Certifikat analize: TB-500, serija ATTB5-10-2508-01
TB-500, serija ATTB5-10-2508-01, testiral neodvisni laboratorij Analyton Labs, certifikat AN-2026-00011, izdan 22. september 2026: čistost 99.78 ± 0.20 % z metodo RP-HPLC, 9.89 mg peptida na vialo, trifluoroacetat < 20 ppm, bakterijski endotoksini < 0.05 EU/mg, skupaj 21 določitev.
- Izdelek
- TB-500
- Serija
- ATTB5-10-2508-01
- Številka certifikata
- AN-2026-00011
- Laboratorij
- Analyton Labs
- Datum izdaje
- Vzorec
- TB-500, lyophilised powder, vial labelled 10 mg
Pregled rezultatov, 21 določitev
Metode in rezultati so navedeni v angleščini, natanko tako, kot jih je zabeležil laboratorij.
| Določitev | Metoda | Rezultat | Specifikacija |
|---|---|---|---|
| Appearance | Visual | White to off-white powder | White to off-white powder |
| Purity | RP-HPLC, C18, 214 nm, area % | 99.78 ± 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 0.13 % at RRT 1.03 (± 0.03 %); total impurities 0.22 %, i.e. 0.022 mg per vial | Single <= 1.0 %, total <= 2.0 % |
| Impurity profile | RP-HPLC with LC-HRMS assignment | RRT 0.93, 0.09 %, -42.01 Da (des-acetyl at the N-terminus); RRT 1.03, 0.13 %, +0.98 Da (deamidation of Gln) | Peaks above 0.05 % reported (ICH Q3B) |
| Net peptide content | Assay | 87.60 ± 1.2 % w/w (k = 2) | |
| Fill weight | Gravimetric | 11.29 ± 0.05 mg | Labelled 10 mg |
| Peptide per vial | Calculated from fill weight and net peptide content | 9.89 mg per vial labelled 10 mg, i.e. 98.9 % of label | 95 to 105 % of label |
| Vial-to-vial consistency | Gravimetric, two vials of the batch | 11.29 and 11.57 mg, difference 2.5 %; purity of both within 0.1 % | <= 5 % |
| Counter-ion content | Ion chromatography (cation) | L-arginine 8.78 % w/w (± 0.53 %), i.e. 0.99 mg per vial | |
| Trifluoroacetate | Ion chromatography, LOQ 20 ppm | < 20 ppm; acetate, chloride and phosphate below LOQ | <= 1000 ppm |
| Water content | Coulometric Karl Fischer, USP <921> | 3.42 ± 0.17 % w/w (k = 2), i.e. 0.39 mg per vial | |
| Mass balance | Peptide + counter-ion + water | 87.60 + 8.78 + 3.42 = 99.80 % (± 1.3 %) | Close to 100 % |
| pH | Potentiometric, 10 mg/ml in water | 6.6 | 5.8 to 7.4 |
| 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 | Kinetic chromogenic LAL, USP <85> | < 0.05 EU/mg (< 0.56 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-Thr 0.05 %, D-Glu 0.05 %, D-Gln 0.05 %, others < 0.05 %; 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, BPC-157, GHK-Cu, thymosin beta-4 (4963 Da), 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 datoteke: 8ffd56aca8ef4720521dc295014dc10d5908c851576f90e65aa0468d1664c51f
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