Analysecertifikat: Selank, batch ATSEL-10-2507-01
Selank, batch ATSEL-10-2507-01, testet af det uafhængige laboratorium Analyton Labs, certifikat AN-2026-00007 udstedt den 22. september 2026: renhed 99.07 ± 0.20 % ved RP-HPLC, 9.87 mg peptid pr. hætteglas, trifluoracetat ikke påvist, bakterielle endotoksiner < 10 EU/mg, i alt 21 bestemmelser.
- Produkt
- Selank
- Batch
- ATSEL-10-2507-01
- Certifikatnummer
- AN-2026-00007
- Laboratorium
- Analyton Labs
- Udstedt
- Prøve
- Selank, lyophilised powder, vial labelled 10 mg
Oversigt over resultater, 21 bestemmelser
Metoder og resultater er angivet på engelsk, præcis som laboratoriet har registreret dem.
| Bestemmelse | Metode | Resultat | Specifikation |
|---|---|---|---|
| Appearance | Visual | White to off-white powder | White to off-white powder |
| Purity | RP-HPLC, C18, 214 nm, area % | 99.07 ± 0.20 % (k = 2) | >= 98.0 % |
| Related substances | RP-HPLC, 214 nm; LOD 0.01 %, LOQ 0.03 %, reporting threshold 0.05 % | Largest single impurity 0.52 % at RRT 0.90 (± 0.03 %); total impurities 0.93 %, i.e. 0.092 mg per vial | Single <= 1.0 %, total <= 2.0 % |
| Impurity profile | RP-HPLC with LC-HRMS assignment | RRT 0.90, 0.52 %, -97.05 Da (des-Pro); RRT 0.94, 0.41 %, truncated sequence (des-Arg) | Peaks above 0.05 % reported (ICH Q3B) |
| Net peptide content | Assay | 87.93 ± 1.2 % w/w (k = 2) | |
| Fill weight | Gravimetric | 11.22 ± 0.05 mg | Labelled 10 mg |
| Peptide per vial | Calculated from fill weight and net peptide content | 9.87 mg per vial labelled 10 mg, i.e. 98.7 % of label | 95 to 105 % of label |
| Vial-to-vial consistency | Gravimetric, two vials of the batch | 11.22 and 11.57 mg, difference 3.1 % | <= 5 % |
| Counter-ion content | Ion chromatography, suppressed conductivity | Acetate 7.71 % w/w (± 0.46 %), i.e. 0.87 mg per vial | |
| Trifluoroacetate | Ion chromatography, LOQ 20 ppm | Not detected | |
| Water content | Coulometric Karl Fischer, USP <921> | 1.93 ± 0.10 % w/w (k = 2), i.e. 0.22 mg per vial | |
| Mass balance | Peptide + counter-ion + water | 87.93 + 7.71 + 1.93 = 97.57 % (± 1.3 %) | Close to 100 % |
| pH | Potentiometric, 10 mg/ml in water | 5.2 | 4.4 to 6.0 |
| Solubility | Visual, 10 mg/ml and 1 mg/ml | >= 10 mg/ml in water and in bacteriostatic water; clear, colourless, free of particles within 30 s | Clear solution |
| Bacterial endotoxins | Bacterial endotoxins test (LAL), USP <85>, limit test | < 10 EU/mg (limit test at the specification limit) | <= 10 EU/mg |
| Sterility | Membrane filtration, USP <71>; fluid thioglycollate 30 to 35 °C and soya bean casein digest 20 to 25 °C | No growth after 14 days, 2 vials | No growth |
| Microbial enumeration | Plate method, USP <61> and <62> | TAMC < 10 CFU/g, TYMC < 10 CFU/g; E. coli, Salmonella, S. aureus and P. aeruginosa absent in 1 g | TAMC <= 1000 CFU/g, TYMC <= 100 CFU/g, specified organisms absent |
| Residual solvents | Headspace GC, USP <467> | Acetonitrile 45 ppm; N,N-dimethylformamide, methanol, dichloromethane, diethyl ether, diisopropyl ether and piperidine each < 10 ppm (LOQ 10 ppm) | ICH Q3C: acetonitrile <= 410, DMF <= 880, methanol <= 3000, dichloromethane <= 600, ethers <= 5000 ppm |
| Elemental impurities | ICP-MS after microwave digestion (HNO3/H2O2), USP <233> | Cd, Pb, As, Hg < 0.05 µg/g; Co, V, Ni < 0.10 µg/g, all below LOQ | ICH Q3D(R2) Class 1 and 2A, parenteral PDE |
| Chiral purity (D-amino acids) | Acid hydrolysis (6 M DCl in D2O, 110 °C, 24 h), Marfey's derivatisation (FDAA), LC-MS | D-Thr 0.05 %, others < 0.05 %; Gly achiral; sum of D-forms 0.11 % | Each D-amino acid <= 0.2 %, sum of D-forms <= 0.5 % |
| Compound screening | LC-HRMS full scan, m/z 100 to 2000, against library: fentanyl and analogues, Semax, protected intermediates (tBu, Boc, Trt, Pbf, Fmoc), free amino acids | None detected above 0.05 % area | No foreign compound above 0.05 % area |
Filens SHA-256: e047461ff15b25ea94d41a3aacdc617e4c69f9d2ca334e83e63df4e9fa9cbb01
Forskningsmateriale. Certifikatet beskriver batchens egenskaber, ikke egnethed til nogen form for brug på mennesker eller dyr.
