Analīzes sertifikāts: Melanotan 2, partija ATMT2-10-2407-01
Melanotan 2, partija ATMT2-10-2407-01, pārbaudījusi neatkarīgā laboratorija Analyton Labs, sertifikāts AN-2026-00004 izsniegts 2026. gada 22. septembris: tīrība 99.65 ± 0.20 % (RP-HPLC), 9.05 mg peptīda uz flakonu, trifluoracetāts < 20 ppm, bakteriālie endotoksīni < 0.05 EU/mg, kopā 21 noteikšanas.
- Produkts
- Melanotan 2
- Partija
- ATMT2-10-2407-01
- Sertifikāta numurs
- AN-2026-00004
- Laboratorija
- Analyton Labs
- Izsniegšanas datums
- Paraugs
- MT-2 (Melanotan II), lyophilised powder, vial labelled 10 mg
Rezultātu kopsavilkums, 21 noteikšanas
Metodes un rezultāti ir norādīti angļu valodā tieši tā, kā tos reģistrējusi laboratorija.
| Noteikšana | Metode | Rezultāts | Specifikācija |
|---|---|---|---|
| Appearance | Visual | White to off-white powder | White to off-white powder |
| Purity | RP-HPLC, C18, 214 nm (280 nm control trace), area % | 99.65 ± 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 0.20 % at RRT 1.08 (± 0.03 %); total impurities 0.35 %, i.e. 0.032 mg per vial | Single <= 1.0 %, total <= 2.0 % |
| Impurity profile | RP-HPLC with LC-HRMS assignment | RRT 0.90, 0.10 %, +16/+32 Da (Trp oxidation); RRT 0.93, 0.05 %, -42.01 Da (des-acetyl at the N-terminus); RRT 1.08, 0.20 %, +18.01 Da (opened Asp-Lys lactam, linear form) | Peaks above 0.05 % reported (ICH Q3B) |
| Net peptide content | Amino acid analysis after acid hydrolysis | 86.50 ± 1.2 % w/w (k = 2) | >= 85 % |
| Fill weight | Gravimetric | 10.46 ± 0.05 mg | Labelled 10 mg |
| Peptide per vial | Calculated from fill weight and net peptide content | 9.05 mg per vial labelled 10 mg, i.e. 90.5 % of label | 95 to 105 % of label |
| Vial-to-vial consistency | Gravimetric, two vials of the batch | 10.46 and 10.72 mg, difference 2.5 %; purity of both within 0.1 % | <= 5 % |
| Counter-ion content | Ion chromatography, suppressed conductivity | Acetate 9.00 % w/w (± 0.54 %), i.e. 0.94 mg per vial; 1.8 mol acetate per mol peptide at 3 basic sites | <= 12 % |
| Trifluoroacetate | Ion chromatography, LOQ 20 ppm | < 20 ppm; chloride and phosphate below LOQ | <= 1000 ppm |
| Water content | Coulometric Karl Fischer, USP <921> | 4.00 ± 0.20 % w/w (k = 2), i.e. 0.42 mg per vial | <= 8.0 % |
| Mass balance | Peptide + counter-ion + water | 86.50 + 9.00 + 4.00 = 99.50 % (± 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 to faintly yellow, free of particles within 30 s. Hydrophobic cyclic peptide: swirl briefly at 10 mg/ml, do not freeze the solution | Clear solution |
| Bacterial endotoxins | Kinetic chromogenic LAL, USP <85> | < 0.05 EU/mg (< 0.52 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-His 0.10 %, others < 0.05 %; intended D-Phe >= 99.5 % D, L-epimer < 0.5 %; sum of D-forms 0.30 % | 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, PT-141 (same ring, differs only at the terminus), protected intermediates (tBu, Boc, Trt, Pbf, Fmoc), free amino acids | None detected above 0.05 % area | No foreign compound above 0.05 % area |
Faila SHA-256: 0d928a56342fccdc814ccf1632566b5304e255bf534a0ffac7d00e54fce13924
Pētniecības materiāls. Sertifikāts apraksta partijas īpašības, nevis tās piemērotību lietošanai cilvēkiem vai dzīvniekiem.
