Analysecertifikat: Epithalon, batch ATEPI-10-2512-01
Epithalon, batch ATEPI-10-2512-01, testet af det uafhængige laboratorium Analyton Labs, certifikat AN-2026-00006 udstedt den 22. september 2026: renhed 99.93 ± 0.20 % ved RP-HPLC, 9.21 mg peptid pr. hætteglas, trifluoracetat ikke påvist, bakterielle endotoksiner < 0.05 EU/mg, i alt 21 bestemmelser.
- Produkt
- Epithalon
- Batch
- ATEPI-10-2512-01
- Certifikatnummer
- AN-2026-00006
- Laboratorium
- Analyton Labs
- Udstedt
- Prøve
- Epithalon, 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 % | 99.93 ± 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 0.07 % at RRT 0.96 (± 0.03 %); total impurities 0.07 %, i.e. 0.006 mg per vial | Single <= 1.0 %, total <= 2.0 % |
| Impurity profile | RP-HPLC with LC-HRMS assignment | RRT 0.96, 0.07 %, same mass (isoAsp) | Peaks above 0.05 % reported (ICH Q3B) |
| Net peptide content | Assay | 84.14 ± 1.2 % w/w (k = 2) | |
| Fill weight | Gravimetric | 10.95 ± 0.05 mg | Labelled 10 mg |
| Peptide per vial | Calculated from fill weight and net peptide content | 9.21 mg per vial labelled 10 mg, i.e. 92.1 % of label | 95 to 105 % of label |
| Vial-to-vial consistency | Gravimetric, two vials of the batch | 10.95 and 10.90 mg, difference 0.5 % | <= 5 % |
| Counter-ion content | Ion chromatography, suppressed conductivity | Acetate 9.50 % w/w (± 0.57 %), i.e. 1.04 mg per vial | |
| Trifluoroacetate | Ion chromatography, LOQ 20 ppm | Not detected | |
| Water content | Coulometric Karl Fischer, USP <921> | 5.80 ± 0.29 % w/w (k = 2), i.e. 0.64 mg per vial | <= 8.0 % |
| Mass balance | Peptide + counter-ion + water | 84.14 + 9.50 + 5.80 = 99.44 % (± 1.3 %) | Close to 100 % |
| pH | Potentiometric, 10 mg/ml in water | 5.2 | 4.4 to 6.0 |
| Solubility | Visual | >= 100 mg/ml in water | >= 60 mg/ml |
| Bacterial endotoxins | Kinetic chromogenic LAL, USP <85> | < 0.05 EU/mg (< 0.55 EU per vial) | <= 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-Asp 0.12 %, D-Glu 0.05 %, D-Ala < 0.05 %; Gly achiral; sum of D-forms 0.19 % | 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, DSIP, pinealon, 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: 7fc9fb4c0572866e3e988b1cf6c4a027596d5ee34f52b97283b3fbec67d2382b
Forskningsmateriale. Certifikatet beskriver batchens egenskaber, ikke egnethed til nogen form for brug på mennesker eller dyr.
