Сертификат за анализ: PT-141, партида ATPT1-10-2505-01
PT-141, партида ATPT1-10-2505-01, изпитана от независимата лаборатория Analyton Labs, сертификат AN-2026-00010, издаден на 22 септември 2026 г.: чистота 99.30 ± 0.20 % по метода RP-HPLC, 8.87 mg пептид във флакон, трифлуороацетат < 20 ppm, бактериални ендотоксини < 0.05 EU/mg, общо 21 определяния.
- Продукт
- PT-141
- Партида
- ATPT1-10-2505-01
- Номер на сертификата
- AN-2026-00010
- Лаборатория
- Analyton Labs
- Издаден
- Проба
- PT-141, lyophilised powder, vial labelled 10 mg
Обобщение на резултатите, 21 определяния
Методите и резултатите са дадени на английски точно както ги е записала лабораторията.
| Определяне | Метод | Резултат | Спецификация |
|---|---|---|---|
| Appearance | Visual | White to off-white powder | White to off-white powder |
| Purity | RP-HPLC, C18, 214 nm (280 nm control trace), area % | 99.30 ± 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 0.39 % at RRT 1.08 (± 0.03 %); total impurities 0.70 %, i.e. 0.062 mg per vial | Single <= 1.0 %, total <= 2.0 % |
| Impurity profile | RP-HPLC with LC-HRMS assignment | RRT 0.90, 0.12 %, +16/+32 Da (Trp oxidation); RRT 0.93, 0.09 %, -42.01 Da (des-acetyl at the N-terminus); RRT 1.03, 0.10 %, same mass (epimer); RRT 1.08, 0.39 %, +18.01 Da (opened Asp-Lys lactam, linear form) | Peaks above 0.05 % reported (ICH Q3B) |
| Net peptide content | Assay | 88.85 ± 1.2 % w/w (k = 2) | |
| Fill weight | Gravimetric | 9.98 ± 0.05 mg | Labelled 10 mg |
| Peptide per vial | Calculated from fill weight and net peptide content | 8.87 mg per vial labelled 10 mg, i.e. 88.7 % of label | 95 to 105 % of label |
| Vial-to-vial consistency | Gravimetric, two vials of the batch | 9.98 and 10.23 mg, difference 2.5 %; purity of both within 0.1 % | <= 5 % |
| Counter-ion content | Ion chromatography, suppressed conductivity | Acetate 6.09 % w/w (± 0.37 %), i.e. 0.61 mg per vial | |
| Trifluoroacetate | Ion chromatography, LOQ 20 ppm | < 20 ppm; chloride and phosphate below LOQ | <= 1000 ppm |
| Water content | Coulometric Karl Fischer, USP <921> | 4.50 ± 0.23 % w/w (k = 2), i.e. 0.45 mg per vial | <= 8.0 % |
| Mass balance | Peptide + counter-ion + water | 88.85 + 6.09 + 4.50 = 99.44 % (± 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 (< 0.50 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, Melanotan II (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 |
SHA-256 на файла: aa9fe5a02d13ae7036b503d67443c0a18e4e6e9a9180a5600df6ca5b01b2ccaf
Изследователски материал. Сертификатът описва свойствата на партидата, а не пригодността за каквато и да е употреба при хора или животни.
