HPLC, UV 220 nm |
≤ 0.50 % |
< 0.10 % |
Pass |
| Water Content |
Karl Fischer |
≤ 6.0 % |
2.8 % |
Pass |
| Net Peptide Content |
Calculated (HPLC × AAA × H₂O × counter-ion) |
≥ 80.0 % |
88.8 % |
Pass |
| Bacterial Endotoxins |
LAL, gel-clot · USP <85> |
< 5 EU/mg |
< 0.5 EU/mg |
Pass |
| Bioburden |
USP <61> |
< 100 CFU/g |
< 10 CFU/g |
Pass |
Conclusion
Lot PS-2604-0525 has been tested using validated analytical methods and complies with all listed specifications. This batch is released for research distribution.
Caution: This product is supplied for laboratory research use only. It has not been evaluated by any regulatory authority for safety or efficacy in humans or animals. Not for diagnostic, therapeutic, food, or cosmetic use. Handle in accordance with good laboratory practice.
Quality Control Analyst
A. Petrov
Anya Petrov, MSc
Date: 2026-03-05
Quality Assurance Approver
A. Ribeiro
Dr. Ana Ribeiro
Date: 2026-03-08
Download PDF